An integrated Phase II/III randomized study comparing durvalumab and tremelimumab ± Hepatic ArteriaL infusion chemotherapy with GEMOX in hepatocellular Carcinoma with high tumor burdEn – ALICE (PRODIGE89 – UCGI44 – ALICE)
Year: 2026
Type: article
Study design: Study Protocol
Abstract: Patients with advanced hepatocellular carcinoma and high tumour burden (Vp4 PVTT, Vp3 PVTT with bilateral involvement, >50% liver involvement) have poor outcomes and are under-represented in major hepatocellular carcinoma trials (1,2). HAIC has been widely studied in Asian population, with positive results especially in patients with high tumour burden but is not validated in Western population. The ALICE study is a multicentre, French, open-label, randomised integrated phase II/III trial designed to evaluate the safety and efficacy of GEMOX (gemcitabine and oxaliplatin)-based HAIC in combination with durvalumab and tremelimumab, versus durvalumab and tremelimumab alone in this population. A total of 90 and 196 patients will be enrolled in the phase II and phase III components, respectively, and randomised 1:1 between the two treatment arms. Primary endpoints are objective response rate (RECIST 1.1) for phase II and overall survival for phase III. A safety run-in with independent Data and Safety Monitoring Board review is planned during phase II to assess tolerance of the combination. Progression to phase III will depend on a predefined futility rule based on the ORR observed in the experimental arm.
Source: Digestive and Liver Disease
Authors: Octave Letissier, Xavier Adhoute, Boris Campillo-Gimenez, Mohamed Bouattour, Jean-Marie Peron, Amina Larbi, François Ghiringhelli, Yann Touchefeu, Anaïs Vallet-pichard, Laurent Mineur, Valérie Boige, Antonio Saviano, Jean-Frédéric Blanc, Giuliana Amaddeo, Olivier Rosmorduc, Manon Allaire, Thomas Decaens, Frédéric Di Fiore, Eric Nguyen Khac, Laure Monard, Veronica Pezzella, Aïcha Ben Hariz, Boris Guiu, Julien Edeline
Institutions: Centre Eugène Marquis, Hôpital Saint Joseph, Hôpital Beaujon, Hôpital Rangueil, Centre Hospitalier Universitaire de Poitiers, Centre Georges François Leclerc, Centre Hospitalier Universitaire de Nantes, Hôpital Cochin, Assistance Publique – Hôpitaux de Paris, Institut Gustave Roussy, Fondation Gustave Roussy, Hôpitaux Universitaires de Strasbourg, Centre Hospitalier Universitaire Henri-Mondor, Hôpitaux Universitaires Henri-Mondor, Hôpital Paul-Brousse, Pitié-Salpêtrière Hospital, Centre Hospitalier Universitaire de Grenoble, Centre Hospitalier Universitaire de Rouen, Centre Hospitalier Universitaire Amiens-Picardie, UniCancer Group, Centre Hospitalier Universitaire de Montpellier
Language: English
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,300
OpenAlex ID: W7213082406