NCT05185245Recruiting
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
Source: ClinicalTrials.gov · Last updated 11 Jan 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study aims to evaluate the efficacy of liver transplantation in the context of non-resectable colorectal liver metastasis. The primary endpoint is the overall survival in this group of patients while the secondary endpoint is the disease-free survival. Patients included in this protocol will be evaluated either for whole or partial liver transplantation from deceased or living donors. Type of different transplantations proposed are as follows: 1. Whole liver graft or partial liver (split) from a deceased donor 2. Partial liver graft retrieved from a deceased donor and orthotopically implanted after having performed a left hepatectomy in the recipient. 3. Partial liver graft retrieved from a deceased donor and heterotopically implanted if total hepatectomy can not be performed. 4. Partial liver graft retrieved from a living donor and orthotopically implanted after having performed total hepatectomy. 5. Partial liver graft retrieved from a living donor and orthotopically implanted after having after having performed a left hepatectomy in the recipient. 6. Partial liver graft retrieved from a living donor and heterotopically implanted if total hepatectomy can not be performed. In cases 2-3-5-6 total hepatectomy of native liver can be secondarily performed after having achieved a proper graft hypertrophy in order to avoid a small for size syndrome
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 10 Dec 2021
- Start date
- 1 Apr 2021
- Primary completion date
- 30 Mar 2025
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Diseases
- Colorectal cancer
- NCT number
- NCT05185245
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Apr 2021 to the primary completion date, 30 Mar 2025
- 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
- Patients who did not receive any neoadjuvant or adjuvant therapy
- Palliative resection of primary tumor
Other illness
- Presence of other malignancies
- Extra-hepatic metastatic disease
Other
- Local recurrence of primary tumor
- Any other reason, according to the investigators, that could be a contraindication to protocol enrollment
Who the study is looking for
- Primary tumor resected according to standard oncological practice, p≤T4a, R0 resection
- Colorectal liver metastasis considered as non-resectable either up-front or after previous hepatic resections
- No local recurrence of primary colon cancer confirmed by Positron Emission Tomography, Computed Tomography and colonoscopy
- No extra-hepatic metastatic disease confirmed by Positron Emission Tomography and Computed Tomography
- Good performance status Eastern Cooperative Oncology Group 0 or 1
- Neutrophils \> 1.000
- Patients who received at least one line of chemotherapy for at least 3 months with partial response or stable disease according to modified Response Evaluation Criteria in Solid Tumours
- Carcino-Embryonic Antigen \< 80 µg/L or reduction of ≥ 50% of highest Carcino-Embryonic Antigen level observed
- Written informed consent
- No other contraindications to liver transplantation
Age in the registry: 18 years to 73 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.