Hepatic Arterial Infusion Chemotherapy of Irinotecan, Oxaliplatin, 5-Fluorouracil and Leucovorin Versus Systemic Chemotherapy of Gemcitabine and Oxaliplatin for Unresectable Intrahepatic Cholangiocarcinoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of irinotecan, oxaliplatin, 5-fluorouracil and leucovorin compared systemic chemotherapy of gemcitabine and oxaliplatin in patients with unresectable intrahepatic cholangiocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of ICC
- •Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
- •With no previous treatment
- •No Cirrhosis or cirrhotic status of Child-Pugh class A only
- •Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
- •Without distant metastasis, but intrahepatic lymph node metastasis is allowed
- •The following laboratory parameters:
- •Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
排除标准
- •Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- •Known history of HIV
- •History of organ allograft
- •Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- •Evidence of bleeding diathesis.
- •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- •Known central nervous system tumors including metastatic brain disease
研究组 & 干预措施
Hepatic artery infusion chemotherapy
Participants received hepatic artery infusion chemotherapy of irinotecan, oxaliplatin, 5-fluorouracil and leucovorin
干预措施: irinotecan, oxaliplatin , fluorouracil, and leucovorin (Drug)
Systemic chemotherapy
Participants received systemic chemotherapy of gemcitabine and oxaliplatin
干预措施: gemcitabine and oxaliplatin (Drug)
结局指标
主要结局
Overall survival
时间窗: 12 months
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
次要结局
- Time to progression(12 months)
- Number of adverse events.(30 days)
- Progression free survival(12 months)
研究者
Shi Ming
Proffessor
Sun Yat-sen University