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CompletedNCT04174599Updated Apr 20, 2025Results posted

Study to Compare the Efficacy and Safety of F-627 and GRAN®

A Phase 3 interventional study of F-627 and GRAN® in Breast Cancer and Neutropenia, sponsored by EVIVE Biotechnology. Completed at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-20.

Sponsored by EVIVE Biotechnology · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Apr 2018, registered Jul 2019).
Phase
Phase 3
Study type
Interventional
Enrollment
242
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

A Phase III, Multi-Center, Randomized, Open-Label, Active-Controlled Trial to Compare the Efficacy and Safety of Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein (F-627) and Recombinant Human Granulocyte Colony Stimulating Factor (GRAN®) in the Prophylactic Treatment for Chemotherapy-Induced Neutropenia

Read the detailed description

Study Stage: Phase III

Study Population: Female patients with breast cancer will be enrolled to receive at least 4 cycles of Epirubicin + Cyclophosphamide (EC) chemotherapy, that is: epirubicin 100 mg/m\^2 and cyclophosphamide 600 mg/m\^2.

Study Design: A multi-center, randomized, open-label, active-controlled phase III clinical trial

02

Conditions studied

  • Breast Cancer
  • Neutropenia

Browse trials for

03

In context

Neutropenia

396 studies on the registry are indexed under Neutropenia; 57 are open to participants now.

This study's enrollment of 242 is above the median of 93 across 276 interventional studies indexed under Neutropenia.

Browse Neutropenia studies →

Lead sponsor

EVIVE Biotechnology is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Willing to sign the informed consent form and able to comply with protocol requirements;
  2. 18-75 years old;
  3. Female postoperative patients with breast cancer who require adjuvant chemotherapy, and are planned to receive at least 4 cycles of EC chemotherapy, namely epirubicin 100 mg/m\^2 + cyclophosphamide 600 mg/m\^2;
  4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
  5. Absolute neutrophil count (ANC) ≥ 2.0 × 10\^9/L, hemoglobin (Hb) ≥ 11.0 g/dL, and platelet (PLT) ≥ 100 × 10\^9/L prior to enrollment;
  6. Hepatic and renal functions: Total bilirubin ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, serum creatinine ≤ 1.5 × ULN;
  7. Left ventricular ejection fraction > 50%;
  8. Women without child-bearing potential, i.e., women who have had menopause for at least 1 year or who have undergone sterilization (bilateral tubal ligation, double oophorectomy or hysterectomy); patients with child-bearing potential should agree to take appropriate contraceptive measures, including condoms, spermicidal condoms, foams, gels, contraceptive barrier, intrauterine devices (IUD), and contraceptives (oral or injection), starting from 1 month before the start of the study until 30 days after the end of the study.

Exclusion criteria

Exclusion Criteria:

  1. Radiation therapy within 4 weeks prior to enrollment;
  2. Patients with breast cancer who have received neoadjuvant chemotherapy before surgery;
  3. Prior bone marrow or stem cell transplant;
  4. With other malignant tumors other than breast cancer;
  5. Patients who have received a treatment with recombinant human granulocyte colony stimulating factor within 6 weeks prior to randomization;
  6. Diagnosed with acute congestive heart failure, cardiomyopathy, or myocardial infarction by clinical diagnosis, ECG or other approaches;
  7. With any disease that may cause splenomegaly;
  8. With acute infection, chronic active Hepatitis B within 1 year (unless patients tested negative for HBsAg prior to enrollment), or Hepatitis C;
  9. Women in pregnancy or breastfeeding;
  10. Known HIV positive or AIDS;
  11. With active tuberculosis (TB); history of TB exposure, unless negative for tuberculin test; TB patients undergoing treatment; or suspected TB evaluated by chest x-ray;
  12. With sickle cell anemia;
  13. With alcohol or drug abuse that may affect the compliance with the study;
  14. With known hypersensitivity to granulocyte colony stimulating factor or excipients;
  15. Have received any other investigational drug within 1 month or 5 half-lives of the investigational drugs prior to enrollment (whichever is longer);
  16. Patients with diseases or symptoms unsuitable for participating in the trial. For example, the study drugs may compromise the health of the patient or the assessment of adverse events may be affected.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
242 participants (actual)

Study arms

  • Experimental
    F-627

    F-627 (20 mg/dose, s.c.) on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy

