NCT04742621 Liver Transplantation for Unresectable Liver Limited Colorectal Metastases
| NCT ID | NCT04742621 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Unresectable Liver-limited Colorectal Metastases |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2020-09-30 |
| Primary Completion | 2034-07-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2020-09-30 with a primary completion date of 2034-07-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a single-arm, single institution pilot registry of liver transplantation in patients with unresectable colorectal liver-only metastases at Weill Cornell Medical College. Patients with liver predominant colorectal liver metastases will be screened based on eligibility criteria in a specified clinical hepatobiliary and colorectal liver metastasis tumor board consisting of the principal and co-investigators, representing medical oncology, transplant surgery, radiology, and pathology. The registry aims to track basic demographic data as well as referral patterns, in addition to specific oncologic data such as tumor burden, extent of disease, extent of disease on explant, recurrence rates, patterns of recurrence and survival rates.
Eligibility 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
Contact & Investigator
Benjamin Samstein, MD
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT04742621 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Unresectable Liver-limited Colorectal Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04742621 currently recruiting?
Yes, NCT04742621 is actively recruiting participants. Contact the research team at samstei@med.cornell.edu for enrollment information.
Where is the NCT04742621 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT04742621 clinical trial?
NCT04742621 is sponsored by Weill Medical College of Cornell University. The principal investigator is Benjamin Samstein, MD at Weill Medical College of Cornell University. The trial plans to enroll 20 participants.