Clinical trial · Interventional
Liver Transplantation for Early Intrahepatic Cholangiocarcinoma
Liver Transplantation for the Treatment of Early Stages of Intrahepatic Cholangiocarcinoma in Cirrhotics
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
Diagnosis of intrahepatic cholangiocarcinoma (iCCA) is increasingly common in patients with liver cirrhosis, but these patients are denied liver transplantation (LT) by most centres due to historically poor results. Two retrospective evaluations have shown a 5 year survival \~65% in selected patients with an iCCA diagnosis at the pathology of the explanted liver. This suggests that LT can be a curative treatment if applied selectively. This study will evaluate the effectiveness of LT as a treatment for very early iCCA diagnosed in cirrhotic patients who meet the strict selection criteria. Patients with advanced cirrhosis (not candidates for resection) currently have no other curative treatment options. Participants will be allowed bridging therapies prior to receiving transplant. Participants will be followed for 5 years from the time of transplant with patient survival and disease recurrence as outcome measures.
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 |
|---|---|---|---|
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Deceased donor Liver Transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Liver transplantation
- description
- The intervention will consist of liver transplantation
- interventionNames
- Procedure: Deceased donor Liver Transplantation
Primary outcomes (1)
- measure
- 5 year patient survival
- timeFrame
- 5 years
Secondary outcomes (1)
- measure
- disease recurrence after liver transplantation
- timeFrame
- 5 years
- description
- 5-years cumulative risk of recurrence after LT.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group: 0 or 1 at all times prior to Liver Transplantation * Absence of cancer-related symptoms * Liver cirrhosis (any etiology) * Patient not eligible for liver resection due to poor liver function/portal hypertension * Biopsy proven "very early" intrahepatic cholangiocarcinoma (iCCA) * Willing and able to provide written informed consent. * Negative serum pregnancy test for women of childbearing potential * Biopsy proven "very early" (single ≤2 cm) iCCa * No vascular or biliary involvement seen in preoperative imaging * No extra-hepatic disease seen in preoperative imaging * Carbohydrate Antigen (CA) 19.9 values are ≤100 ng/mL Exclusion Criteria: * Previous or concurrent cancer (with some exceptions) * Patients that have had previous liver resection for iCCA and the current tumor is a recurrence. * Progression of the tumor in size \>3 cm or development of extrahepatic disease. * Large vessel invasion, defined radiologically. * Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min * Pulmonary insufficiency * History of cardiac disease: * Uncontrolled infection(s) * Known history of human immunodeficiency virus (HIV) infection. * History of solid organ transplantation * Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study * Pregnant or breast-feeding patients
References
Publications (2)
- BACKGROUNDSapisochin G, Facciuto M, Rubbia-Brandt L, Marti J, Mehta N, Yao FY, Vibert E, Cherqui D, Grant DR, Hernandez-Alejandro R, Dale CH, Cucchetti A, Pinna A, Hwang S, Lee SG, Agopian VG, Busuttil RW, Rizvi S, Heimbach JK, Montenovo M, Reyes J, Cesaretti M, Soubrane O, Reichman T, Seal J, Kim PT, Klintmalm G, Sposito C, Mazzaferro V, Dutkowski P, Clavien PA, Toso C, Majno P, Kneteman N, Saunders C, Bruix J; iCCA International Consortium. Liver transplantation for "very early" intrahepatic cholangiocarcinoma: International retrospective study supporting a prospective assessment. Hepatology. 2016 Oct;64(4):1178-88. doi: 10.1002/hep.28744. Epub 2016 Aug 24. PMID 27481548
- DERIVEDAchurra P, Fernandes E, O'Kane G, Grant R, Cattral M, Sapisochin G. Liver transplantation for intrahepatic cholangiocarcinoma: who, when and how. Curr Opin Organ Transplant. 2024 Apr 1;29(2):161-171. doi: 10.1097/MOT.0000000000001136. Epub 2024 Jan 23. PMID 38258823