About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged 18 to 65
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
Disqualifiers
Extrahepatic, vesicular or perihilar cholangiocarcinoma
Tumor infiltration of more than 50% of the liver
Mixed cholangiocarcinoma, hepatocellular carcinoma, fibrolamellar carcinoma
Previous treatment for CCI
Trial design
Single group
Treatments tested in this trial
Liver transplant
Procedure/Surgeryfollow-up of liver transplant patients after selective internal radiotherapy (SIRT) with Yttrium-90 and chemotherapy
Treatment groups
Trial outcomes
Primary outcomes
Strategy efficacy : 3 years overall survival
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.
Secondary outcomes
Strategy feasibility 1/2
Number of patients benefiting from the complete strategy implemented
Strategy feasibility 2/2 contraindication to transplantation
Number of patients with radiological tumor progression according to RECIST 1.1 criteria after neoadjuvant treatment contraindicating transplantation
Associated factors with the 3-years overall survival
Socio-demographic and clinico-radio-biological characteristics at baseline and follow-up of living patients 3 years after strategy implementation.
therapeutic efficacy at 3 years
Number of transplant patients alive and free of recurrence at 3 years after strategy implementation, as well as their socio-demographic and clinico-radiobiological characteristics at baseline and follow-up.
Sponsors and contacts
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