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
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable colorectal-cancer
Started Aug 2016
Longer than P75 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 3, 2016
CompletedFirst Submitted
Initial submission to the registry
August 4, 2016
CompletedFirst Posted
Study publicly available on registry
August 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
ExpectedJune 18, 2024
June 1, 2024
9.3 years
August 4, 2016
June 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
patient survival
5 years
disease-free survival
5 years
Secondary Outcomes (9)
patterns of cancer recurrence after liver transplantation
5 years
types of cancer recurrence treatments
5 years
Number of participants that drop out of study prior to receiving intervention (transplantation surgery) due to chemotherapy-related adverse events, as assessed by CTCAE v4.0
prior to liver transplantation
self-reported quality of life as assessed by EORTC QLQ-C30 questionnaire
6 month intervals for 5 years
survival of intervention vs standard treatment
1-, 3- and 5 years
- +4 more secondary outcomes
Study Arms (1)
transplantation
EXPERIMENTALLive donor liver transplantation for the treatment of unresectable colorectal cancer liver metastases
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
Related Publications (1)
Rajendran 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: 37130158DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gonzalo Sapisochin, MD
University Health Network, Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2016
First Posted
August 12, 2016
Study Start
August 3, 2016
Primary Completion
December 1, 2025
Study Completion (Estimated)
December 1, 2030
Last Updated
June 18, 2024
Record last verified: 2024-06