NCT04616495Recruiting
Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
Source: ClinicalTrials.gov · Last updated 22 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 25 Sept 2020
- Start date
- 1 Sept 2021
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Hospital Universitario La Fe
- NCT number
- NCT04616495
What you commit to
- Study type: Observational
- Planned participants: 30
- From 1 Sept 2021 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Deterioration of general condition (10% weight loss in the prior 6 months)
- Concomitant or prior extrahepatic metastases (histologically or radiologically proved), even if surgically resected.
- Palliative resection of primary colorectal adenocarcinoma
- No neoadjuvant chemotherapy treatment
- General contraindication to liver transplantation
Other illness
- Positive HIV or HCV
Age
- Other malignancy with disease free survival \< 5 years
Other
- Body mass index ≥ 30
- Pregnancy at the time of inclusion
- BRAF mutated status
- Liver metastases size \> 5 cm (in the last imaging technique)
- CEA \> 80 ng/ml (at time of enrolment in waiting list)
Who the study is looking for
- ≥ 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
Age in the registry: 18 years to 65 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eva M Montalvá Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.