Clinical trial · Interventional
Liver Resection Versus Radio-chemotherapy-Transplantation for Hilar Cholangiocarcinoma
Randomized Prospective Multicentric Study: Radio-chemotherapy and Liver Transplantation Versus Liver Resection to Treat Respectable Hilar Cholangiocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A prospective, open-label, randomised, multicentre, comparative study in two parallel groups comparing an interventional group with liver transplantation preceded by neoadjuvant radio-chemotherapy and a control group receiving conventional liver and bile duct resection. The primary endpoint will be overall survival at 5 years in the intent-to-treat population. The secondary endpoint will be recurrence-free survival at 3 years evaluated by CT-scan and tumoral markers (Carcinoembryonic antigen (CAE) and cancer antigen (CA19.9)) in the intent-to-treat population. The number of subjects necessary is 54 patients (27 x 2): this population will enable the demonstration of a significant difference is 5-year survival rates between the transplanted group and the resected group with a power of 80% and a first-species risk of 5%, under the hypothesis that these survival rates are 70% in the transplanted group and 30% in the resected group.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAPECITABINE-Radiotherapy -Liver Transplantation | Procedure | — | UNRESOLVED |
| RESECTION | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CAPECITABINE-Radiotherapy -Liver Transplantation
- description
- Neoadjuvant Radio-Chemotherapy (RC) and Liver Transplantation (LT)
- interventionNames
- Procedure: CAPECITABINE-Radiotherapy -Liver Transplantation
- type
- ACTIVE_COMPARATOR
- label
- RESECTION
- description
- Liver resection
- interventionNames
- Procedure: RESECTION
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- At 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 68 Years
Show eligibility criteria text
Inclusion Criteria: * Patients (male or female) aged from 18 to 68 year-old, French * Hilar cholangiocarcinoma histologically proved and/or highly suspected on hilar stenosis with mass syndrome from 0.1 cm to 3 cm * Hilar cholangiocarcinoma type 2, type 3A, type 3B, type 4 * Patients considered as resectable (R0 resection) by liver resection including segment 1 and biliary confluence with or without vascular resection * Patient potentially transplantable * Patient affiliated to French Health Insurance * Patient who had sign an informed consent Exclusion Criteria: * Pregnant or breastfeeding woman * Women of childbearing potential without an effective contraception method * Radiotherapy contraindication * Positive dosage of ImmunoglobulinsG4 (IgG4) * dihydro-pyrimidine-dehydrogenase (DPD) total deficit * Personal history of cancer in the last 5 five years (exclusion basocellular cellular carcinoma) * Personal history of fluoropyrimidine hypersensibility * Personal history of capecitabine hypersensibility * Personal history of dihydro-pyrimidine-dehydrogenase deficit * Polynuclear neutrophil \< 1500 / ml * Platelet rate \< 100 000 / ml * Severe leucopenia \< 2000 / ml * Severe liver failure (Factor V \< 50%) * Severe renal failure (Creatin clearance \< 30 ml/min) * Treatment by Sorivudine or its analogue as Brivudine * Non controled diabetes mellitus and/or others severe co-morbidities (renal failure, severe and instable coronaropathy, severe risk factor of stroke, body mass index superior to 35) * Proved histological cirrhosis * Sclerosing cholangitis * Intra and/or extra-hepatic metastases * Hypereosinophilia and/or wirsung dilatation and/or mass of the pancreas head * Hilar mass superior to 3 cm * Duodenal invasion * Patient under guardianship
References
Publications (0)
Data not yet available