Liver transplantation for patients with liver-limited colorectal cancer
Liver Transplantation for Unresectable Liver Limited Colorectal Metastases
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 |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04742621 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with histologically confirmed adenocarcinoma of the colon or rectum and no evidence of extrahepatic disease.
Not a fit: Patients with evidence of extrahepatic disease or local recurrence will not benefit from this study.
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 performed: While liver transplantation for colorectal metastases is a novel approach, similar studies have shown promising results in select patient populations.
Eligibility criteria
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 this trial is running
New York, New York
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.