Low-dose Bevacizumab Plus Adebrelimab Combined With TACE-HAIC for Unresectable HCC
Summary
A single-arm Phase 2 clinical trial (NCT07543783) has been registered as of April 22, 2026, enrolling 38 participants with unresectable hepatocellular carcinoma (HCC) to evaluate the efficacy and safety of low-dose bevacizumab (7.5 mg/kg, Q3W) plus adebrelimab (1200 mg, Q3W) combined with transarterial chemoembolization (TACE) followed by hepatic arterial infusion chemotherapy (HAIC) using the FOLFOX regimen as first-line treatment. The study, sponsored by the Third Affiliated Hospital of Sun Yat-sen University, uses Simon's two-stage optimal design (alpha=0.05, power=0.8) with objective response rate (ORR) per RECIST v1.1 as the primary endpoint.
“A total of 38 participants will be enrolled using Simon's two-stage optimal design (alpha=0.05, power=0.8).”
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This ClinicalTrials.gov registry entry documents a single-arm Phase 2 study (NCT07543783) investigating the combination of low-dose bevacizumab and adebrelimab with TACE followed by HAIC FOLFOX as first-line treatment for unresectable hepatocellular carcinoma. The trial will enroll 38 participants using Simon's two-stage optimal design and assess objective response rate as the primary endpoint, with secondary endpoints including progression-free survival, disease control rate, duration of response, overall survival, and safety. The study is sponsored by the Third Affiliated Hospital of Sun Yat-sen University, with adebrelimab provided free of charge for two years by Shanghai Shengdi Pharmaceutical Co., Ltd. As a registry entry, this document does not create compliance obligations for pharmaceutical manufacturers, healthcare providers, or other regulated entities beyond standard clinical trial registration requirements.
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Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Low-dose Bevacizumab Plus Adebrelimab Combined With Transarterial Chemoembolization Followed by TACE-HAIC
Phase 2 NCT07543783 Kind: PHASE2 Apr 22, 2026
Abstract
his is a single-arm, phase II clinical study evaluating the efficacy and safety of low-dose bevacizumab (7.5 mg/kg, Q3W) plus adebrelimab (1200 mg, Q3W) combined with transarterial chemoembolization (TACE) followed by hepatic arterial infusion chemotherapy (HAIC) with the FOLFOX regimen as first-line treatment for patients with unresectable hepatocellular carcinoma (HCC). Eligible participants will receive TACE followed by HAIC (oxaliplatin, leucovorin, and fluorouracil) and subsequent intravenous administration of adebrelimab and low-dose bevacizumab every 3 weeks. The primary endpoint is objective response rate (ORR) assessed by investigators per RECIST v1.1. Secondary endpoints include progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), overall survival (OS), and safety. A total of 38 participants will be enrolled using Simon's two-stage optimal design (alpha=0.05, power=0.8). The study is sponsored by the Third Affiliated Hospital of Sun Yat-sen University. Adebrelimab is provided free of charge for two years by Shanghai Shengdi Pharmaceutical Co., Ltd.
Conditions: Adebrelimab (SHR-1316), Bevacizumab, Hepatocellular Carcinoma (HCC)
Interventions: Transarterial Chemoembolization (TACE), Hepatic Arterial Infusion Chemotherapy (HAIC, FOLFOX), Adebrelimab, Low-dose Bevacizumab
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