Condition: Hepatocellular Carcinoma · Sponsor: UNICANCER
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.
This description comes directly from the study's public registry record.
Veronica PEZZELLA · +33 6 28 69 53 14 · v-pezzella@unicancer.fr
Guillaume BRARD · g-brard@unicancer.fr
Always discuss trial participation with your own doctor first.
| CHU de Bordeaux | Bordeaux, France | Not Yet Recruiting |
| AP-HP Hôpital Beaujon | Clichy, France | Recruiting |
| Centre Georges Francois Leclerc | Dijon, France | Not Yet Recruiting |
| Hôpital Saint Joseph | Marseille, France | Recruiting |
| CHU de Montpellier | Montpellier, France | Not Yet Recruiting |
| CHU Hôtel-Dieu | Nantes, France | Not Yet Recruiting |
| AP-HP Hôpital Cochin | Paris, France | Recruiting |
| CHU de Poitiers | Poitiers, France | Not Yet Recruiting |
| Centre Eugene Marquis | Rennes, France | Recruiting |
| CHRU de Strasbourg | Strasbourg, France | Not Yet Recruiting |
| CHU de Rangueil | Toulouse, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06904170