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

NCT ID: NCT06558227

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-24

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

ZG005 10 mg/kg administered intravenously every 3 weeks (Q3w) + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w

Group Type EXPERIMENTAL

ZG005 for Injection

Intervention Type BIOLOGICAL

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

Bevacizumab

Intervention Type BIOLOGICAL

15 mg/kg administered intravenously Q3w

Group B

ZG005 20 mg/kg administered intravenously Q3w + Bevacizumab (Avastin®) 15 mg/kg administered intravenously Q3w

Group Type EXPERIMENTAL

ZG005 for Injection

Intervention Type BIOLOGICAL

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

Bevacizumab

Intervention Type BIOLOGICAL

15 mg/kg administered intravenously Q3w

Group C

Sintilimab 200 mg administered intravenously Q3w + Bevacizumab (达攸同®) 15 mg/kg administered intravenously Q3w

Group Type EXPERIMENTAL

Sintilimab

Intervention Type BIOLOGICAL

200 mg administered intravenously Q3w

Bevacizumab

Intervention Type BIOLOGICAL

15 mg/kg administered intravenously Q3w

Interventions

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ZG005 for Injection

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

Intervention Type BIOLOGICAL

Bevacizumab

15 mg/kg administered intravenously Q3w

Intervention Type BIOLOGICAL

Sintilimab

200 mg administered intravenously Q3w

Intervention Type BIOLOGICAL

Bevacizumab

15 mg/kg administered intravenously Q3w

Intervention Type BIOLOGICAL

Other Intervention Names

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ZG005 Avastin 达攸同

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Wu

Role: STUDY_CHAIR

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Locations

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West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bo Liu

Role: CONTACT

Phone: +86-021-5838-2983

Email: [email protected]

Facility Contacts

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Hong Wu

Role: primary

Other Identifiers

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ZG005-005

Identifier Type: -

Identifier Source: org_study_id