Clinical trial · Interventional
Living Donor Liver Transplantation for Intrahepatic Cholangiocarcinoma
Living Donor Liver Transplantation for Neoadjuvant Treated, Unresectable Intrahepatic Cholangiocarcinoma
NCT06539377CI-TRIAL-00079481LIVINCAnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study is supposed to make liver transplantation available for treatment in well selected patients suffering from non-resectable intrahepatic cholangiocarcinoma. Donor organ shortage is currently the main problem for organ transplantation world-wide. Thus, the particular indication "non-resectable intrahepatic cholangiocarcinoma" is currently excluded in terms of transplantation. Given those circumstances, transplantation via living donation might be the best option. This procedure does not reduce the deceased donor organ supply because living donation is the primary treatment option in these patients (not subsidiary).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Transplantation | — | UNRESOLVED | — |
| Living Donor Liver Transplantation | — | UNRESOLVED | — |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Living donor liver transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Living donor liver transplantation
- description
- The evaluation tests prior the transplantation will be performed following the standard protocol for the evaluation of a waiting list applicants prior liver transplantation. The aim of this procedure is to rule out any significant co-morbidities (e.g. cardiologic diseases, other malignancies) which would preclude liver transplantation. After successful evaluation of the recipient and waiting list registration with Eurotransplant, the AB0-compatible donor will be evaluated as well according to a center-specific protocol. For a local control of the tumor, an additional local-ablative therapy (SIRT) is mandatory.
- interventionNames
- Procedure: Living donor liver transplantation
Primary outcomes (1)
- measure
- Five year overall survival
- timeFrame
- Five years
- description
- Survival from time of transplantation to time of death or last follow up
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * non-resectable intrahepatic cholangiocarcinoma (either for localization / distribution of the carcinoma or for estimated function of the liver in case of liver fibrosis / cirrhosis) * biopsy proven grading G1 / G2 * in case of mixed hepatocellular carcinoma / cholangiocarcinoma, the cholangiocarcinoma also must have a grading of G1 / G2 * response to chemotherapy in terms of stable or regressive disease (imaging studies, tumor marker CA19-9, any chemotherapy regime allowed, a local-ablative therapy in means of a SIRT is mandatory * peritoneal carcinosis / extrahepatic spread ruled out in PET-CT and/or MRT/CT and, at latest, during exploration * age ≥ 18 * blood-group compatible living donor available * in female patients: negative pregnancy test * written informed consent before study enrolment of donor and recipient (all other procedures are clinical routine procedures in the management of these patients) Exclusion Criteria: * extrahepatic tumor/metastases * G3 tumors * progress under neoadjuvant treatment according to the RECIST-criteria * pregnancy or breastfeeding * patients unwilling to consent to saving and propagation of pseudonymized medical data for study reasons * general contraindications for liver transplantation
References
Publications (5)
- BACKGROUNDGoldaracena N, Gorgen A, Sapisochin G. Current status of liver transplantation for cholangiocarcinoma. Liver Transpl. 2018 Feb;24(2):294-303. doi: 10.1002/lt.24955. PMID 29024405
- BACKGROUNDZiogas IA, Giannis D, Economopoulos KP, Hayat MH, Montenovo MI, Matsuoka LK, Alexopoulos SP. Liver Transplantation for Intrahepatic Cholangiocarcinoma: A Meta-analysis and Meta-regression of Survival Rates. Transplantation. 2021 Oct 1;105(10):2263-2271. doi: 10.1097/TP.0000000000003539. PMID 33196623
- BACKGROUNDChan KM, Tsai CY, Yeh CN, Yeh TS, Lee WC, Jan YY, Chen MF. Characterization of intrahepatic cholangiocarcinoma after curative resection: outcome, prognostic factor, and recurrence. BMC Gastroenterol. 2018 Dec 4;18(1):180. doi: 10.1186/s12876-018-0912-x. PMID 30514231
- BACKGROUNDLunsford KE, Javle M, Heyne K, Shroff RT, Abdel-Wahab R, Gupta N, Mobley CM, Saharia A, Victor DW, Nguyen DT, Graviss EA, Kaseb AO, McFadden RS, Aloia TA, Conrad C, Li XC, Monsour HP, Gaber AO, Vauthey JN, Ghobrial RM; Methodist-MD Anderson Joint Cholangiocarcinoma Collaborative Committee (MMAJCCC). Liver transplantation for locally advanced intrahepatic cholangiocarcinoma treated with neoadjuvant therapy: a prospective case-series. Lancet Gastroenterol Hepatol. 2018 May;3(5):337-348. doi: 10.1016/S2468-1253(18)30045-1. Epub 2018 Mar 13. PMID 29548617
- BACKGROUNDMcMillan RR, Javle M, Kodali S, Saharia A, Mobley C, Heyne K, Hobeika MJ, Lunsford KE, Victor DW 3rd, Shetty A, McFadden RS, Abdelrahim M, Kaseb A, Divatia M, Yu N, Nolte Fong J, Moore LW, Nguyen DT, Graviss EA, Gaber AO, Vauthey JN, Ghobrial RM. Survival following liver transplantation for locally advanced, unresectable intrahepatic cholangiocarcinoma. Am J Transplant. 2022 Mar;22(3):823-832. doi: 10.1111/ajt.16906. Epub 2021 Dec 27. PMID 34856069