Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy

NCT06910722 | Not Yet Recruiting DMC

• 1 other identifier: APHP220677
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Transplantation in Locally Advanced Intrahepatic Cholangiocarcinoma

Keywords

liver transplantation; locally advanced intrahepatic cholangiocarcinoma; selective internal radiation therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years post-transplant

Secondary Outcomes (11)

• Strategy feasibility 1/2

  Liver transplantation

• Strategy feasibility 2/2 contraindication to transplantation

  Liver transplantation

• Associated factors with the 3-years overall survival

  3 years after strategy implementation

• therapeutic efficacy at 3 years

  3 years after strategy implementation

• therapeutic efficacy at 5 years

  5 years after strategy implementation

Study Arms (1)

liver transplant patients

EXPERIMENTAL

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

Procedure: Liver transplant

Interventions

Liver transplant PROCEDURE

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

liver transplant patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Interventions

Liver Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Mohamed Bouattour

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed BOUATTOUR

CONTACT

1.40.87.56.14; mohamed.bouattour@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2030
• Last Updated: April 4, 2025

Record last verified: 2025-03