Liver transplantation for colorectal cancer patients with liver metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial involves a two-stage surgical procedure for patients with colorectal cancer and liver metastases that cannot be surgically removed. Initially, liver segments 2 and 3 are removed from the patient and replaced with donor segments. After the donor segments have grown, the remaining liver segments of the patient are removed, leaving only the donor liver tissue. This innovative approach aims to improve outcomes for patients with advanced liver disease due to cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically verified adenocarcinoma in colon/rectum.
* Liver metastases, not amenable to liver resection
* No signs of extra hepatic metastatic disease or local recurrence according to PET/CT scan within 4 weeks prior to the faculty meeting at the transplant unit, except patients may have 1-3 resectable lung lesions all\<15mm.
* No signs of extra hepatic metastatic disease on CT thorax/abdomen/pelvis within 4 weeks prior to the faculty meeting at the transplant unit, except patients may have 1-3 resectable lung lesions all\<15mm.
* No local recurrence according to MR-pelvis scan in patients with rectal cancer within 4 weeks prior to the faculty meeting at the transplant unit
* No signs of local recurrence judged by colonoscopy / CT colography within 12 months prior to the faculty meeting at the transplant unit
* Good performance status, ECOG 0 or 1.
* Satisfactory blood tests: Hb \>10g/dl, neutrophiles \>1.0 (after any G-CSF), TRC \>75, Bilirubin\<2 x upper normal level, ASAT,ALAT\<5 x upper normal level, Creatinine \<1.25 x upper normal level. Albumin above lower normal level.
* Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to GCP, and national/local regulations.
* All patients should have received at least 8 weeks of chemotherapy.

Exclusion Criteria:

* Weight loss \>10% the last 6 months
* Patient BMI \> 30
* Previous diagnosed bone or CNS metastatic disease.
* Previous diagnosed cancer mammae or malignant melanoma.
* Palliative resection of primary CRC tumor.

Where it's running

• Oslo University Hospital
  Oslo, Norway Recruiting

Study contacts

• Study coordinator: Magnus Smedman, MD
• Email: torha@ous-hf.no
• Phone: 23026600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.