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Not Yet Recruiting NCT07691762

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

Conditions: Hepatocellular Carcinoma

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 690
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Location: Zhongshan Hospital,Fudan University Shanghai Shanghai Municipality

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07691762). StuddyBuddy aggregates publicly available trial information.