A Phase 1/2 interventional study of Bevacizumab and docetaxel oxaliplatin 5-FU CF in Locally Advanced Gastric Carcinoma, sponsored by Chinese PLA General Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-04-25.
Sponsored by Chinese PLA General Hospital · Phase 1/2, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 86 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients receive bev +DOF pre and post surgery up to total 6 cycles
Biological: Bevacizumab · Drug: docetaxel oxaliplatin 5-FU CF · Procedure: Gastrectomy
patients receive DOF pre and post surgery up to total 6 cycles
Drug: docetaxel oxaliplatin 5-FU CF · Procedure: Gastrectomy
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.
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.
R0 resection rate
Time frame: 6-12 weeks after administration
pCR rate
Time frame: Day 1 after surgery
OS
Time frame: 3 years after surgery
DFS
Time frame: 3 years after surgery
ORR
Time frame: 6 weeks after administration
safety of peroperative treatment and surgery
Time frame: from first administration to 28 days after last administration
circulating tumor cell number change
to investigate the circulating tumor cell number change before and after neoadjuvant therapy and whether it's an effectiveness and survival predictor in LAGC
Time frame: 6 weeks
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Chinese PLA General Hospital