Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

Colorectal Cancer Clinical Trial

Official title:

Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05185245
• Other study ID #: LITORALE2020
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: March 30, 2030

Study information

• Verified date: April 2021
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 30, 2030
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 73 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Liver Metastasis Colon Cancer
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Procedure:
• Liver Transplantation
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis

Locations

Country	Name	City	State
Italy	IRCCS Azienda Ospedaliero - Universitaria di Bologna	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		5 years
Secondary	Disease-Free Survival		5 years