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Recruiting
NCT07884110
Liver Transplantation for Colorectal Cancer
Conditions: Colorectal Cancer, Liver Metastasis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 10
Sponsor: Pontificia Universidad Catolica de Chile
Location: Centro del Cáncer UC Santiago Santiago Metropolitan
Summary
This is an observational study that will follow adults with stage IV colorectal cancer whose disease has spread only to the liver (not to other organs) and who are undergoing a liver transplant as part of their cancer treatment. Liver transplantation is being offered as a potentially curative option for patients whose liver metastases cannot be surgically removed. Researchers will review participants' medical records for up to 5 years after transplant to understand how this treatment affects survival, cancer recurrence, and safety. Participants will also be asked to complete a quality-of-life questionnaire (EORTC QLQ-C30). Taking part in this study does not involve any additional tests, visits, or procedures beyond the standard care participants would otherwise receive.
Eligibility Criteria
Inclusion Criteria:
* Adult patients aged 18 years or older at the time of evaluation for liver transplantation.
* Both male and female patients are eligible; there are no restrictions based on sex or gender.
* Patients with colorectal cancer (CRC) for whom liver transplantation has been approved as a potential treatment by the institutional liver transplant committee.
* Histologically confirmed adenocarcinoma of the colon or rectum.
* Patient not eligible for curative liver resection.
* Resection of the primary tumor ≥6 months before the planned date of transplantation.
* Standard surgical procedure with adequate resection margins, including a circumferential resection margin (CRM) of ≥2 mm for patients with rectal cancer.
* No signs of local recurrence on colonoscopy.
* Radiological and biomarker (CEA) response to treatment after at least 6 months of systemic therapy. For some higher-risk patients, the multidisciplinary tumor board may require 12 months of response.
* ECOG performance status 0-1.
* No signs or history of extrahepatic metastases on chest/abdomen/pelvis computed tomography (CAP CT) or magnetic resonance imaging (MRI), and on whole-body positron emission tomography/computed tomography (PET/CT).
* Carcinoembryonic antigen (CEA) level below 80 ng/mL at the time of listing for liver transplantation.
* BRAF wild-type and microsatellite stable (MSS).
* Deemed an appropriate transplant candidate by the liver transplant candidate evaluation committee and in accordance with transplant selection criteria.
* A potential living donor available and eligible under Chilean living-donor transplantation law.
Exclusion Criteria:
* Evidence or history of extrahepatic metastases on CT (chest/abdomen/pelvis), MRI, or whole-body PET/CT
* BRAF-mutated tumor
* Microsatellite instability-high (MSI-H) tumor
Source: ClinicalTrials.gov (NCT07884110). StuddyBuddy aggregates publicly available trial information.