Spots Global Cancer Trial Database for XELOX Combined With Apatinib as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma

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Trial Identification

Brief Title: XELOX Combined With Apatinib as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma

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

Study ID: NCT03599778

Conditions

Gastric Carcinoma

Interventions

Apatinib

Study Description

Brief Summary: 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

Detailed Description: 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