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Trial design and end points in hepatocellular carcinoma: an EASL-AASLD-ILCA consensus statement
Josep M Llovet1,2,3, Ezequiel Mauro4, Lorenza Rimassa5,6
1Liver Cancer Translational Research Group - Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Liver Unit-Hospital Clínic, Universitat de Barcelona, Barcelona, Spain. jmllovet@clinic.cat.
Nature Reviews. Clinical Oncology
|June 10, 2026
Summary
Hepatocellular carcinoma (HCC) treatment has evolved, but trial designs need updates. Four societies created consensus recommendations to optimize HCC clinical trials and improve patient outcomes.
Area of Science:
- Hepatology and Oncology
- Clinical Trial Design
- Translational Medicine
Background:
- Hepatocellular carcinoma (HCC) management has rapidly evolved, with immunotherapies now central to advanced-stage treatment.
- Discrepancies exist between positive clinical trial results and guideline/regulatory adoption, necessitating updated trial design standards.
Purpose of the Study:
- To address unmet needs and future challenges in HCC clinical trial design and endpoints.
- To harmonize and update current standards for HCC clinical trials through a consensus process.
Main Methods:
- A modified Delphi process was employed by representatives from four major scientific societies (EASL, AASLD, ILCA, ASCO).
- Development of 102 consensus statements across key domains including surveillance, disease stages, transplant contexts, and regulatory considerations.
Main Results:
- The consensus document provides rigorous definitions for target populations, stratification factors, control arms, and clinical benefit benchmarks.
- Recommendations cover surveillance, early, intermediate, and advanced-stage HCC, transplant settings, regulatory aspects, and emerging topics.
Conclusions:
- This multisociety roadmap aims to optimize HCC trial design and accelerate therapeutic development.
- The consensus provides an evidence-based framework to improve clinically meaningful outcomes for patients with hepatocellular carcinoma.
