DRKS00000805招募中2 期
Feasibility and efficacy of adjuvant gemcitabine chemotherapy after liver transplantation for proximal bile duct cancer - pro-duct 001
Charité Campus Virchow-Klinikum0 个研究点目标入组 60 人开始时间: 2012年10月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Listing for liver transplantation:
- •diagnosis of hilar cholangiocarcinoma
- •tumor not curatively resectable
- •obligatory staging laparotomy with diagnostic lymphadenectomy and histologic confirmation of negative lymph nodes
- •negative pregnancy test
- •informed consent
- •Randomization for adjuvant chemotherapy:
- •liver transplantation within three months after listing for liver transplantation
- •histologically proven proximal bile duct cancer
- •curative resection of the tumor (R0)
- •CT scan of the chest not older than 8 weeks before randomization showing no detectable distant metastases
- •possibility to start adjuvant chemotherapy between 4 and 10 weeks after liver transplantation
- •sufficient bone marrow function (WBC > 3.5/nl, platelets > 80/nl, hemoglobin > 8 g/dl)
- •sufficient renal function (creatinin clearance = 30 ml/min)
- •sufficient liver function (bilirubin < 3 mg/dl)
排除标准
- •Listing for liver transplantation:
- •locally very advanced, irresectable tumor infiltrating adjacent other organs, the main trunk of the hepatic artery
- •a visible tumor mass on CT or MRI scan larger than 3 cm in diameter
- •CA 19-9 levels > 1000 U/ml
- •tumors suspicious for gallbladder cancer
- •known lymph node or distant metastasis
- •patients undergoing multi-organ transplantation or have undergone previous solid organ or bone marrow transplantation
- •previous or intended photodynamic therapy, radiation, chemotherapy, brachytherapy
- •previous tumor biopsy (except via ERC)
- •previous completed or attempted surgery for hilar cholangiocarcinoma
- •patients with known hypersensibility for gemcitabine
- •pregnancy or breastfeeding
- •general contraindications for liver transplantation
- •HIV infection
- •Randomization for adjuvant chemotherapy:
- •patients with biliary sepsis, intrahepatic abscesses or other complications (e.g. severe liver dysfunction) contraindicating adjuvant chemotherapy
- •contraindications against study medication (including auxiliary substances)
- •pregnancy or breastfeeding
- •therapy with mTOR-inhibitors (sirolimus, everolimus)
- •any clinically significant medical or surgical condition, that in the investigator`s opinion would preclude adjuvant chemotherapy
- •participitation in other clinical trials
研究者
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