Liver transplant after SIRT and chemotherapy for locally advanced intrahepatic cholangiocarcinoma
Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After Selective Internal Radiotherapy With Labeled Yttrium and Chemotherapy: a Phase 2 Study
This trial tries to see if SIRT and chemotherapy followed by a liver transplant helps people with unresectable, non-metastatic intrahepatic cholangiocarcinoma live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Clichy-sous-Bois) |
| Trial ID | NCT06910722 on ClinicalTrials.gov |
What this trial studies
The trial will enroll 36 adults (18–65) with histologically confirmed, pauci-nodular (≤5 lesions) locally advanced intrahepatic cholangiocarcinoma without extrahepatic disease who are deemed technically unresectable. Participants receive selective internal radiation therapy (SIRT) plus gemcitabine and cisplatin chemotherapy to control or downstage tumors. Tumor response and absence of progression are checked with CT, liver MRI and PET-CT, and eligible patients undergo exploratory surgery before being listed for liver transplantation with a minimum waiting period of three months. Follow-up monitors liver graft function and tolerance/effectiveness of immunosuppressive therapy, with 3-year overall survival as the key outcome.
Who should consider this trial
Good fit: Adults aged 18–65 with histologically proven, uni- or pauci-nodular (≤5 lesions) intrahepatic cholangiocarcinoma that is unresectable but non-metastatic, WHO performance 0–1, and eligible for SIRT, gemcitabine+cisplatin and liver transplant are ideal candidates.
Not a fit: Patients with extrahepatic disease or lymph node involvement, tumor infiltrating >50% of the liver, advanced cirrhosis (≥Child B7), prior treatments for cholangiocarcinoma, or mixed/hepatocellular histology are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could improve 3-year overall survival and offer a potential curative option for a subset of patients with unresectable intrahepatic cholangiocarcinoma.
How similar studies have performed: Small series and case reports have suggested possible benefit of transplant after downstaging for highly selected intrahepatic cholangiocarcinoma patients, but randomized or large-scale evidence is lacking.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Clichy-sous-Bois
- Beaujon — Clichy-sous-Bois, France (Recruiting)
Study contacts
- Principal investigator: Mohamed Bouattour — Aphp
- Study coordinator: Mohamed BOUATTOUR
- Email: mohamed.bouattour@aphp.fr
- Phone: 1.40.87.56.14
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.