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

NCT ID: NCT06558227

Condition: Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: ZG005 for Injection
Description: 10 mg/kg or 20 mg/kg administered intravenously Q3w
Arm group label: Group A
Arm group label: Group B

Other name: ZG005

Intervention type: Biological
Intervention name: Bevacizumab
Description: 15 mg/kg administered intravenously Q3w
Arm group label: Group A
Arm group label: Group B

Other name: Avastin

Intervention type: Biological
Intervention name: Sintilimab
Description: 200 mg administered intravenously Q3w
Arm group label: Group C

Intervention type: Biological
Intervention name: Bevacizumab
Description: 15 mg/kg administered intravenously Q3w
Arm group label: Group C

Other name: 达攸同

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Fully understand the study and voluntarily sign the informed consent form. - 18-75 years of age; - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; - Life expectancy ≥ 12 weeks. Exclusion Criteria: - Patients were deemed unsuitable for participating in the study by the investigator for any reasons.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: West China Hospital of Sichuan University

Address:
City: Chengdu
Country: China

Contact:
Last name: Hong Wu

Start date: September 2024

Completion date: October 2026

Lead sponsor:
Agency: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Agency class: Industry

Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06558227

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