奥沙利铂治疗结直肠癌的随机多中心Ⅱ期临床试验

A multicenter randomized phase Ⅱ trail of Oxaliplatin in the patients with colorectal cancer

Objective: To evaluate the efficacy and safety of Oxaliplatin in the patients with colorectal cancer. Methods: In a multicenter randomized control study, a total of 144 patients were divided into four groups: Oxaliplatin (Haitong) 5-FU, CF(group A) 41 cases; 5-FU CF (group B) 41 cases; Oxaliplatin (Haitong) 5-FU, CF (group C) 31 cases; Oxaliplatin (positive drug) 5-FU CF (group D) 31 cases. Oxaliplatin combination regimen: L-OHP 130 mg/m2 i.v. infusion 2 h d1; CF 200 mg/m2i.v. 2h d1-d5; 5-FU 300 mg/m2 i.v. infusion 4h d1-d5 (after CF). 5-FU CF combination regimen: CF 200 mg/m2 i.v. infusion 2 h d1-d5, 5-FU 300 mg/m2 i.v. infusion 4h d1-d5 (after CF), the schedule was repeated every 3 weeks. The total cycles were 3. Results: After three circles treatment, overall response rate of 4 groups was 24.4% (group A), 2.4% (group B), 25.8%(group C) and 19.4% (group D), respectively. The response rate was significantiy different between group A and group B (P＜0.01), but no significant difference was observed between group C and group D (P＞0.05). Conclusion: The Oxaliplatin(Haitong) for injection combination regimen is effective in the treatment of colorectal cancer.