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Not yet recruitingNCT07691762Updated Sep 28, 2026

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

A Phase 3 interventional study of SHR-8068 + Adebrelimab + Bevacizumab and SHR-8068 Placebo + Adebrelimab Placebo + Bevacizumab Placebo in Hepatocellular Carcinoma, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
690
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hepatocellular Carcinoma
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma; Participants with other malignancies currently or within the past 5 years;
  2. Participants with any active, known or suspected autoimmune disorder;
  3. Participants with hypertension which cannot be well controlled by antihypertensives;
  4. Uncontrolled cardiac diseases or symptoms;
  5. Participants with hepatic encephalopathy;
  6. Prior esophageal and/or gastric varices bleeding within 6 months prior to initiation of study treatment;
  7. History of gastrointestinal perforation and/or fistula;
  8. Participants with other potential factors that may affect the study results.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
690 participants (estimated)

Study arms

  • Experimental
    Treatment group A

    SHR-8068 + Adebrelimab + Bevacizumab + Transarterial Chemoembolization (TACE)

    Drug: SHR-8068 + Adebrelimab + Bevacizumab

  • Active comparator
    Treatment group B

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

    Drug: SHR-8068 Placebo + Adebrelimab Placebo + Bevacizumab Placebo

  • Experimental
    Treatment group C

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

    Drug: SHR-8068 Placebo + Adebrelimab + Bevacizumab

Interventions

  • DrugSHR-8068 + Adebrelimab + Bevacizumab

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

  • DrugSHR-8068 Placebo + Adebrelimab Placebo + Bevacizumab Placebo

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

  • DrugSHR-8068 Placebo + Adebrelimab + Bevacizumab

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

05

What researchers measure

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 Independent 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 2 years.

  7. Serious adverse events (SAEs)

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

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

    Time frame: Approximately 90 days post-last dose.

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

    Time frame: Approximately 90 days post-last dose.

06

Study locations

2 sites
  • Zhongda Hospital Southeast University
    Nanjing, Jiangsu 210009, China
    • Gaojun Teng · Contact · gjteng@seu.edu.cn · +86-025-83272084
    • Gaojun Teng · Principal investigator
  • Zhongshan Hospital, Fudan University
    Shanghai, Shanghai Municipality 200032, China
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07691762
Lead sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Jul 9, 2026
Start date
Sep 2026 (estimated)
Primary completion
Apr 2031 (estimated)
Completion
Apr 2031 (estimated)
Last update
Sep 28, 2026

Study contacts

Junqin Yang
Contact
junqin.yang@hengrui.com
+86-0518-82342973
Huan Wang
Contact
huan.wang.hw396@hengrui.com
+86-0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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