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

Last updated: May 12, 2025
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Carcinoma

Treatment

Sintilimab

Bevacizumab

SHR-8068

Clinical Study ID

NCT06618664
SHR-8068-301
  • Ages > 18
  • All Genders

Study Summary

To evaluate the efficacy of SHR-8068 combined with Adebrelimab and Bevacizumab compared with Sintilimab combined with Bevacizumab for the first-line treatment of advanced HCC

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Able and willing to provide a written informed consent

  2. ≥ 18 years old, both male and female

  3. Unresectable locally advanced or metastatic HCC confirmed byhistopathologically/cytologically

  4. At least one measurable lesion based on RECIST v1.1 criteria

  5. Barcelona clinic liver cancer: Stage B or C

  6. No previous systemic antitumor therapy for HCC

  7. ECOG PS of 0-1

  8. Child-Pugh score of A or B7

  9. Expected survival period ≥ 12 weeks

  10. Adequate organ function

  11. Blood pregnancy negative (women of childbearing age) and non-breastfeeding,effective contraception

Exclusion

Exclusion Criteria:

  1. Hepatic cholangiocarcinoma, mixed hepatocellular carcinoma -cholangiocarcinoma,sarcomatoid hepatocellular carcinoma and fibrolamellar hepatocellular carcinoma

  2. Patients with other malignancies currently or within the past 5 years

  3. With known severe allergic reactions to any other monoclonal antibodies

  4. Patients with known CNS metastasis or hepatic encephalopathy

  5. Patients with liver tumor burden greater than 50% of total liver in volume orreceived liver transplants

  6. Patients with symptomatic ascites or pleural effusion

  7. Patients with hypertension which cannot be well controlled by antihypertensives

  8. Uncontrolled cardiac diseases or symptoms

  9. Known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs)

  10. Major vascular disease occurred in the 6 months before randomization

  11. Gastrointestinal perforation or gastrointestinal fistula within 6 months beforerandomization

  12. Major surgery within 28 days before randomization or expected to require majorsurgery during the study period

  13. Active infection, or fever of unknown cause ≥ 38.5℃ in the first 7 days ofrandomization, or WBC > 15×109/L at baseline

  14. Known positive history of human immunodeficiency virus test or acquiredimmunodeficiency syndrome, known HBV infection, known HCV infection

  15. Patients who received live vaccines within 28 days before randomization, or areexpected to be vaccinated during the treatment period

  16. Patients with other potential factors that may affect the study results

Study Design

Total Participants: 590
Treatment Group(s): 4
Primary Treatment: Sintilimab
Phase: 3
Study Start date:
October 28, 2024
Estimated Completion Date:
December 31, 2030

Connect with a study center

  • Anhui Provincial Hospital

    Hefei, Anhui 230000
    China

    Active - Recruiting

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