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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients were deemed unsuitable for participating in the study by the investigator for any reasons.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ZG005 for Injection

    Biological/Vaccine

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

  • Bevacizumab

    Biological/Vaccine

    15 mg/kg administered intravenously Q3w

  • Sintilimab

    Biological/Vaccine

    200 mg administered intravenously Q3w

  • Bevacizumab

    Biological/Vaccine

    15 mg/kg administered intravenously Q3w

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Group AExperimental treatment 2 interventions
Group B: Group BExperimental treatment 2 interventions
Group C: Group CExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

progression free survival,PFS

defined as the time from receiving treatment until disease progression or death from any cause, whichever happens first.

Time frame
through study completion, up to 2 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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