Living donor liver transplantation for non-resectable colorectal liver metastases

JRCT ID: jRCT1050230053

Registered date:25/06/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: non-resectable colorectal liver metastases
• Date of first enrollment: 25/06/2023
• Target sample size: 23
• Study type: Interventional
• Intervention(s): Living donor liver transplantation

Outcome(s)

• Primary Outcome: 3 year overall survival
• Secondary Outcome: short result of liver transplantation, etc.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 70age old
• Gender: Both

Include criteria

1. histological evidence of colorectal adenocarcinoma
2. Genetic testing for cancer (RAS, BRAFV600E, MSI, mismatch repair genes, etc.) must have been performed.
3. The primary colorectal cancer has been curatively resected.
4. the metastatic disease must be considered as surgically unresectable. Liver metastases are not limited to first occurrence, but include those after hepatectomy.
5. The metastases must be located in liver only by imaging diagnosis.
6. No history of distant metastasis other than liver metastasis. Exceptions: Patients with no more than 3 lung metastases and no recurrence for more than 6 months after treatment of lung metastases are eligible.
7.Patients must have received chemotherapy for unresectable liver metastases. The duration of chemotherapy should be at least 3 months, and the regimen should be within the standard of care according to the colorectal cancer guidelines.
8. Patients must be at least 18 years old.

Exclude criteria

1. patients who have undergone chemotherapy and are judged to have progressed (PD).
2. an infectious disease requiring treatment
3. pregnant or possibly pregnant.
4. Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and make it difficult for them to participate in the study.
5. Other cases that are considered not appropriate for usual living donor liver transplantation

Related Information

• Primary Sponsor: Hatano Etsuro
• Secondary ID(s): 000049785