Observational Study of Nivolumab Plus Ipilimumab Treatment for Advanced Unresectable Liver Cancer in Japan

What this Trial Is About

Researchers are evaluating the safety, usage, and effectiveness of a combination of two medicines, nivolumab and ipilimumab, for adults with advanced liver cancer that cannot be removed by surgery. This observational study focuses on patients in Japan who receive this treatment as part of their routine medical care. The purpose is to understand how this therapy performs in standard clinical practice for unresectable hepatocellular carcinoma. Participants receive nivolumab plus ipilimumab combination therapy as first-line systemic treatment. The treatment involves nivolumab 80 mg and ipilimumab 3 mgkg given intravenously every 3 weeks for 4 cycles, followed by nivolumab alone at 240 mg every 2 weeks or 480 mg every 4 weeks. The study observes the treatment as it is prescribed in real-world clinical settings between March 2026 and February 2027. During the study, participants are monitored up to 2 years for immune-related liver injury, treatment response, adverse events, and survival outcomes. Researchers collect data on treatment duration, number of treatment cycles, reasons for discontinuation, and changes in liver function scores. Safety and treatment effectiveness are assessed through clinical evaluations and laboratory tests as part of routine care. Participation lasts up to 2 years, encompassing treatment and follow-up assessments.

First-Line Nivolumab Plus Ipilimumab in Unresectable Hepatocellular Carcinoma (J-PROMISE)