Clinical Trial

SHR-1701 Plus Apatinib for Second-Line Treatment in Targeted-Immune Pretreated Advanced Hepatocellular Carcinoma

Not Yet Recruiting Phase 2
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Summary
This clinical study aims to evaluate the efficacy and safety of Retlirafusp alfa Injection (SHR-1701) combined with apatinib in patients with advanced hepatocellular carcinoma (HCC) who have experienced disease progression after first-line targeted combined immunotherapy, and provide clinical evidence for the second-line treatment of advanced HCC. A total of 80 patients with radiologically or pathologically confirmed advanced/unresectable hepatocellular carcinoma with disease progression after prior first-line targeted-immunotherapy will be enrolled within 2.5 years. All enrolled patients will receive intravenous infusion of SHR-1701 at 30 mg/kg every 3 weeks in combination with oral apatinib 250 mg once daily; treatment will be maintained until disease progression or intolerable adverse toxicity occurs. The primary study endpoint is objective response rate (ORR).
Trial Details
NCT Number NCT07749859
Lead Sponsor Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions Advanced Unresectable Hepatocellular Carcinoma
Enrollment 80 participants
Start Date 2026-08
Primary Completion 2028-07 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-06