Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy

NCT ID: NCT06910722

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2030-04-01

Brief 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.

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.

Conditions

Liver Transplantation in Locally Advanced Intrahepatic Cholangiocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

liver transplant patients

Liver transplantation performed after selective internal radiotherapy (SIRT) with Yttrium-90 and chemotherapy in patients with locally advanced (unresectable but non-metastatic) intrahepatic cholangiocarcinoma.

Group Type: EXPERIMENTAL

Liver transplant

Intervention Type: PROCEDURE

follow-up of liver transplant patients after selective internal radiotherapy (SIRT) with Yttrium-90 and chemotherapy

Interventions

Liver transplant

follow-up of liver transplant patients after selective internal radiotherapy (SIRT) with Yttrium-90 and chemotherapy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed Bouattour

Role: PRINCIPAL_INVESTIGATOR

APHP

Central Contacts

Mohamed BOUATTOUR

Role: CONTACT

mohamed.bouattour@aphp.fr

1.40.87.56.14 ext. +33

Other Identifiers

APHP220677

Identifier Type: -

Identifier Source: org_study_id