阿托氟啶治疗晚期消化道肿瘤Ⅱ期临床研究

PhaseⅡ clinical trial of A-OT-FU in Patients with advanced digestic carcinomas

目的 :评价口服国产阿托氟啶单药及联合方案治疗无法手术或手术后复发、转移的晚期胃癌、肝癌、食管癌和大肠癌的疗效及其毒副反应。方法 :收治晚期消化道肿瘤患者 4 7例 ,随机分组 :单药组 15例 (单用阿托氟啶 )、联合化疗组 2 3例 (用阿托氟啶联合化疗 )以及对照组 9例 (用FT2 0 7联合化疗 )。结果 :单药组有效率 6 6 7% ,联合化疗组 13 0 4 % ,对照组0 %。无严重毒副反应。单药组及治疗组疗效高于对照组。结论 :口服国产阿托氟啶单用或联合治疗对晚期消化道肿瘤疗效肯定 ,毒副反应较小 。

Objective:To evaluate the effect and toxicities of domestic made A OT FU in patients with advanced digestic carcinomas.Methods:47 cases were randomized into three groups. 23 patients in drug combination group (A OT FU combination the other chemotherapy drugs) 9 patients in control group (FT207 combination the other chemotherapy drugs).Results:The response rate was 6 67% in single drug group, 13 4% in drug combination group, and 0% in control group. The response rates in both single drug group and drug combination group were superior to that in control group. The three groups were not severe toxicity.Conclusion:The domestic made A OT FU is effective in patients with advanced digestic carcinoma when used alone or combinated with the other chemotherapy drugs, and well tolerant. It is valuble to give further study in clinical research and practive in future.