NCT05408221

the Efficacy and Safety of Rulonilimab in Combination With Lenvatinib in Hepatocellular Carcinoma

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 576 (estimated)
• Sponsor: Shandong New Time Pharmaceutical Co., LTD · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

There are two studies included in this protocol. One is an open-label Phase Ⅱ study . The other is a multi-center, double-blind, randomized, phase III study .

Detailed description

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).

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Rulonilimab+Lenvatinib	Rulonilimab, intravenous (i.v.) administration every 3 weeks; Lenvatinib oral administration, once daily
DRUG	Rulonilimab placebo +Lenvatinib	Rulonilimab placebo, intravenous (i.v.) administration every 3 weeks; Lenvatinib oral administration, once daily

Timeline

• Start date: 2022-11-11
• Primary completion: 2025-08-01
• Completion: 2026-08-01
• First posted: 2022-06-07
• Last updated: 2023-03-10

Locations

5 sites across 1 country: China