Esophageal Cancer
Conditions
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
Interventions
DRUGDocetaxel
75mg/m2，3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles
DRUGNedaplatin
80 mg/m2,3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles
DRUGEndostar
7.5mg/m2，once a day, continuously dosed for 14 days, then stop for 7 days,3 weeks for one cycle, totally 6 cycles
Sponsors
First Affiliated Hospital of Guangxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 3 years | From the time of randomization to the time of death for any reason. |
Outcome results
None listed