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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)
Liver cancer is a highly lethal malignancy and has become increasingly important in western countries. The management of liver cancer is complex. In advanced disease, two combinations of immunotherapies are recommanded as first line (atezolizumab-bevacizumab or durvalumab-tremelimumab). Results in patients with high tumor burden (Portal vein thrombosis Vp3 or Vp4, or tumoral liver involvement \>50%) are less impressive. Innovative combinations are necessary to improve the outcome of patients. Recently, control trials conducted in Asia highlighted the benefit of hepatic arterial infusion chemotherapy, especially in patients with high tumor burden. Studies including a limited number of patients shown that the combination seems feasible. ALICE is a randomized multicentric Phase II/Phase III trial conducted in French medical centers, evaluating the efficacy and safety of durvalumab+tremelimumab with or without Hepatic Arterial Infusion Chemotherapy of the GEMOX regimen (gemcitabine + oxaliplatin), in patients with high tumor burden. Oxaliplatin induce immunogenic cell death, and gemcitabin deplete regulatory immune cells. The GEMOX regimen thus has the potential for a synergic effect with immunotherapy in HCC. The trial will provide an innovative treatment to patients with no alternative for locoregional treatment, and with limited results with actual systemic treatments. It will also be the first trial of Hepatic Arterial infusion for such patients in the western population.
Details
| Lead sponsor | UNICANCER |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | RECRUITING |
| Enrolment | 196 |
| Start date | 2025-11-14 |
| Completion | 2030-09 |
Conditions
- Hepatocellular Carcinoma
Interventions
- Durvalumab Plus Tremelimumab
- HAIC (GEMOX)
Primary outcomes
- Phase II : Objective Response Rate according to RECIST 1.1 — From date of randomization until the date of first documented progression, and up to 6 months after the inclusion of the last patient
The proportion of patients with Complete Response or Partial Response according to RECIST 1.1 - Phase III : Overall Survival — From date of randomization to the date of death, up to 18 months after the randomization of the last patient
The time between Randomisation and death from any cause
Countries
France