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

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 - TOM

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00014582

Enrollment

630

Registered

2020-02-12

Start date

2020-06-15

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C22.0

Interventions

Group 1: Patients with cirrhosis and HCC (hepatocellular carcinoma) within UNOS T2. These patients receive a waiting list bonus from listing by Eurotransplant. The patient treatment and aftercare afte

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Recurrence-free patient survival 2 years after liver transplantation is compared in both study arms.	—

Secondary

Measure	Time frame
1) Patient survival 2 years after liver transplantation will be compared between both study arms. 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. 3) Tumor-specific drop-out rate (TSDOR) will be compared between both study arms. 4) Response to bridging therapy will be compared between both study arms. 5) Patient survival and tumor-free patient survival after 2 years after liver transplantation will be analyzed and compared in consideration of (a) histopathological grading, (b) microvascular (as well as macrovascular) invasion and (c) the tumor marker AFP between both study arms.	—

Measure

Time frame

1) Patient survival 2 years after liver transplantation will be compared between both study arms. 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. 3) Tumor-specific drop-out rate (TSDOR) will be compared between both study arms. 4) Response to bridging therapy will be compared between both study arms. 5) Patient survival and tumor-free patient survival after 2 years after liver transplantation will be analyzed and compared in consideration of (a) histopathological grading, (b) microvascular (as well as macrovascular) invasion and (c) the tumor marker AFP between both study arms.

—

Countries

Germany

Contacts

Public ContactFelix Braun

Universitätsklinikum Schleswig Holstein, Klinik für Allgemeine, Viszeral- Thorax-, Transplantations- und Kinderchirurgie

felix.braun@uksh.de+49(0)431/500-33421

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026