RecruitingPhase 2NCT06558227

Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in Advanced Hepatocellular Carcinoma

A Multicenter, Randomized, Open-label Phase II Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab for First-line Treatment of Advanced Hepatocellular Carcinoma


Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Enrollment

90 participants

Start Date

Oct 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a randomized, open-label, positive-controlled, multicenter phase II clinical trial. It evaluates the efficacy and safety of ZG005 combined with Bevacizumab compared to Sintilimab combined with Bevacizumab in first-line treatment for patients with advanced hepatocellular carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different immunotherapy combinations for treating advanced liver cancer (hepatocellular carcinoma) that cannot be surgically removed. It tests a new drug called ZG005 combined with bevacizumab (a drug that cuts off blood supply to tumors) against sintilimab (an established immunotherapy) combined with bevacizumab. The goal is to see which combination works better and is safer. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with advanced hepatocellular carcinoma (liver cancer) - You have a good overall health status (ECOG performance score of 0 or 1 — meaning you are fully active or able to carry out light activities) - You are expected to live at least 12 weeks - You have read and fully understood the study and signed the informed consent form **You may NOT be eligible if...** - Your doctor determines for any medical reason that you are not suitable for this study 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

BIOLOGICALZG005 for Injection

10 mg/kg or 20 mg/kg administered intravenously Q3w

BIOLOGICALBevacizumab

15 mg/kg administered intravenously Q3w

BIOLOGICALSintilimab

200 mg administered intravenously Q3w

BIOLOGICALBevacizumab

15 mg/kg administered intravenously Q3w


Locations(1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

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NCT06558227


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