Systemic Chemotherapy Based on Oxaliplatin and 5-fluorouracil Plus PD-1 for Metastasis ICC-single Arm Prospective Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Progression free survival rate of 6 months
研究概览
简要总结
This study were designed to verify the better method of survival for metastatic ICC.
Since the traditional method for metastatic ICC was GEMOX(recommended from NCCN guideline), our previous study found better results from Folfirinox over GEMOX.
Our current study were conducted for further investigation to verify the better method for metastatic ICC.
详细描述
ICC(Intrahepatic CholangioCarcinoma) patients with metastasis has a short survival time and poor prognosis after diagnosis. Treatment methods was few and far from satisfaction. The treatment recommended from NCCN guideline was GEMOX(Systemic Chemotheray) and clinical trials. Our previous study has demonstrate Folfirinox(Systemic Chemotheray based on Oxaliplatin，5-fluorouracil and Irinotecan) has a survival and tumor response advantage of GEMOX.
Further study was needed to intensive confirmation of the result. We designed this study to demonstrate the hypothesis. Metastasis ICCs were recruited and screened by our criteria. All patients were treated with Folfirinox(Systemic Chemotheray based on Oxaliplatin，5-fluorouracil and Irinotecan) plus PD1(Sintilimab).
The progression free survival and overall survival were our primary and secondary endpoint.
Our study were designed to verify the better method of survival for metastatic ICC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •With distant metastasis
- •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
- •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.
研究组 & 干预措施
Folfirinox plus PD1
Patients treated with systemic chemotherapy(regimen: Folfirinox) plus PD1
干预措施: Folfirinox (Drug)
Folfirinox plus PD1
Patients treated with systemic chemotherapy(regimen: Folfirinox) plus PD1
干预措施: Sintilimab (Drug)
结局指标
主要结局
Progression free survival rate of 6 months
时间窗: 6 months
Ratio of patients observed progression of tumor at 6 months
次要结局
- Overall survival(6 months)
- Number of adverse events(30 days)
研究者
Shi Ming
Professor
Sun Yat-sen University