    Drug: F-627

  • Active comparator
    GRAN®

    GRAN® \[5 μg/kg/day, s.c., once daily (± 4 h) up to 2 weeks or until neutrophil count returns to 5.0 × 10\^9/L\] on day 3 of each cycle, i.e., 48 ± 4 h after the start of chemotherapy

    Drug: GRAN®

Interventions

  • DrugF-627

    Day 3 of each cycle, i.e., 48 ± 4 h after starting chemotherapy

    Also known as: Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein

  • DrugGRAN®

    Since day 3 of each cycle, i.e., 48 ± 4 h after starting chemotherapy, continuous treatment for ≤ 2 weeks or until ANC recovers to 5.0 × 10\^9/L from nadir (investigators may refer to ANC test results from the Department of Laboratory Medicine of each study sites to decide when to discontinue GRAN®)

    Also known as: Filgrastim

06

What researchers measure

Primary outcomes

  1. Duration of Grade 3 or 4 Neutropenia (ANC <1.0×10^9/L) in Cycle 1

    Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

    Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)

Secondary outcomes

  1. Number of Participants With Grade 3 or 4 Neutropenia in Cycle 1

    Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L

    Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)

  2. Number of Participants With Grade 3 or 4 Neutropenia in Cycle 2

    Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L

    Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)

  3. Number of Participants With Grade 3 or 4 Neutropenia in Cycle 3

    Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L

    Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)

  4. Number of Participants With Grade 3 or 4 Neutropenia in Cycle 4

    Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L

    Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)

  5. Duration of Grade 3 or 4 Neutropenia in Cycle 2

    Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

    Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)

  6. Duration of Grade 3 or 4 Neutropenia in Cycle 3

    Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

    Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)

  7. Duration of Grade 3 or 4 Neutropenia in Cycle 4

    Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

    Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)

  8. Number of Participants With Grade 4 Neutropenia in Cycle 1

    Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L.

    Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)

  9. Number of Participants With Grade 4 Neutropenia in Cycle 2

    Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L.

    Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)

  10. Number of Participants With Grade 4 Neutropenia in Cycle 3

    Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L.

    Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)

  11. Number of Participants With Grade 4 Neutropenia in Cycle 4

    Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L.

    Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)

  12. Duration of Grade 4 Neutropenia in Cycle 1

    Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

    Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)

  13. Duration of Grade 4 Neutropenia in Cycle 2

    Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

    Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)

  14. Duration of Grade 4 Neutropenia in Cycle 3

    Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

    Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)

  15. Duration of Grade 4 Neutropenia in Cycle 4

    Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

    Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)

  16. Overall Duration of Grade 3 or 4 Neutropenia in 4 Cycles

    Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

    Time frame: Overall 4, 21-day chemotherapy cycles(average 12 weeks)

  17. Number of Participants With Grade 2 or Greater Neutropenia in Cycle 1

    Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L

    Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)

  18. Number of Participants With Grade 2 or Greater Neutropenia in Cycle 2

    Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L

    Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)

  19. Number of Participants With Grade 2 or Greater Neutropenia in Cycle 3

    Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L

    Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)

  20. Number of Participants With Grade 2 or Greater Neutropenia in Cycle 4

    Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L

    Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)

  21. Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 1

    Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

    Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)

  22. Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 2

    Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

    Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)

  23. Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 3

    Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

    Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)

  24. Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 4

    Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

    Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)

  25. The Absolute Neutrophil Counts (ANC) Nadir From Day 3 to Day 13 of Cycle 1

    The minimum value of ANC measured from day 3 to day 13 of cycle 1

    Time frame: From day 3 to day 13 of cycle 1 (11 days)

  26. Number of Participants With Febrile Neutropenia (FN) in Cycle 1

    FN is defined as ANC \< 1.0 × 10\^9/L with fever (a single measurement of body temperature \>38.3 °C or body temperature ≥ 38.0 °C for more than 1 hr).

    Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)

  27. Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 1

    If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days.

    Time frame: Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)

  28. Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 2

    If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days.

    Time frame: Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)

  29. Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 3

    If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days.

    Time frame: Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)

  30. Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 4

    If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days.

