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TerminatedNCT02749526Updated Jul 29, 2022

Endostar Combined With MPFC Adjuvant Treatment of Esophageal Cancer Clinical Trial

A Phase 2 interventional study of "Endostar" and Liposo in Esophageal, sponsored by The First Affiliated Hospital with Nanjing Medical University. Terminated at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-29.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 2, Interventional, and Treatment

Why this study was terminated
low accrual rate
Phase
Phase 2
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Endostar ® (recombinant human endostatin) continuous intravenous infusion combined with mPFC neoadjuvant treatment of esophageal cancer arm, Ⅱ single-center clinical trial.

Read the detailed description
  1. Research purpose: Endostar (recombinant human endostatin) continuous intravenous infusion combined with chemotherapy for stage Ⅲ resectable or potentially resectable esophageal cancer efficacy and safety and to maintain the efficacy and safety.
  2. The main objectives: R0 resection rate

Secondary objectives:

  1. pCR rate
  2. 3-year disease-free survival
  3. Security and complications
  4. DFS, OS
  5. Quality of Life

3.The number of research centers and research time: This study intends to preside and implemented by the Jiangsu Provincial People's Hospital, Professor Gu Yanhong. The trial is scheduled to start in September 2015, planned to stop in June 2016 into the group, one patient surgery follow-up to the last end, get the primary endpoint and safety, surgical complications secondary endpoint. This study will continue to follow-up the patient DFS, OS and other secondary end points.

02

Conditions studied

  • Esophageal

Keywords

  • Recombinant human endostatin,Endo
03

In context

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 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
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with esophageal cancer confirmed by histology or cytology;
  • according to TNM staging for Ⅲ period, previous untreated can be removed and potentially resectable esophageal cancer patients;
  • can eat more than liquid diet;No signs before esophageal perforation;No distant metastasis;
  • male or female, age 18 and 75 years old or less or more;
  • ECOG PS 0 \~ 1 minute;
  • is expected to survive period for 3 months or more,
  • enough blood function: absolute neutrophil count (ANC) or 2 x 109 / L and the • platelet count 100 x 109 / L or higher acuity 9 g/dL and hemoglobin;Liver function
  • enough: upper limit of total bilirubin acuities were normal (ULN);AST and ALT acuities were 2.5 times the upper limit of normal (ULN);Alkaline phosphatase 5 times the upper limit of normal or less (ULN);
  • enough renal function, serum creatinine or less normal limit (ULN) or calculated creatinine clearance or 60 mL/min.
  • basic normal ecg, no healing trauma;
  • always not received anti-tumor drug treatment;
  • ever had had surgery patients, request to study treatment began to have more than 4 weeks, and the patient has recovered;
  • a complete uterus of female in the group within 28 days before the study must have a negative pregnancy test results (except amenorrhea has 24 months).If the pregnancy test from the first time for more than 7 days, is the need for urine pregnancy test validation (within 7 days before the first delivery).
  • prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions;

Exclusion criteria

Exclusion Criteria:

  • there is a clear taxol allergy history;
  • pregnancy, nursing mothers, or have fertility but not women using contraception;
  • the existing serious acute infection, and not be controlled;Or fester sex and chronic infection, wound in delay no more;
  • the original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension;
  • is not easy to control nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment;Primary brain tumors or CNS metastases illness did not get a control, has obvious symptoms in cranial hypertension or nerve spirit;
  • with bleeding tendency;
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Endostar combined with MPFC

    Chemotherapy regimens (er degree + mPFC) : Endostar: degrees 30 mg civ24h d0-6; Liposo: 135 mg/m2 D1; cisplatin: D1-3, 25 mg/m2 Gimeracil and Oteracil Potassium (Tegafur): (40 mg bid Tegafur), D1-14. A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy.

    Drug: "Endostar" · Drug: Liposo · Drug: cisplatin · Drug: Gimeracil and Oteracil Potassium (Tegafur)

Interventions

  • Drug"Endostar"

    30mg civ24h d0-6.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy.

  • DrugLiposo

    135mg/m2 D1.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy.

  • Drugcisplatin

    25mg/m2 D1-3.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy.

  • DrugGimeracil and Oteracil Potassium (Tegafur)

    40mg bid,D1-14.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy.

06

What researchers measure

Primary outcomes

  1. R0 Resection rate

    Time frame: up to 8 months

Secondary outcomes

  1. pCR rate

    Time frame: up to 10 months

07

Study locations

1 site
  • The First Affiliated Hospital with Nanjing Medical University
    Nanjing, Jiangsu 210000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02749526
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Responsible party
Sponsor
First posted
Apr 25, 2016
Start date
Apr 2016
Primary completion
Dec 2018
Completion
Dec 2018
Last update
Jul 29, 2022

Study contacts

Gu Yanhong, PI
study chair · China:Jiangsu people's hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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