EASL Pre-Congress event:
Consensus Conference: Trial design and end-points in HCC
This one-day consensus conference is taking place the day before EASL Congress 2025 in Amsterdam.
The event is aimed to integrate the current knowledge in trial design and endpoints in HCC and provide a new frame for ongoing and future trial in the field of HCC. A review of the current management and novel therapeutical approaches will be provided.
Date and time: 6 May 2025, 9:00-17:30 CEST
Josep M. Llovet
Chair
Richard Finn
Co-chair
Tim Meyer
Co-chair
Arndt Vogel
Co-chair
Amit Singal
Co-chair
Review the current trial design and end points in early, intermediate and advanced HCC, and the need for a new agreement considering the outcomes of recent RCT.
Recommendations will be focused on phase II and III trials.
Review how biomarkers can be integrated in the management of HCC along with tumor biopsies and circulating ct DNA assays in guiding therapeutic decision-making.
Review the armamentarium of therapies available and anticipate the potential role of triplet regimens, cell therapies, vaccines and other novel approaches.
Understand the views of academia, regulatory agencies and patients about criteria for defining clinical benefit and potential regulatory approval.
Programme
The meeting will convoke experts in hepatocellular carcinoma and trial design from EASL, AASLD, ASCO and ILCA alongside government regulatory representatives and patient advocates, to review and update clinical trial endpoints and designs for hepatocellular carcinoma (HCC) across all stages. Building on recent trials, discussions will focus on defining clinical benefit, establishing standards for upcoming trials, and examining regulatory strategies for Phase III trials, with emphasis on key end-points. This forum welcomes hepatologists, oncologists, surgeons, radiologists, interventional oncologists and health care professionals involved in the management of liver cancer along with industry partners to shape future directives and foster innovation in HCC management. As a result of this single topic conference a consensus manuscript will be reported.
This session will provide a comprehensive review of oncology end-points used for regulatory approval. Experts will discuss the implications of EASL, AASLD, and ASCO guidelines on trial design. The session will cover the clinical validity of key end-points, including Overall Survival (OS), Progression-Free Survival (PFS), Time to Progression (TTP), Objective Response Rate (ORR), and Patient-Reported Outcomes (PROs). Criteria of surrogacy will be discussed.
This session will focus on the design of neoadjuvant and adjuvant trials in HCC, defining inclusion criteria, stratification factors, and control arms. The discussion will emphasize the selection of appropriate end-points, such as Recurrence-Free Survival (RFS) and pathological response, alongside standard radiological and pathological assessment methods. For intermediate-stage HCC, experts will analyze inclusion criteria, stratification factors, and control arm selection, comparing OS and PFS as primary end-points. Also, whether combination of end-points would be needed for regulatory approval or acceptance in guidelines.
This session will address evidence-based management strategies for advanced HCC, focusing on clinically meaningful survival outcomes (OS , PFS) and stratification factors across HCC stages. It will explore inclusion criteria, stratification factors, and control arm options in this setting. Additionally, standard radiological response assessment methods and key factors for interpreting clinical relevance will be discussed.
This session will explore the role of biomarkers in patient selection and stratification, as well as tools for assessing quality of life and PROs. In addition, emerging topics in trial design will be addressed, the session will also highlight disparities in the trial design and the importance of patient engagement in trial development. The program will conclude with key recommendations and priority areas for future HCC research.
Methodology
First, the panelists will provide a draft document with recommendations prior to the meeting on June 2025.
During the meeting, all recommendations will be analyzed. In principle, the panel would explore achieving a consensus agreement, although in special circumstances a majority decision might prevail. In these cases, a minority report will be included in the document.
Afterwards each co-chair will seek the endorsement of each scientific society according to the internal procedures. A final document capturing potential changes will be prepared for submission to Nature Reviews Clinical Oncology by the end of 2025.
Target audience
Hepatologists
Physician Assistants
Oncologist
Transplant Coordinators
Surgeons
Fellows/Trainees
Radiologist
Government/Regulatory Representatives
Nurses
Pharmacists
Industry
Registration
Registration is required to attend the pre-congress event “Trial design and end-points in HCC”. Registered delegates will also receive live-stream and on demand access to the pre-congress event.
Registration fee:
EUR 102.85 (EUR 85 plus 21% Dutch VAT)
Registration process:
- Go to the EASL Congress 2025 registration platform.
- Login with your account or create a new account.
- Select “Individual Registration”
- Click “Next” to accept the Terms & Conditions.
- Select “Register or book tickets for yourself” or “Register or book ticket for someone else” to proceed.
- Select “Participant type”. Add your EASL Membership number if appropriate, and click “Choose tickets” to proceed.
- Add “discount code” if applicable, and click “Next” to proceed.
- Select tickets:
- If you wish to register for both EASL Congress 2025 and the pre-congress event “Trial design and end-points in HCC” please select both tickets.
- If you have already register for EASL Congress 2025 or wish to only register for the pre-congress event “Trial design and end-points in HCC” please only select the applicable ticket.
- Complete all other required fields and proceed to payment to confirm your registration.
Questions:
For registration queries, please contact: EASLcongress.registration@easloffice.eu
