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NCT Number: NCT06618664

A Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab or Atezolizumab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma

THis study aims to evaluate the efficacy of SHR-8068 combined with Adebrelimab and Bevacizumab compared with Sintilimab or Atezolizumab combined with Bevacizumab for the first-line treatment of advanced HCC.

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Key information

Conditions

Advanced Hepatocellular Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able and willing to provide a written informed consent.
  • ≥ 18 years old, both male and female.
  • Unresectable locally advanced or metastatic HCC confirmed by histopathologically/cytologically.
  • At least one measurable lesion based on RECIST v1.1 criteria.
  • Barcelona clinic liver cancer: Stage B or C.
  • No previous systemic antitumor therapy for HCC.
  • ECOG PS of 0-1.
  • Child-Pugh score of A or B7.
  • Expected survival period ≥ 12 weeks.
  • Adequate organ function.
  • Blood pregnancy negative (women of childbearing age) and non-breastfeeding, effective contraception.

Exclusion criteria

  • Hepatic cholangiocarcinoma, mixed hepatocellular carcinoma -cholangiocarcinoma, sarcomatoid hepatocellular carcinoma and fibrolamellar hepatocellular carcinoma.
  • Patients with other malignancies currently or within the past 5 years.
  • With known severe allergic reactions to any other monoclonal antibodies.
  • Patients with known CNS metastasis or hepatic encephalopathy.
  • Patients with liver tumor burden greater than 50% of total liver in volume or received liver transplants.
  • Patients with symptomatic ascites or pleural effusion.
  • Patients with hypertension which cannot be well controlled by antihypertensives.
  • Uncontrolled cardiac diseases or symptoms.
  • Known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs).
  • Major vascular disease occurred in the 6 months before randomization.
  • Gastrointestinal perforation or gastrointestinal fistula within 6 months before randomization.
  • Major surgery within 28 days before randomization or expected to require major surgery during the study period.
  • Active infection, or fever of unknown cause ≥ 38.5℃ in the first 7 days of randomization, or WBC > 15×109/L at baseline.
  • Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known HBV infection, known HCV infection.
  • Patients who received live vaccines within 28 days before randomization, or are expected to be vaccinated during the treatment period
  • Patients with other potential factors that may affect the study results.

Treatment and study plan

SHR-8068

Drug

SHR-8068: injection, 50 mg/10 mL, intravenous infusion

Adebrelimab

Drug

Adebrelimab: injection, 600 mg/12 mL, intravenous infusion

Bevacizumab

Drug

Bevacizumab: injection, 100 mg/4 mL, intravenous infusion

Sintilimab

Drug

Sintilimab: injection, 100 mg/10 mL, intravenous infusion

Atezolizumab Injection

Drug

Atezolizumab injection.

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)

  2. Overall survival (OS)

    Time frame: From randomization to death from any cause (whichever occurs first) (up to approximately 36 months)

    OS is defined as the time from randomization to death from any cause.

Secondary outcomes

  1. Time to Progression (TTP)

    Time frame: From randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)]

    TTP is defined as the time from randomization to the until first evidence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1.

  2. Disease Control Rate (DCR)

    Time frame: From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)

    DCR is defined as the proportion of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD), as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1.

  3. Objective Response Rate (ORR)

    Time frame: From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 36 months)

    ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR), as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1.

  4. Duration of Response (DoR)

    Time frame: From the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 36 months)

    DOR is defined as the time from the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first).

  5. Time to Response (TTR)

    Time frame: From the first occurrence of complete response (CR) or partial response (PR) as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)

    TTR is defined as time from the randomization of Complete Response (CR) or Partial Response (PR) by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1.

  6. The incidence, severity and relevance to investigational drugs of adverse events (AE) and serious adverse events (SAE) according to NCI-CTCAE v5.0

    Time frame: From the ICF date until the end of the safety follow-up or initiation of new anti-tumor therapy (up to approximately 36 months)

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Shi

CONTACT

[email protected]

+86-0518-82342973

Ying Sun

CONTACT

[email protected]

+86-0518-82342973

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Study of Anti CTLA-4 Antibody SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab or Atezolizumab Combined With Bevacizumab for the First-line Treatment of Advanced Hepatocellular Carcinoma

Important dates

Study start
2024
Primary completion
2026
Study completion
2030
First posted
Oct 1, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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