Liver transplantation for patients with liver-limited colorectal cancer
Official title: Liver Transplantation for Unresectable Liver Limited Colorectal Metastases
Run by Weill Medical College of Cornell University · NCT04742621 · Data updated 2026-11-12
This study is trying to see if liver transplants can help patients with colorectal cancer that has spread only to the liver and can't be removed by surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | September 30, 2020 |
| Main results expected | July 27, 2034 |
| Study ends | July 27, 2035 |
| Registry record updated | December 11, 2025 |
| Trial ID | NCT04742621 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-65 with histologically confirmed adenocarcinoma of the colon or rectum and no evidence of extrahepatic disease.
✕Probably not a fit
Patients with evidence of extrahepatic disease or local recurrence will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational pilot registry focuses on liver transplantation in patients with unresectable colorectal liver-only metastases at Weill Cornell Medical College. Eligible patients will be screened by a multidisciplinary tumor board, which includes experts in medical oncology, transplant surgery, radiology, and pathology. The registry aims to collect demographic and oncologic data, including tumor burden, recurrence rates, and survival outcomes, to better understand the potential role of liver transplantation in this patient population.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with unresectable liver-limited colorectal metastases.
How similar studies have gone: While liver transplantation for colorectal metastases is a novel approach, similar studies have shown promising results in select patient populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the colon or rectum 2. No evidence of extrahepatic metastases or local recurrence based on PET/CT and colonoscopy 3. No signs of extrahepatic metastases or local recurrence according to PET/CT 4 weeks prior to consideration of transplant 4. Age 18-65 years old 5. Good performance status with ECOG 0-1 6. Stability or regression of liver metastasis for at least 6 months 7. Minimum of 1 year between diagnosis of colon cancer and liver transplant and 6 months from primary tumor resection and liver transplant 8. Minimum of 6 months chemotherapy 9. CEA \< 200 ug/L 3 months prior to transplant 10. Adequate organ and marrow function with Hb \> 10 g/dL, ANC \> 1000/uL, platelets \> 100,000/uL, bilirubin \< 2x ULN, AST/ALT \< 5x ULN, Creatinine \< 1.25 x ULN, Albumin above LLN Exclusion Criteria: 1. Evidence of extrahepatic disease or local recurrence 2. Previous resection of lung metastases 3. MSI-H/dMMR or BRAF mutation 4. Any other medical or co-morbid condition that would preclude liver transplantation, as determined by the transplant team
Where it's running
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Weill Cornell Medicine
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Benjamin Samstein, MD — Weill Medical College of Cornell University
- Study coordinator: Benjamin M Samstein, MD
- Email: samstei@med.cornell.edu
- Phone: 212-746-2127
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.