    Time frame: Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)

07

Results

Posted Apr 20, 2025

Participant flow

Participant flow — Overall Study
MilestoneF-627GRAN®
Started122120
Completed113101
Not completed919

Outcome measures

PrimaryDuration of Grade 3 or 4 Neutropenia (ANC <1.0×10^9/L) in Cycle 1

Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Time frame:
Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Mean · days
Duration of Grade 3 or 4 Neutropenia (ANC <1.0×10^9/L) in Cycle 1
daysF-627GRAN®
Duration of Grade 3 or 4 Neutropenia (ANC <1.0×10^9/L) in Cycle 10.68 ± 1.1000.71 ± 0.967
SecondaryNumber of Participants With Grade 3 or 4 Neutropenia in Cycle 1

Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L

Time frame:
Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 1
ParticipantsF-627GRAN®
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 14151
SecondaryNumber of Participants With Grade 3 or 4 Neutropenia in Cycle 2

Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L

Time frame:
Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 2
ParticipantsF-627GRAN®
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 277
SecondaryNumber of Participants With Grade 3 or 4 Neutropenia in Cycle 3

Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L

Time frame:
Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 3
ParticipantsF-627GRAN®
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 3418
SecondaryNumber of Participants With Grade 3 or 4 Neutropenia in Cycle 4

Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L

Time frame:
Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 4
ParticipantsF-627GRAN®
Number of Participants With Grade 3 or 4 Neutropenia in Cycle 41010
SecondaryDuration of Grade 3 or 4 Neutropenia in Cycle 2

Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Time frame:
Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Mean · days
Duration of Grade 3 or 4 Neutropenia in Cycle 2
daysF-627GRAN®
Duration of Grade 3 or 4 Neutropenia in Cycle 20.1 ± 0.350.1 ± 0.25
SecondaryDuration of Grade 3 or 4 Neutropenia in Cycle 3

Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Time frame:
Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Mean · days
Duration of Grade 3 or 4 Neutropenia in Cycle 3
daysF-627GRAN®
Duration of Grade 3 or 4 Neutropenia in Cycle 30.0 ± 0.180.2 ± 0.54
SecondaryDuration of Grade 3 or 4 Neutropenia in Cycle 4

Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Time frame:
Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Mean · days
Duration of Grade 3 or 4 Neutropenia in Cycle 4
daysF-627GRAN®
Duration of Grade 3 or 4 Neutropenia in Cycle 40.1 ± 0.380.1 ± 0.41
SecondaryNumber of Participants With Grade 4 Neutropenia in Cycle 1

Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L.

Time frame:
Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Grade 4 Neutropenia in Cycle 1
ParticipantsF-627GRAN®
Number of Participants With Grade 4 Neutropenia in Cycle 11719
SecondaryNumber of Participants With Grade 4 Neutropenia in Cycle 2

Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L.

Time frame:
Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Grade 4 Neutropenia in Cycle 2
ParticipantsF-627GRAN®
Number of Participants With Grade 4 Neutropenia in Cycle 221
SecondaryNumber of Participants With Grade 4 Neutropenia in Cycle 3

Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L.

Time frame:
Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Grade 4 Neutropenia in Cycle 3
ParticipantsF-627GRAN®
Number of Participants With Grade 4 Neutropenia in Cycle 304
SecondaryNumber of Participants With Grade 4 Neutropenia in Cycle 4

Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L.

Time frame:
Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Grade 4 Neutropenia in Cycle 4
ParticipantsF-627GRAN®
Number of Participants With Grade 4 Neutropenia in Cycle 424
SecondaryDuration of Grade 4 Neutropenia in Cycle 1

Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Time frame:
Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Mean · days
Duration of Grade 4 Neutropenia in Cycle 1
daysF-627GRAN®
Duration of Grade 4 Neutropenia in Cycle 10.3 ± 0.690.2 ± 0.58
SecondaryDuration of Grade 4 Neutropenia in Cycle 2

Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Time frame:
Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Mean · days
Duration of Grade 4 Neutropenia in Cycle 2
daysF-627GRAN®
Duration of Grade 4 Neutropenia in Cycle 20.0 ± 0.130.0 ± 0.10
SecondaryDuration of Grade 4 Neutropenia in Cycle 3

Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Time frame:
Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Mean · days
Duration of Grade 4 Neutropenia in Cycle 3
daysF-627GRAN®
Duration of Grade 4 Neutropenia in Cycle 30.0 ± 0.000.1 ± 0.34
SecondaryDuration of Grade 4 Neutropenia in Cycle 4

Grade 4 neutropenia is defined as ANC \< 0.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Time frame:
Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Mean · days
Duration of Grade 4 Neutropenia in Cycle 4
daysF-627GRAN®
Duration of Grade 4 Neutropenia in Cycle 40.0 ± 0.130.0 ± 0.20
SecondaryOverall Duration of Grade 3 or 4 Neutropenia in 4 Cycles

