LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis

Launched by AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA · Jan 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of living donor liver transplants (LDLT) for patients with advanced colorectal cancer that has spread to the liver, making it difficult to treat with surgery. The goal is to see how well this treatment works in helping patients live longer and to check their health after the transplant. The study is looking for participants aged 18 and older who have been diagnosed with specific types of colon or rectal cancer, have liver metastases that cannot be removed by surgery, and show a positive response to previous treatments.

If you join the trial, you will receive a liver transplant from a living donor, and researchers will monitor your health closely to see how well the treatment works and how safe it is. They will also look at the health of the donors and their quality of life after the procedure. It’s important to know that this study has specific criteria for who can participate, so not everyone will qualify. If you or a loved one is interested, please discuss it with your healthcare provider to see if this trial might be an option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18.
• • Histologically confirmed colon and rectum (intraperitoneal) adenocarcinoma.
• • Pathological classification of primary tumor as pT1-3, pN0 or pN1 (metastases in \< 4 regional lymph nodes), without peritoneal tumor deposits, absence of mucinous component \>50%, confirmed R0 resection, no limitations for RAS mutations, B-RAF wild type.
• • No signs of extra hepatic metastatic disease or local recurrence according to CT scan+MRI+PET/CT scans.
• • Liver metastases not eligible for curative liver resection
• • Objective response according to RECIST 1.1 to first-line treatment, with sustained response for at least 4 months, OR disease control (complete \[CR\] or partial response \[PR\] or standard disease \[SD\]) during second- line treatment for at least 4 months.
• • Carcinoembryonic Antigen (CEA) values stable or decreasing during the enrollment prior to liver transplant.
• • Performance status, ECOG (Eastern Cooperative Oncology Group) 0-2.
• • Signed informed consent and expected cooperation of the patients for the treatment and follow-up, and national/local regulations.
• Exclusion Criteria:
• • Hereditary CRC syndromes including FAP (Familial adenomatous polyposis) and Lynch syndrome.
• • Prior extra hepatic metastatic disease or primary tumor local relapse.
• • Palliative resection of primary CRC tumor.
• • Disease progression
• • Other malignancies in the previous 5 years (with exception of in situ cervical carcinoma and basal cell carcinoma; superficial bladder tumors are allowed if curatively treated).
• • Active intra-venous or alcohol abusers (patients may be eligible if abstention \> 6 months is demonstrated)
• • Active HIV infection
• • Psychiatric disorders and patient low compliance
• • Any reason why, in the judgment of the investigators, the patient should not participate (to be formally declared)