Prospective, multicenter, comparative study of recurrence-free survival after liver transplantation in two tumor stage-defined groups (UNOS T2 versus Milan-out / UCSF-in) of patients with hepatocellular carcinoma (HCC) in cirrhosis and locoregional therapy for bridging the waiting period

Not Applicable

• Conditions: C22.0; Liver cell carcinoma

• Registration Number: DRKS00014582
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-12
• Study Completion: 2021-03-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Patients with HCC in cirrhosis according to current guidelines
- Patients with HCC in cirrhosis in the tumor stage UNOS T2 or patients with HCC in cirrhosis outside Milan and within the UCSF criteria
- Age from 18 years
- Decision of the transplant conference with approval for liver transplantation
- Decision of the tumor conference with diagnosis and tumor stage
- Listing at Eurotransplant

Exclusion Criteria

- Patients with extrahepatic HCC manifestation (N + M +)
- patients with macrovascular invasion of HCC (V2)
- Existing pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence-free patient survival 2 years after liver transplantation is compared in both study arms.

Secondary Outcome Measures

Name	Time	Method
1) Patient survival 2 years after liver transplantation will be compared between both study arms.<br>2) Patient survival and tumor-free patient survival after initial diagnosis of HCC will be compared in an intention-to-treat (ITT) analysis within the 2-year follow-up period after liver transplantation between both arms.<br>3) Tumor-specific drop-out rate (TSDOR) will be compared between both study arms.<br>4) Response to bridging therapy will be compared between both study arms.<br>5) Patient survival and tumor-free patient survival after 2 years after liver transplantation will be analyzed and compared in consideration of<br>(a) histopathological grading,<br>(b) microvascular (as well as macrovascular) invasion and<br>(c) the tumor marker AFP <br>between both study arms.