Neoadjuvant Bev Plus DOF vs DOF in LAGC and Its Association With Circulating Tumor Cell
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
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.