Endostatin Combined With Chemotherapy for Adjuvant Treatment of Esophageal Cancer

Study Overview
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Brief Summary
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This is an open-label, randomized trial, it compares the efficacy and safety between apatinib combined chemotheray and chemotherapy for adjuvant treatment of esophageal cancer

Official Title
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An Open-label, Randomized Clinical Trial of Recombinant Human Endostatin (Endo) Combined With Chemotherapy Compared With Chemotherapy for Adjuvant Treatment of Esophageal Cancer

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Nedaplatin
* Drug: Endostar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IIA-IIIC phase esophageal squamous cell carcinoma confirmed by histopathology and immunohistochemistry. R0 resection has been performed at least before 4 weeks. ECOG PS score: 0-1 points. Estimated survival time: at least 12 weeks. No radiotherapy, chemotherapy or molecular targeted therapy before. Main organs are functional, which meet the following criteria: Blood Routine: HB≥90 g/L（No blood transfusion within 14 days）, ANC≥1.5×109/L, PLT ≥80×109/L. Biochemical examination： ALB≥30g / L（No blood transfusion within 14 days）, ALT<2ULN； AST<2ULN TBIL≤1.5ULN； Plasma Cr≤1.5ULN； Volunteer with signed informed consent form, good compliance and good follow-up cooperation. Patients who the investigator believws they can benefit. Exclusion Criteria: Those who have had other malignant tumors in the past or at the same time. Pregnant or lactating women. Patients with grade-II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTC interval ≥ 450 ms) and cardiac dysfunction according to NYHA criteria III to IV. Cardiac color Doppler examination: LVEF (left ventricular ejection) Score) <50%. Have clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood ++), and a history of gastrointestinal bleeding within 6 months. Have a history of mental illness or psychotropic substance abuse. Patients who have participated in other drug clinical trials within 4 weeks. According to the investigator's judgment, patients who are at a risk or have accompanying disease. Patients who believe that they are unsuitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test Group 1<br>Docetaxel plus Nedaplatin combined with Endostar | Drug: Docetaxel<br>* 75mg/m2，3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles<br>Drug: Nedaplatin<br>* 80 mg/m2,3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles<br>Drug: Endostar<br>* 7.5mg/m2，once a day, continuously dosed for 14 days, then stop for 7 days,3 weeks for one cycle, totally 6 cycles<br>|
| Active Comparator: Test Group 2<br>Docetaxel plus Nedaplatin | Drug: Docetaxel<br>* 75mg/m2，3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles<br>Drug: Nedaplatin<br>* 80 mg/m2,3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles<br>|
| No Intervention: Control Group<br>No medicine intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 year disease-free survival rate | the percentage of the patients whose disease cannot be detected after curative therapy in three years | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | From the time of randomization to the time of death for any reason. | 3 years |