Grade 3 defined as ANC \<1.0×10\^9/L and Grade 4 defined as ANC\<0.5×10\^9/L According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Time frame:
Overall 4, 21-day chemotherapy cycles(average 12 weeks)
Reported as:
Mean · days
Overall Duration of Grade 3 or 4 Neutropenia in 4 Cycles
daysF-627GRAN®
Overall Duration of Grade 3 or 4 Neutropenia in 4 Cycles0.9 ± 1.441.1 ± 1.43
SecondaryNumber of Participants With Grade 2 or Greater Neutropenia in Cycle 1

Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L

Time frame:
Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 1
ParticipantsF-627GRAN®
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 15867
SecondaryNumber of Participants With Grade 2 or Greater Neutropenia in Cycle 2

Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L

Time frame:
Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 2
ParticipantsF-627GRAN®
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 21614
SecondaryNumber of Participants With Grade 2 or Greater Neutropenia in Cycle 3

Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L

Time frame:
Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 3
ParticipantsF-627GRAN®
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 31430
SecondaryNumber of Participants With Grade 2 or Greater Neutropenia in Cycle 4

Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L

Time frame:
Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 4
ParticipantsF-627GRAN®
Number of Participants With Grade 2 or Greater Neutropenia in Cycle 42026
SecondaryDuration (Days) of Grade 2 or Greater Neutropenia in Cycle 1

Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Time frame:
Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Mean · days
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 1
daysF-627GRAN®
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 11.1 ± 1.301.0 ± 1.10
SecondaryDuration (Days) of Grade 2 or Greater Neutropenia in Cycle 2

Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Time frame:
Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Mean · days
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 2
daysF-627GRAN®
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 20.2 ± 0.500.2 ± 0.50
SecondaryDuration (Days) of Grade 2 or Greater Neutropenia in Cycle 3

Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Time frame:
Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Mean · days
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 3
daysF-627GRAN®
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 30.1 ± 0.420.4 ± 0.67
SecondaryDuration (Days) of Grade 2 or Greater Neutropenia in Cycle 4

Grade 2 or greater neutropenia is defined as ANC \< 1.5 × 10\^9/L. According to the study protocol, the outcome measure "Duration of Grade 3 or 4 Neutropenia (days)" applied to all participants with a valid ANC level, rather than those with an ANC level of \< 1.0 × 109/L. The value of 0 represents the participant experienced 0 days with Grade 3 or 4 Neutropenia (days). Whereas exclusion of a participant from the analysis indicates a lack of ANC data of the participant. The mean value was calculated as the sum of the durations (days) of ANC \< 1.0 × 109/L for all participants with valid ANC level (the numerator) divided by the number of participants (the denominator).

Time frame:
Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Mean · days
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 4
daysF-627GRAN®
Duration (Days) of Grade 2 or Greater Neutropenia in Cycle 40.3 ± 0.680.3 ± 0.63
SecondaryThe Absolute Neutrophil Counts (ANC) Nadir From Day 3 to Day 13 of Cycle 1

The minimum value of ANC measured from day 3 to day 13 of cycle 1

Time frame:
From day 3 to day 13 of cycle 1 (11 days)
Reported as:
Mean · 10^9 cell/L
The Absolute Neutrophil Counts (ANC) Nadir From Day 3 to Day 13 of Cycle 1
10^9 cell/LF-627GRAN®
The Absolute Neutrophil Counts (ANC) Nadir From Day 3 to Day 13 of Cycle 12.058 ± 1.5031.597 ± 1.197
SecondaryNumber of Participants With Febrile Neutropenia (FN) in Cycle 1

FN is defined as ANC \< 1.0 × 10\^9/L with fever (a single measurement of body temperature \>38.3 °C or body temperature ≥ 38.0 °C for more than 1 hr).

Time frame:
Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Count of participants · Participants
Number of Participants With Febrile Neutropenia (FN) in Cycle 1
ParticipantsF-627GRAN®
Number of Participants With Febrile Neutropenia (FN) in Cycle 112
SecondaryTime (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 1

If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days.

Time frame:
Cycle 1, the first of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Mean · days
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 1
daysF-627GRAN®
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 10.9 ± 1.011.0 ± 0.84
SecondaryTime (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 2

If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days.

