CClinicalTrials.gg
Not yet recruitingNCT06134765Updated Nov 18, 2023

Bemalenograstim Alfa for the Prevention in Patients With Colorectal Cancer/Pancreatic Cancer

A Phase 2 interventional study of Bemalenograstim alfa in Colorectal Cancer and Pancreatic Cancer, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Oct 2024, 1 year 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
89
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

A multi-cohort, open-label, multicenter exploratory clinical study of Bemalenograstim alfa for the prevention of reduced absolute neutrophil count(ANC) in patients with colorectal cancer/pancreatic cancer following a bi-weekly chemotherapy regimen.A total of 89 patients are planned to be enrolled.

Read the detailed description

This multi-cohort, open-label, multicenter exploratory clinical study enrolled 89 patients with colorectal cancer and pancreatic cancer who were scheduled to receive at least 2 courses of a two-week chemotherapy regimen. The study was divided into two cohorts: Cohort 1 was colorectal cancer or pancreatic cancer patients receiving FOLFOXIRI or mFOLFIRINOX in combination with or without targeted drugs, and cohort 2 was colorectal cancer patients receiving FOLFIRI in combination with or without targeted drugs. Patients meeting the inclusion criteria received Bemalenograstim alfa injection (20mg/ time, subcutaneous injection) 24-48h after each course of chemotherapy, and Bemalenograstim alfa injection was used until the change of chemotherapy regimen or the fourth course of chemotherapy, whichever occurred first. After the subjects completed 2 courses of treatment, the follow-up treatment was carried out according to the diagnosis and treatment routine. Investigators need to ensure that the first course of chemotherapy is at the recommended dose; For the second to fourth course of treatment, delayed dosing or dose adjustment due to toxicity is allowed, and the chemotherapy dose is allowed to be adjusted by ±10%.

02

Conditions studied

  • Colorectal Cancer
  • Pancreatic Cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 89 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. The patients voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up;
  2. Age 18 and above, male or female;
  3. Patients with locally advanced or advanced colorectal or pancreatic cancer confirmed by histology or cytology are scheduled to receive at least 2 courses of FOLFIRI, FOLFOXIRI, or mFOLFIRINOX with or without targeted therapy as part of first-line therapy (excluding those who relapse within 6 months after the end of adjuvant therapy) ;
  4. Eastern Cancer Collaboration Group (ECOG) physical status (PS) score: 0-1;
  5. Adequate organ and bone marrow function meets the following criteria:

    1. Blood routine examination standards should be met (no blood transfusion or blood products within 14 days, no G-CSF and other hematopoietic stimulating factors are used to correct): hemoglobin content (HB) ≥80g/L; Neutrophil count (ANC) ≥1.5×109/L; Platelet count (PLT) ≥100×109/L.
    2. Biochemical examination shall meet the following criteria: Serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN); ALT and AST ≤ 2.5 ULN; If with liver metastasis, ALT and AST ≤ 5× ULN; Serum creatinine ≤ 1.5× ULN.
    3. Left ejection fraction >50%.
  6. Infertile women, i.e. those who have been through menopause for at least one year or who have undergone sterilization (bilateral tubal ligation, double ovaries removal, or hysterectomy); Fertile patients agreed to use appropriate contraceptive methods: condoms, foam, gel, diaphragm, intrauterine device (IUD), birth control pills (given orally or by injection) for 1 month before the start of the trial and 30 days after the end of the study.
  7. The investigators determined that the patient could tolerate the treatment of Bemalenograstim Alfa.

Exclusion criteria

Exclusion Criteria:

  1. Acute congestive heart failure, cardiomyopathy, or myocardial infarction as diagnosed by clinical, electrocardiogram or other means;
  2. Rubber allergic people;
  3. Patients who had received radiotherapy for bone lesions (patients who had received radiotherapy for lesions other than bone lesions could be enrolled 4 weeks later) ;
  4. Have received a bone marrow or stem cell transplant;
  5. Pregnant or lactating women;
  6. Known to be seropositive for human immunodeficiency virus (HIV) or have AIDS;
  7. Active tuberculosis disease; Or a recent history of contact with a person with TB, unless the tuberculin test is negative, Or tuberculosis patients undergoing treatment; Or a chest radiograph to check suspected cases;
  8. Patients with alcohol or substance abuse, which affected their adherence to the study;以上
  9. Known allergy to granulocyte colony-stimulating factors or excipients of drugs;
  10. Received recombinant human granulocyte stimulating factor treatment within 6 weeks before inclusion;
  11. Patients with a diagnosis of primary malignancy other than colorectal or pancreatic cancer were accompanied by the following, except: 1) malignancy in complete remission for at least 2 years prior to enrollment and without additional treatment during the study period; 2) non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; 3) Carcinoma in situ with adequate treatment and no evidence of disease recurrence;
  12. Use of other investigational drugs within 1 month prior to study enrollment;
  13. The investigators believe that the patients have diseases or symptoms that are not suitable for participation in the study and that the study drugs may harm the patient's health or affect the judgment of adverse events;
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
89 participants (estimated)

Study arms

  • Experimental
    Bemalenograstim alfa for the prevention of reduced ANC in patients with colorectal/pancreatic cancer

    Patients with colorectal cancer and pancreatic cancer(N=32)receive FOLFOXIRI or mFOLFIRINOX with or without targeted therapy. Subcutaneous injection of Bemalenograstim alfa 20mg/ time 24-48h after each cycle of chemotherapy.

    Drug: Bemalenograstim alfa

  • Experimental
    Bemalenograstim alfa for the prevention of reduced ANC in patients with colorectal cancer

    Patients with colorectal cancer(N=57)receiving FOLFIRI with or without targeted therapy.Subcutaneous injection of Bemalenograstim alfa, 20mg/ time, 24-48h after each cycle of chemotherapy.

    Drug: Bemalenograstim alfa

Interventions

  • DrugBemalenograstim alfa

    Bemalenograstim alfa,20mg, once every treatment

    Also known as: F-627

06

What researchers measure

Primary outcomes

  1. The incidence of reduced absolute neutrophil count(ANC) of grade ≥3 in the first cycle of chemotherapy

    The incidence of reduced absolute neutrophil count(ANC) of grade ≥3 in the first cycle of chemotherapy

    Time frame: From Baseline to primary completion date, about 18 months

07

Study locations

1 site
  • the Second Affiliated Hospital of Medical College of Zhejiang University
    Hangzhou, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06134765
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Nov 18, 2023
Start date
Nov 30, 2023 (estimated)
Primary completion
Oct 30, 2024 (estimated)
Completion
Mar 30, 2025 (estimated)
Last update
Nov 18, 2023

Study contacts

Caixia Dong
Contact
dcx_1982@163.com
+86-15068882349
Ying Yuan
Contact
yuanying1999@zju.edu.cn
+86-13858193601

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion