Endostar Combined With MPFC Adjuvant Treatment of Esophageal Cancer Clinical Trial

NCT02749526 | Terminated Phase 2 DMC

• 1 other identifier: JS-ENDO-003
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophageal

Keywords

Recombinant human endostatin，Endo

Outcome Measures

Primary Outcomes (1)

• R0 Resection rate

  up to 8 months

Secondary Outcomes (1)

• pCR rate

  up to 10 months

Study Arms (1)

Endostar combined with MPFC

EXPERIMENTAL

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

"Endostar" DRUG

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

Endostar combined with MPFC

Liposo DRUG

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

Endostar combined with MPFC

cisplatin DRUG

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

Endostar combined with MPFC

Gimeracil and Oteracil Potassium （Tegafur） DRUG

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

Endostar combined with MPFC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Interventions

endostar protein; Cisplatin; gimeracil

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Gu Yanhong, PI

  China:Jiangsu people's hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: April 25, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)