A Study of TACE in Combination With SHR-8068, Adebrelimab, and Bevacizumab Versus TACE in Participants With Incurable Hepatocellular Carcinoma
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Study ID
- NCT07691762
- Phase
- PHASE3
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- SHR-8068+ Adebrelimab+ Bevacizumab — DRUGSHR-8068+ Adebrelimab+ Bevacizumab,intravenous infusion,Transarterial Chemoembolization(TACE)
- SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo — DRUGSHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo,intravenous infusion,Transarterial Chemoembolization(TACE)
- SHR-8068 Placebo +Adebrelimab+ Bevacizumab — DRUGSHR-8068 Placebo +Adebrelimab+ Bevacizumab,intravenous infusion,Transarterial Chemoembolization(TACE)
Study Details
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.
Key Dates
- First listed
- Jul 9, 2026
- Start date
- Jul 31, 2026
- Status verified
- Jul 2026
- Primary completion
- Apr 30, 2031
- Completion
- Apr 30, 2031
Study Design
- Enrollment
- 690 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment group ASHR-8068+ Adebrelimab+ Bevacizumab +Transarterial Chemoembolization(TACE)
- Active Comparator: Treatment group BSHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo+Transarterial Chemoembolization(TACE)
- Experimental: Treatment group CSHR-8068 Placebo+Adebrelimab+ Bevacizumab +Transarterial Chemoembolization(TACE)
Primary Outcome Measure
Progression-free survival (PFS) assessed by investigator [ Time Frame: Until progression, assessed up to approximately 2 years ]
Central Contacts
- Junqin Yang+86-0518-82342973
- Huan Wang+86-0518-82342973
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