Trial design and end-points in HCC
This one-day Consensus statement 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.
Josep M. Llovet
Chair
Richard Finn
Co-chair
Tim Meyer
Co-chair
Amit Singal
Co-chair
Arndt Vogel
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.
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
