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

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

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.

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.