Oxaliplatin Plus Gemcitabine Versus Capecitabine Alone as Adjuvant Treatment in the Prevention of Recurrence of Intrahepatic Cholangiocarcinoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- Recurrence-free survival
研究概览
简要总结
To evaluate of adjuvant therapy using oxaliplatin and gemcitabine (GEMOX regimen) versus capecitabine alone chemotherapy in patients who underwent curative surgery for intrahepatic cholangiocarcinoma (ICC) -- a randomized control study.
详细描述
chemotherapy: GEMOX vs capecitabine alone; adjuvant settings; primary endpoint: recurrence-free survival (RFS); second endpoint: overall survival after surgery (OS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG PS≤1;
- •pathologically confirmed adenocarcinoma of bile duct;
- •R1 resection or R0 resection with these risk factors: lymph node metastasis, lymphatic vessel or blood vessel invasion, multiple tumors, tumor size >5 cm, preoperative CA199>200 U/mL.
- •postoperative liver function Child Pugh Class A, leukocyte count>1.5*10^9/L, platelet count>100*10^9/L, serum alanine aminotransferase <1.5*ULN
- •no tumor recurrence or metastasis on baseline examination
- •no history of radiotherapy or intervention therapy
排除标准
- •hepatocellular carcinoma, mixed carcinoma of ICC and HCC, or hilar cholangiocarcinoma
- •distant metastasis
- •prothrombin time >14s
- •severe cardiopulmonary dysfunction
- •severe renal dysfunction
- •bone marrow suppression before the initiation of therapy
- •allergic to fluorouracil, gemcitabine, or platinum
- •gemcitabine was used in combination with radiotherapy
研究组 & 干预措施
Capecitabine
capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.
干预措施: capecitabine (Drug)
GEMOX
oxaliplatin and gemcitabine (GEMOX regimen): day 1: oxaliplatin 85 mg/m2, gemcitabine 1000 mg/m2; day 8: gemcitabine 1000 mg/m2; every three weeks for 6-8 cycles in total.
干预措施: oxaliplatin and gemcitabine (Drug)
结局指标
主要结局
Recurrence-free survival
时间窗: from the date of surgery to the date of tumor recurrence up to 36 months after surgery
次要结局
- Overall survival(from the date of surgery to the date of death up to 36 months after surgery)
研究者
Hui-Chuan Sun
Vice Director of the Department of Liver Surgery
Shanghai Zhongshan Hospital