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ZG005 Plus Bevacizumab vs Sintilimab Plus Bevacizumab as First-Line Therapy for Advanced Hepatocellular

ConditionHepatocellular Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd

About this trial

The purpose of the study is to evaluate the efficacy of ZG005 combined with bevacizumab compared with sintilimab combined with bevacizumab in the first-line treatment of participants with advanced HCC

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with histologically/cytologically confirmed unresectable or metastatic advanced HCC;

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Barcelona Clinic Liver Cancer stage B, not suitable for local treatment and BCLC C.

At least one measurable lesion based on Recist1.1.

Disqualifiers

Active Central nervous system (CNS) metastasis or leptomeningeal metastases.

Any condition that is not suitable for participate in this study as determined by investigator.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ZG005 for Injection

    Drug

    Participants receive ZG005 20 mg/kg IV, Q3W

  • Bevacizumab ( Avastin)

    Drug

    Participants receive Bevacizumab ( Avastin) 15 mg/kg IV, Q3W

  • Sintilimab

    Drug

    Participants receive Sintilimab 200mg IV, Q3W

  • Bevacizumab

    Drug

    Participants receive Bevacizumab 15 mg/kg IV, Q3W

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: ZG005+BevacizumabExperimental treatment 2 interventions
Group B: Sintilimab Plus BevacizumabActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

PFS evaluated by the Blinded Independent Review Committee (IRC) based on RECIST V1.1

Time frame
up to 3 years
2

Overall survival (OS)

Time frame
up to 5 years

Secondary outcomes

1

PFS

PFS evaluated by investigator based on RECIST V1.1

Time frame
up to 3 years
2

Objective response rate (ORR)

ORR evaluated by IRC based on RECIST V1.1

Time frame
up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: