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Clinical Trial 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


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03599778
Study type Interventional
Source Anhui Provincial Hospital
Contact Xinyang He, master
Phone 13505518319
Email HXY2333@126.com
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date September 1, 2018
Completion date January 30, 2025

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