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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
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:
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.
Primary outcome measure(s)
Progression-free survival (PFS) assessed by investigator — Until progression, assessed up to approximately 2 years
Trial sites (1)
Facility
City
Region
Status
Zhongshan Hospital，Fudan University
Shanghai
Shanghai Municipality
More Suzhou Suncadia Biopharmaceuticals Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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