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