Robin Kate Kelley

Abstract The management of hepatocellular carcinoma (HCC) has undergone radical change over the past decade. Immunotherapies now dominate the treatment of advanced-stage disease and are increasingly being evaluated in perioperative and intermediate-stage settings. However, in some instances, positive phase III trials have not translated into adoption by guidelines or regulatory agencies, highlighting the need to harmonize and update the current standards for trial design and end points.

INTRODUCTION Clinical trials are the cornerstone of cancer therapy development, with their success hinging on carefully designed eligibility criteria that define the study population.1, 2 Although these criteria aim to identify patients most likely to benefit from experimental treatments and minimize safety risks, an emerging challenge has become apparent: overly restrictive requirements may exclude a significant proportion of real-world patients who could potentially benefit from trial...

WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? A single-dose regimen of tremelimumab 300 mg in combination with durvalumab (STRIDE) significantly improved overall survival and had a favorable benefit–risk profile in patients with unresectable hepatocellular carcinoma (uHCC) in the phase I/II Study 22, confirmed by the results of the phase III HIMALAYA study. WHAT QUESTION DID THIS STUDY ADDRESS?