Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Liver transplant.
- Who it may be relevant to
- Registry conditions: Intrahepatic Cholangiocarcinoma, Locally Advanced Intrahepatic Cholangiocarcinoma. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After Selective Internal Radiotherapy With Labeled Yttrium and Chemotherapy: a Phase 2 Study
Overview
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.
Detailed description
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.
Interventions
- Procedure Liver transplant
follow-up of liver transplant patients after selective internal radiotherapy (SIRT) with Yttrium-90 and chemotherapy
Primary outcome measures
- Strategy efficacy : 3 years overall survival [Time frame: 3 years post-transplant]
Secondary outcome measures (11)
- Strategy feasibility 1/2 [Time frame: Liver transplantation]
- Strategy feasibility 2/2 contraindication to transplantation [Time frame: Liver transplantation]
- Associated factors with the 3-years overall survival [Time frame: 3 years after strategy implementation]
- therapeutic efficacy at 3 years [Time frame: 3 years after strategy implementation]
- therapeutic efficacy at 5 years [Time frame: 5 years after strategy implementation]
- oncological prognosis1/2 [Time frame: after 8 courses of chemotherapy]
- oncological prognosis 2/2 [Time frame: 5 years after strategy implementation]
- Histological response [Time frame: 1 year after strategy implementation]
- Tolerance of neoadjuvant treatment [Time frame: after 8 courses of chemotherapy]
- quality of life monitoring [Time frame: from induction therapy until 5 years post-transplant]
- Tolerance of global strategy [Time frame: from induction therapy until 3 months post-transplant]
Eligibility criteria
Inclusion criteria
- 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
- WHO 0-1
- free and informed consent signed
- highly effective contraception for men and women of childbearing age during study participation up to 2 years post TH
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
France · 1 center
- Beaujon — Clichy-sous-Bois
Identifiers
NCT: NCT06910722 · APHP220677