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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Locally Advanced Gastric Carcinoma

Treatments: Biological: Bevacizumab; Procedure: Gastrectomy; Drug: docetaxel oxaliplatin 5-FU CF

Study type: Interventional

Funder types: Other

Identifiers

NCT02048540

GC neoadjuvant bev CTC

BSC2013-dunan (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

bevacizumab plus DOF

Experimental group

Description:

patients receive bev +DOF pre and post surgery up to total 6 cycles

Treatment:

Drug: docetaxel oxaliplatin 5-FU CF

Biological: Bevacizumab

Procedure: Gastrectomy

DOF

Active Comparator group

Description:

patients receive DOF pre and post surgery up to total 6 cycles

Treatment:

Drug: docetaxel oxaliplatin 5-FU CF

Procedure: Gastrectomy