Gastric Carcinoma Clinical Trial
Official title:
A Phase I/II Clinical Study to Compare Postoperative Chemotherapy of Oxaliplatin With Capecitabine(XELOX)Combined With APATINIB as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma With D2 Dissection
To observe and evaluate the efficacy and safety of oxaliplatin with oapecitabine(XELOX)combined with apatinib as post-operative chemotherapy in locally advanced gastric adenocarcinoma with D2 dissection
Stage 1 (phase I tolerance study) : 12 patients were enrolled in the dose-climbing
study:According to the principle of dose-climbing test,todetermine the subjects' MTD, with
the following three dose levels:
- Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib 250
mg, qd x180d; ②. Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w)
+ apatinib 375 mg, qd x180d; ③. Capecitabine: 1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130
mg/m2 d1 q3w) + apatinib 500 mg, qd x180d;
Stage 2 (phase II exploratory study) :
①.Test group: subjects received 8 cycles of postoperative XELOX regimen (capecitabine: 1000
mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w) + apatinib maximum tolerated dose
②.Control group: Subjects received 8 cycles of XELOX regimen after surgery (capecitabine:
1000 mg/m2 bid d1-14 q3w, oxaliplatin: 130 mg/m2 d1 q3w).
Eligible patients will receive 8 cycles of postoperative adjuvant therapy and will be
followed up to death
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