Time frame:
Cycle 2, the second of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Mean · days
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 2
daysF-627GRAN®
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 20.5 ± 1.100.7 ± 0.99
SecondaryTime (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 3

If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days.

Time frame:
Cycle 3, the third of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Mean · days
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 3
daysF-627GRAN®
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 30.4 ± 0.870.9 ± 1.50
SecondaryTime (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 4

If the ANC nadir during the first 13 days of the cycle is \< 2.0 × 10\^9/L, the recovery time = ((date of ANC ≥ 2.0 ×10\^9/L) - (date of ANC reaching nadir within the cycle) + 1). If the ANC nadir in the first 13 days of the cycle is ≥2.0 × 10\^9/L, then the recovery time = 0 days.

Time frame:
Cycle 4, the last of 4, 21-day chemotherapy cycles (average 3 weeks)
Reported as:
Mean · days
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 4
daysF-627GRAN®
Time (Days) of ANC Nadir Recovers to 2.0 × 10^9/L in Cycle 40.7 ± 1.141.2 ± 1.73

Adverse events

Collected over Adverse events (AEs) are recorded from randomization until 30 days after the last dose of the study drug, including AEs that occurred prior to the randomization and worsened during the treatment period, e.g.average 95 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
F-6270/120 (0%)6/120 (5%)119/120 (99.2%)
GRAN®0/119 (0%)8/119 (6.7%)119/119 (100%)
Most frequent serious events
Most frequent serious events
EventF-627GRAN®
Neutrophil count decreasedInvestigations3/1203/119
Platelet count decreasedInvestigations3/1202/119
Febrile neutropeniaBlood and lymphatic system disorders1/1202/119
Drug-induced liver injuryHepatobiliary disorders0/1201/119
Lung adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1201/119
White blood cell count decreasedInvestigations1/1200/119
Jugular vein thrombosisVascular disorders1/1200/119
Most frequent other events
Showing 10 of 32
Most frequent other events
EventF-627GRAN®
NauseaGastrointestinal disorders104/120102/119
White blood cell count decreasedInvestigations79/12099/119
Neutrophil count decreasedInvestigations71/12099/119
AlopeciaSkin and subcutaneous tissue disorders93/12083/119
VomitingGastrointestinal disorders76/12089/119
AnaemiaBlood and lymphatic system disorders81/12079/119
Platelet count decreasedInvestigations56/12040/119
AstheniaGeneral disorders42/12035/119
Bone painMusculoskeletal and connective tissue disorders30/12040/119
Alanine aminotransferase increasedInvestigations36/12019/119

Baseline characteristics

The started participants were all the subjects randomized, but the baseline participants were those randomized subjects received one study drugs at least. A total of 242 subjects were enrolled and randomized. Only 239 randomized patients received one study drugs at least, and included in the full analysis set (FAS), which were consisted of the baseline population.

Age, Continuous
Age, Continuous(years)F-627GRAN®Total
Mean49.1 ± 9.3248.5 ± 9.1448.8 ± 9.21
Sex: Female, Male
Sex: Female, Male(Participants)F-627GRAN®Total
Female120119239
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)F-627GRAN®Total
Hispanic or Latino000
Not Hispanic or Latino120119239
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)F-627GRAN®Total
American Indian or Alaska Native000
Asian120119239
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)F-627GRAN®Total
China120119239
Height
Height(m)F-627GRAN®Total
Mean157.97 ± 5.061157.87 ± 5.524157.92 ± 5.286
Weight
Weight(kg)F-627GRAN®Total
Mean58.96 ± 8.94559.24 ± 8.48759.10 ± 8.703
Body mass index (BMI)
Body mass index (BMI)(kg/m^2)F-627GRAN®Total
Mean23.609 ± 3.27823.782 ± 3.33623.695 ± 3.301

1 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai 200032, China
09

References and documents

Study documents

  • Study protocol · Aug 7, 2018
  • Statistical analysis plan · Dec 6, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04174599
Lead sponsor
EVIVE Biotechnology
Responsible party
Sponsor
First posted
Nov 22, 2019
Start date
Apr 12, 2018
Primary completion
Jan 24, 2019
Completion
Jun 19, 2019
Results posted
Apr 20, 2025
Last update
Apr 20, 2025

Study contacts

Zhimin Shao, Doctor
principal investigator · Fudan University Shanghai Cancer Centre

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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