Clinical trial NCT05185245: Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
Official title: Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Metastasis Colon Cancer
Colorectal Cancer
Keywords: liver transplantation
non-resectable colorectal liver metastasis
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Presence of other malignancies
* Local recurrence of primary tumor
* Extra-hepatic metastatic disease
* Patients who did not receive any neoadjuvant or adjuvant therapy
* Palliative resection of primary tumor
* Any other reason, according to the investigators, that could be a contraindication to protocol enrollment

Primary outcomes:
measure: Overall Survival
timeFrame: 5 years
Secondary outcomes:
measure: Disease-Free Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero - Universitaria di Bologna
Study officials:
References: