Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After Selective Internal Radiotherapy With Labeled Yttrium and Chemotherapy: a Phase 2 Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Strategy efficacy : 3 years overall survival
研究概览
简要总结
The study hypothesis is that liver transplantation after selective internal radiation therapy (SIRT) and chemotherapy would improve 3-year overall survival in patients with locally advanced (unresectable but non-metastatic) intrahepatic cholangiocarcinoma.
It is planned to include 36 patients with locally advanced intrahepatic cholangiocarcinoma, not eligible for initial surgery and without metastases. Participants will be recruited from care facilities in France.
详细描述
The hypothesis of the study is that liver transplantation after selective internal radiation therapy (SIRT) and chemotherapy would improve the overall 3-year survival of patients with locally advanced intrahepatic cholangiocarcinoma (unresectable but not metastatic).
All patients over 18 and under 65 years of age with histologically evidence, pauci-nodular (N≤5), locally advanced Intrahepatic cholangiocarcinoma (IHC) without extrahepatic involvement, considered technically unresectable by a panel of experts, eligible for treatment with SIRT, gemcitabine + cisplatin chemotherapy and Liver Transplant (LT).
Following treatment with SIRT + chemotherapy, tumor response or absence of tumor progression will be verified by a morphological workup combining CT-imaging, hepatic MRI and PET-CT.
After exploratory surgery to rule out any contraindications for LT, the patient will be list , with a minimum waiting of 3-month Follow-up will include assesment of Liver graft function, efficiency and tolerance of immunosuppressive therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 to 65
- •With histologically documented intrahepatic cholangiocarcinoma (primary diagnosis):
- •Uni or pauci nodular (≤ 5 lesions (all lesions are counted, even those less than 1 cm))
- •Without extrahepatic or lymph node involvement
- •Technically unresectable R0 according to an expert panel
- •Tumor target > 2 cm
- •free and informed consent signed
- •highly effective contraception for men and women of childbearing age during study participation up to 2 years post TH
排除标准
- •Extrahepatic, vesicular or perihilar cholangiocarcinoma
- •Tumor infiltration of more than 50% of the liver
- •Mixed cholangiocarcinoma, hepatocellular carcinoma, fibrolamellar carcinoma
- •Previous treatment for CCI
- •Cirrhosis ≥ Child B7
- •Chronic alcoholism
- •Uncontrolled chronic active infections (patients with HBV, HCV or HDV infections may be included if infections are controlled)
- •Stage III A, IIIB, IV and V chronic renal failure (glomerular filtration rate 59 ml/min)
- •Contraindications to liver transplant
- •Severe untreatable conditions
- •Recent history (less than 5 years) of cancer
- •severe comorbidities
- •Psychiatric or psychological disorders
- •Pregnant or breast-feeding women
- •Patient under guardianship
- •Not affiliated to a Health care system
- •Participating in another interventional study or within the exclusion period of a previous study involving the human body
研究组 & 干预措施
liver transplant patients
Liver transplantation performed after selective internal radiotherapy (SIRT) with Yttrium-90 and chemotherapy in patients with locally advanced (unresectable but non-metastatic) intrahepatic cholangiocarcinoma.
干预措施: Liver transplant (Procedure)
结局指标
主要结局
Strategy efficacy : 3 years overall survival
时间窗: 3 years post-transplant
To assess the 3-year overall survival of patients undergoing liver transplantation for stable or downstaged locally advanced intrahepatic cholangiocarcinoma after induction treatment with selective internal radiotherapy and chemotherapy.
次要结局
- Strategy feasibility 2/2 contraindication to transplantation(Liver transplantation)
- Strategy feasibility 1/2(Liver transplantation)
- therapeutic efficacy at 3 years(3 years after strategy implementation)
- Associated factors with the 3-years overall survival(3 years after strategy implementation)
- oncological prognosis1/2(after 8 courses of chemotherapy)
- therapeutic efficacy at 5 years(5 years after strategy implementation)
- oncological prognosis 2/2(5 years after strategy implementation)
- Histological response(1 year after strategy implementation)
- Tolerance of neoadjuvant treatment(after 8 courses of chemotherapy)
- quality of life monitoring(from induction therapy until 5 years post-transplant)
- Tolerance of global strategy(from induction therapy until 3 months post-transplant)