Clinical trial NCT04742621: Liver Transplantation for Unresectable Liver Limited Colorectal Metastases
Official title: Liver Transplantation for Unresectable Liver Limited Colorectal Metastases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Unresectable Liver-limited Colorectal Metastases
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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. If deemed acceptable candidates for liver transplantation, they will then undergo transplant evaluation as per Weill Cornell Medical College Liver Transplant clinical protocols.

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

Primary outcomes:
measure: To develop a registry of liver transplantation in patients with liver limited metastatic colorectal cancer at Weill Cornell Medical College / New York-Presbyterian Hospital (WCMC / NYPH)
timeFrame: 25 years
Secondary outcomes:
measure: To determine disease-free survival (DFS) in patients that receive a liver transplant for metastatic colorectal cancer at Weill Cornell Medical College / New York-Presbyterian Hospital
timeFrame: 25 years
measure: To determine overall survival (OS) in patients that receive a liver transplant for metastatic colorectal cancer at Weill Cornell Medical College / New York-Presbyterian Hospital
timeFrame: 25 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Benjamin Samstein, MD
role: PRINCIPAL_INVESTIGATOR
References: