A Phase III, Multicenter, Open-Label, Randomized Study of Cisplatin or Carboplatin With Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Patients With Resected or Ablated Intra-Hepatic Cholangiocarcinoma
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
Compare the efficacy of adjuvant chemotherapy with Cisplatin or Carboplatin and Gemcitabine versus Gemcitabine in patients with resected or ablated intra-hepatic cholangiocarcinoma.
详细描述
Phase III, multicenter, open label, randomized study of Cisplatin or Carboplatin with Gemcitabine versus Gemcitabine alone as adjuvant therapy in patients with resected or ablated intra-hepatic cholangiocarcinoma. Subjects will be randomized in a 1:1 fashion to Cisplatin or Carboplatin with Gemcitabine versus Gemcitabine alone.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age, of any race or sex who are eligible to sign written consent and have undergone prior resection of histological evidence of intrahepatic cholangiocarcinoma
- •Hematologic function: ANC ≥ 1.5 x 10 /L, platelets ≥ 75 x 10 /L, and hemoglobin > 9 g/dL
- •Adequate liver function as measured by: total bilirubin ≤ 2.0 mg/dl, AST and ALT ≤ 5 ULN, albumin ≥ 2.5 g/dl
- •Adequate renal function as measured by: creatinine ≤ 2.9 mg/dl, > 50 ml/min calculated by the C-G equation
- •Non-pregnant women of child bearing potential and fertile men are required to use effective contraception (negative pregnancy test for women of child-bearing age)
- •ECOG status ≤ 1 at screening
排除标准
- •Subjects will be eligible for the study if they meet all inclusion criteria
研究组 & 干预措施
Arm A
Cisplatin or Carboplatin with Gemcitabine for 6 cycles
干预措施: Carboplatin (Drug)
Arm A
Cisplatin or Carboplatin with Gemcitabine for 6 cycles
干预措施: Cisplatin (Drug)
Arm A
Cisplatin or Carboplatin with Gemcitabine for 6 cycles
干预措施: Gemcitabine (Drug)
Arm B
Gemcitabine alone for 6 cycles
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall Survival
时间窗: Every three months for 4 years
次要结局
- Progression Free Survival(Every three months for 4 years.)
研究者
Robert C. Martin
Principal Investigator
University of Louisville