Phase Ⅱ/III Studies to Investigate the Efficacy and Safety of Rulonilimab in Combination With Lenvatinib Compared to Placebo in Combination With Lenvatinib as First-Line Therapy in Subjects With Hepatocellular Carcinoma (HCC)

• Status: Not yet recruiting
• Trial end date: 2026-08-01

Summary

There are two studies included in this protocol. One is an open-label Phase Ⅱ study designed to evaluate the tolerability and safety of lenvatinib in combination with Rulonilimab in participants with hepatocellular carcinoma (HCC). The other is a multi-center, double-blind, randomized, phase III study to investigate the efficacy and safety of Rulonilimab in combination with lenvatinib and placebo in combination with lenvatinib in the treatment of subjects with no prior systemic treatment and with unresectable advanced hepatocellular carcinoma (HCC).

• Phase: Phase 2/Phase 3

Details

• Lead Sponsor: Shandong New Time Pharmaceutical Co., LTD
• Treatments: Lenvatinib