NCT04616495 Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
| NCT ID | NCT04616495 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitario La Fe |
| Condition | Colorectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2021-09-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Multicentric prospective and observational study to assess the 5-year overall survival in a cohort of patients with unresectable liver-only colorectal metastases, well controlled by chemotherapy prior to liver transplantation.
Eligibility Criteria
Inclusion Criteria: * ≥ 18 and ≤ years * Good performance status, ECOG 0 or 1 * Resected adenocarcinoma in colon or rectum (R0 resection) * Unresectable liver metastases * No extrahepatic disease * Normal blood tests * Response to ≤ 2 lines of chemotherapy (RECIST criteria) * ≥ 1 year period since diagnosis of colorectal cancer to enrolment in liver transplant waiting list * Signed informed consent Exclusion Criteria: * Body mass index ≥ 30 * Positive HIV or HCV * Pregnancy at the time of inclusion * BRAF mutated status * Deterioration of general condition (10% weight loss in the prior 6 months) * Other malignancy with disease free survival \< 5 years * Concomitant or prior extrahepatic metastases (histologically or radiologically proved), even if surgically resected. * Palliative resection of primary colorectal adenocarcinoma * Liver metastases size \> 5 cm (in the last imaging technique) * CEA \> 80 ng/ml (at time of enrolment in waiting list) * No neoadjuvant chemotherapy treatment * General contraindication to liver transplantation
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04616495 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04616495 currently recruiting?
Yes, NCT04616495 is actively recruiting participants. Contact the research team at montalva.oron@gmail.com for enrollment information.
Where is the NCT04616495 trial being conducted?
This trial is being conducted at Valencia, Spain.
Who is sponsoring the NCT04616495 clinical trial?
NCT04616495 is sponsored by Hospital Universitario La Fe. The trial plans to enroll 30 participants.
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