Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemoth… (NCT06910722) | Clinical Trial Compass
RecruitingNot Applicable
Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy
France36 participantsStarted 2025-08-28
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.