Endostatin Combined With Chemotherapy for Adjuvant Treatment of Esophageal Cancer
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Test Group 1 Docetaxel plus Nedaplatin combined with Endostar |
Drug: Docetaxel
75mg/m2，3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles
Drug: Nedaplatin
80 mg/m2,3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles
Drug: Endostar
7.5mg/m2，once a day, continuously dosed for 14 days, then stop for 7 days,3 weeks for one cycle, totally 6 cycles
|
| Active Comparator: Test Group 2 Docetaxel plus Nedaplatin |
Drug: Docetaxel
75mg/m2，3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles
Drug: Nedaplatin
80 mg/m2,3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles
|
| No Intervention: Control Group No medicine intervention |
Outcome Measures
Primary Outcome Measures
- 3 year disease-free survival rate [3 years]
the percentage of the patients whose disease cannot be detected after curative therapy in three years
Secondary Outcome Measures
- overall survival [3 years]
From the time of randomization to the time of death for any reason.
Eligibility Criteria
Criteria
Inclusion Criteria:
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IIA-IIIC phase esophageal squamous cell carcinoma confirmed by histopathology and immunohistochemistry.
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R0 resection has been performed at least before 4 weeks.
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ECOG PS score: 0-1 points.
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Estimated survival time: at least 12 weeks.
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No radiotherapy, chemotherapy or molecular targeted therapy before.
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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；
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Volunteer with signed informed consent form, good compliance and good follow-up cooperation.
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Patients who the investigator believws they can benefit.
Exclusion Criteria:
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Those who have had other malignant tumors in the past or at the same time.
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Pregnant or lactating women.
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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%.
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Have clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood ++), and a history of gastrointestinal bleeding within 6 months.
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Have a history of mental illness or psychotropic substance abuse.
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Patients who have participated in other drug clinical trials within 4 weeks.
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According to the investigator's judgment, patients who are at a risk or have accompanying disease.
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Patients who believe that they are unsuitable for inclusion.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- First Affiliated Hospital of Guangxi Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HRGX06