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NCT Number: NCT07691762

A Study of TACE in Combination With SHR-8068, Adebrelimab, and Bevacizumab Versus TACE in Participants With Incurable Hepatocellular Carcinoma

This is a multicenter, Phase 3 clinical trial to evaluate the efficacy and safety of SHR-8068, Adebrelimab, and Bevacizumab and TACE versus Placebo with TACE in incurable hepatocellular carcinoma.

Participants will continue treatment until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zhongshan Hospital，Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location contact

Jia Fan

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-75 years old, male or female;
  • Diagnosis confirmed HCC by pathologically or clinically;
  • At least one measurable lesion;
  • Child-Pugh liver function grade A;
  • ECOG-PS score: 0 or 1;
  • Eligible for TACE treatment as assessed by the investigator;
  • Participants with HBV or HCV infection must be on and remain on standard antiviral therapy throughout the study period;
  • Consent to contraception

Exclusion criteria

  • Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma; Participants with other malignancies currently or within the past 5 years;
  • Participants with any active, known or suspected autoimmune disorder;
  • Participants with hypertension which cannot be well controlled by antihypertensives;
  • Uncontrolled cardiac diseases or symptoms;
  • Participants with hepatic encephalopathy;
  • Prior esophageal and/or gastric varices bleeding within 6 months prior to initiation of study treatment
  • History of gastrointestinal perforation and/or fistula,
  • Participants with other potential factors that may affect the study results.

Treatment and study plan

SHR-8068+ Adebrelimab+ Bevacizumab

Drug

SHR-8068+ Adebrelimab+ Bevacizumab,intravenous infusion，Transarterial Chemoembolization(TACE)

SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo

Drug

SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo,intravenous infusion，Transarterial Chemoembolization(TACE)

SHR-8068 Placebo +Adebrelimab+ Bevacizumab

Drug

SHR-8068 Placebo +Adebrelimab+ Bevacizumab,intravenous infusion，Transarterial Chemoembolization(TACE)

Primary outcomes

  1. Progression-free survival (PFS) assessed by investigator

    Time frame: Until progression, assessed up to approximately 2 years

Secondary outcomes

  1. Progression-free survival (PFS) assessed by Blinded Independ Review Committee( BIRC)

    Time frame: Until progression, assessed up to approximately 2 years

  2. Overall survival (OS)

    Time frame: Until study completion, assessed up to approximately 2 years

  3. Objective response rate (ORR)

    Time frame: Until study completion,assessed up to approximately 2 years

  4. Disease control rate (DCR)

    Time frame: Until study completion,assessed up to approximately 2 years

  5. Duration of objective tumor response (DoR)

    Time frame: Until study completion,assessed up to approximately 2 years

  6. Adverse events (AEs)

    Time frame: Until study completion,assessed up to approximately 2years

  7. Serious adverse events (SAEs)

    Time frame: Until study completion,assessed up to approximately 3 years

  8. Pharmacokinetics parameters of SHR-8068 、Adebrelimab:serum concentration

    Time frame: Approximately 90 days post-last dose

  9. Immunogenicity indicators of SHR-8068 、Adebrelimab: drug resistant antibody (ADA) and neutralizing antibody (NAb)

    Time frame: Approximately 90 days post-last dose

Study contacts

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

Huan Wang

CONTACT

[email protected]

+86-0518-82342973

Junqin Yang

CONTACT

[email protected]

+86-0518-82342973

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Phase III, Randomized, Double-blind, Multicenter Study of SHR-8068 and Adebrelimab Plus Bevacizumab in Combination With TACE in Participants With Incurable Hepatocellular Carcinoma

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jul 9, 2026
Registry last updated
Jul 9, 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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