NCT02048540

Neoadjuvant Bev Plus DOF vs DOF in LAGC and Its Association With Circulating Tumor Cell

Phase 2 Study of Neoadjuvant Bevacizumab Plus DOF Versus DOF in Local Advanced Gastric Carcinoma and Its Association With Circulating Tumor Cell

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Background Local advanced gastric carcinoma (LAGC) is suggested to be potentially cured by R0 resection, and neoadjuvant chemotherapy can increase the R0 resection rate but not enough. Bevacizumab (Bev), an anti-tumor angiogenesis monoclonal antibody, combined with chemotherapy has been shown effective in advanced GC. In addition, CTC has been suggested as an indicator of the anti-tumor drugs' efficacy. Therefore, in this study, the investigators plan to evaluate the efficacy and safety of neoadjuvant Bev plus docetaxel/oxaliplatin/5-FU/CF (DOF) versus DOF in mainly gastric antrum LAGC, and to investigate whether CTC is an effectiveness indicator. Methods 86 patients diagnosed as IIIb-IIIc GC have been enrolled and randomly assigned (1:1) to receive neoadjuvant Bev (5 mg/kg, d1) plus DOF (docetaxel, 75 mg/m2, iv, d1; oxaliplatin, 85 mg/m2, iv, d1; 5-FU, iv infusion 600 mg/m2 and iv injection 400mg/m2, d1-2; CF, 200 mg/m2, d1 and d2) or DOF each 3-week, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles. The primary endpoint is R0 resection rate. CTC was detected every 8 weeks. All patients signed the informed consent.

Conditions

• Locally Advanced Gastric Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Bevacizumab	Bev (5 mg/kg, d1) every 3 weeks, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles.
DRUG	docetaxel oxaliplatin 5-FU CF	docetaxel, 75 mg/m2, iv, d1; oxaliplatin, 85 mg/m2, iv, d1; 5-FU, iv infusion 600 mg/m2 and iv injection 400mg/m2, d1-2; CF, 200 mg/m2, d1 and d2 each 3-week, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles.
PROCEDURE	Gastrectomy

Timeline

• Start date: 2009-02-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2014-01-29
• Last updated: 2014-04-25

Locations

1 site across 1 country: China