Clinical trial · Interventional
Living Donor Liver Transplantation for Unresectable Colorectal Cancer Liver Metastases
Assessment of a Protocol Using a Combination of Neo-adjuvant Chemotherapy Plus Living Donor Liver Transplantation for Non-Resectable Liver Metastases From Colorectal Cancer
- 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)
Patients with unresectable liver metastases (LM) from colorectal cancer (CRC)have a poor prognosis. In patients with resectable disease, surgery offers a distinct survival benefit. This study will offer live donor liver transplantation (LDLT) to select patients with unresectable metastases that are 1) limited to the liver and 2) stable (non-progressing) on standard chemotherapy. Potential participants will be evaluated for liver transplant suitability and must also have a willing, healthy living donor come forward for evaluation. Those participants who undergo LDLT will be followed for survival, disease-free survival and quality of life for 5 years and compared to a "control group" of participants who drop out of study prior to transplantation due to reasons other than cancer progression.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Liver Metastases | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| live donor liver transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- transplantation
- description
- Live donor liver transplantation for the treatment of unresectable colorectal cancer liver metastases
- interventionNames
- Procedure: live donor liver transplantation
Primary outcomes (2)
- measure
- patient survival
- timeFrame
- 5 years
- measure
- disease-free survival
- timeFrame
- 5 years
Secondary outcomes (9)
- measure
- patterns of cancer recurrence after liver transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 68 Years
Show eligibility criteria text
Inclusion Criteria: * Must reside in Canada * ECOG ( Eastern Cooperative Oncology Group) score : 0-1 at all times prior to LDLT (excursions to ECOG 2 allowed at investigator's discretion) * Proven colorectal Liver Metastases (LM). * Willing and able to provide written informed consent. * Negative serum pregnancy test for women of childbearing potential * Both men and women must agree to use adequate barrier birth control measures during the course of the trial. * At least 1 "acceptable", ABO-compatible living donor has stepped forward * Primary Colorectal cancer tumor stage is ≤T4a * Time from primary CRC resection to transplant is ≥6 months * Bilateral and non-resectable LM * No major vascular invasion by LM; metastases isolated to liver * The patient has undergone systemic chemotherapy (eg. FOLFOX +/- bevacizumab or FOLFIRI +/- bevacizumab) for ≥3 months * demonstrated stability or regression of LM over at minimum the 3 months preceding screening * Carcinoembryonic Antigen (CEA) values are stable or decreasing at all timepoints prior to the transplant surgery. Exclusion Criteria: * Previous or concurrent cancer (with some exceptions) * prior lung resection * Progression of LM at any timepoint prior to transplant surgery * Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min * Pulmonary insufficiency * History of cardiac disease * Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B and/or C infection. * Patients with debilitating neuropathy. (CTCAE \> grade 2) * BRAF + tumors * Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
References
Publications (1)
- DERIVEDRajendran L, Claasen MP, McGilvray ID, Cattral MS, Ghanekar A, Selzner N, Burkes R, Winter E, Gallinger S, Sapisochin G. Toronto Management of Initially Unresectable Liver Metastasis from Colorectal Cancer in a Living Donor Liver Transplant Program. J Am Coll Surg. 2023 Aug 1;237(2):231-242. doi: 10.1097/XCS.0000000000000734. Epub 2023 May 3. PMID 37130158