RecruitingPhase 2Phase 3NCT05408221

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

Sponsor

Shandong New Time Pharmaceutical Co., LTD

Enrollment

576 participants

Start Date

Nov 11, 2022

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma

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 .

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — rulonilimab (an immunotherapy) and lenvatinib (a targeted therapy) — for people with advanced liver cancer (hepatocellular carcinoma, or HCC) that cannot be surgically removed. The goal is to evaluate how safe and effective this combination is as a first treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have advanced liver cancer confirmed by biopsy or imaging - Your cancer is stage B or C and is not suitable for surgery or local procedures - You have never received systemic (whole-body) therapy for liver cancer before - Your liver and overall health are in good condition (Child-Pugh A) **You may NOT be eligible if...** - You have already received other treatments for liver cancer - You have serious liver failure or other major organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRulonilimab+Lenvatinib

Rulonilimab, intravenous (i.v.) administration every 3 weeks; Lenvatinib oral administration, once daily

DRUGRulonilimab placebo +Lenvatinib

Rulonilimab placebo, intravenous (i.v.) administration every 3 weeks; Lenvatinib oral administration, once daily

Locations(5)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Huizhou Central People's Hospital

Guandong, China

Jinan Central Hospital

Shandong, China

Linyi Cancer Hospital

Shandong, China

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, China

View Full Details on ClinicalTrials.gov

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NCT05408221

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