Locally Advanced Gastric Carcinoma
Conditions
Brief 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.
Interventions
BIOLOGICALBevacizumab
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.
DRUGdocetaxel 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.
PROCEDUREGastrectomy
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed locally advanced adenocarcinoma of the stomach. * Age of 18 to 70, Karnofsky score higher than 80. * T3-4，N1-3，M0 (AJCC 7th), potentially resectable. * No severe functional damage of major organ, normal blood cell, normal liver and kidney function.
Exclusion criteria
* Clinical findings of distant metastasis or Peritoneal carcinomatosis * Prior systemic (chemo- or targeted) treatment. Prior radiotherapy to the upper abdomen * Previous malignancy within 5 years, with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer * Upper gastrointestinal bleeding * Any contraindication to treatment with docetaxel, 5-fu or oxaliplatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate | 6-12 weeks after administration |
Secondary
| Measure | Time frame |
|---|---|
| pCR rate | Day 1 after surgery |
| OS | 3 years after surgery |
| safety of peroperative treatment and surgery | from first administration to 28 days after last administration |
| DFS | 3 years after surgery |
| ORR | 6 weeks after administration |
Other
| Measure | Time frame | Description |
|---|---|---|
| circulating tumor cell number change | 6 weeks | to investigate the circulating tumor cell number change before and after neoadjuvant therapy and whether it's an effectiveness and survival predictor in LAGC |
Countries
China
Outcome results
None listed