NCT06910722Recruiting
Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy
Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After Selective Internal Radiotherapy With Labeled Yttrium and Chemotherapy: a Phase 2 Study
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 28 Mar 2025
- Start date
- 28 Aug 2025
- Primary completion date
- 28 Aug 2028
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06910722
What you commit to
- Study type: Interventional
- Planned participants: 36
- From 28 Aug 2025 to the primary completion date, 28 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment for CCI
- Participating in another interventional study or within the exclusion period of a previous study involving the human body
Other illness
- 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
Other
- Extrahepatic, vesicular or perihilar cholangiocarcinoma
- Tumor infiltration of more than 50% of the liver
- Mixed cholangiocarcinoma, hepatocellular carcinoma, fibrolamellar carcinoma
- Cirrhosis ≥ Child B7
- Chronic alcoholism
- Pregnant or breast-feeding women
- Patient under guardianship
- Not affiliated to a Health care system
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beaujon Coordinator of this site? Confirm its status | Clichy-sous-Bois | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.