Liver Transplantation for Unresectable Liver Limited Colorectal Metastases

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Histologically confirmed adenocarcinoma of the colon or rectum

• No evidence of extrahepatic metastases or local recurrence based on PET/CT and colonoscopy

• No signs of extrahepatic metastases or local recurrence according to PET/CT 4 weeks prior to consideration of transplant

• Age 18-65 years old

• Good performance status with ECOG 0-1

• Stability or regression of liver metastasis for at least 6 months

• Minimum of 1 year between diagnosis of colon cancer and liver transplant and 6 months from primary tumor resection and liver transplant

• Minimum of 6 months chemotherapy

• CEA \< 200 ug/L 3 months prior to transplant

⁃ 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

Locations
United States
New York
Weill Cornell Medicine
RECRUITING
New York
Contact Information
Primary
Benjamin M Samstein, MD
samstei@med.cornell.edu
212-746-2127
Time Frame
Start Date: 2020-09-30
Estimated Completion Date: 2035-07-27
Participants
Target number of participants: 20
Related Therapeutic Areas
Sponsors
Leads: Weill Medical College of Cornell University

This content was sourced from clinicaltrials.gov