A multi-center, non-random, open study ,to observe efficacy and safety of bevacizumab plus Oxaliplatin based multidrug chemotherapy as conversion therapy for patients with previously untreated unresectable liver metastases from colorectal cancer.
PRIMARY OBJECTIVES:To assess the objective response rate(ORR)(8 weeks after chemotherapy) SECONDARY OBJECTIVES: 1. To assess the R0 resection rate of liver metastases(8 weeks after chemotherapy、every three months follow-up 1 time in R0 postoperative 1-2 years、Every six months follow-up 1 time in R0 postoperative 2-5 years) 2. To assess the incidence of adverse events of level 3-4 (Bleeding、Gastrointestinal Perforation、Anastomotic Fistula、Hypertension、Wound Healing Delay)(8 weeks after chemotherapy)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
1. Bevacizumab: 7.5mg/kg, iv, on day 1 of each 21 day cycle or 5mg/kg, iv, on day 1 of each 14 day cycle; 2. Oxaliplatin+capecitabine(XELOX):( The total dose not less than 70% of the recommended dose of this standard) Oxaliplatin: 130mg/m2,d1; capecitabine: 850-1,000mg/m2,d1-d14, bid,each 21 day cycle; 3. Oxaliplatin+5-Fluorouracil+ Levomisole(FOLFOX): Oxaliplatin: 85mg/m2,iv for 2 hours ,d1; Levomisole(LV): 400mg/m2,iv for 2 hours,d1; 5-Fluorouracil(5-FU) :400mg/m2 iv,d1,then 1200mg/m2/d ×2d continuous intravenous infusion(volume dose:2400mg/m2,iv for 46-48 hours ) each 14 day cycle;
Second Affiliated Hosptial of Harbin Medical University
Harbin, Heilongjiang, China
Liaoning Cancer Hospital&Institute
Shenyang, Liaoning, China
To assess the objective response rate(ORR)
Time frame: 8 weeks after chemotherapy
To assess the R0 resection rate of liver metastases
Time frame: 8 weeks after chemotherapy、every three months follow-up 1 time in R0 postoperative 1-2 years、Every six months follow-up 1 time in R0 postoperative 2-5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.