clinical trial · NCT07490262
A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment.
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.·phase3·recruiting·n = 680
Hepatocellular Carcinoma (HCC)BevacizumabCapecitabineOxaliplatinIBI310Sintilimab
brief summary
This study is a randomized, controlled, open-label, multicenter, seamless Phase II/III trial designed to evaluate the efficacy and safety of the combination regimen of IBI310 and sintilimab in participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who are: (1) treatment-naive to systemic therapy; and (2) either unsuitable for curative-intent surgical resection or local therapy, or have experienced disease progression following prior surgical resection or local therapy.
started
Mar 27, 2026
primary completion
Dec 31, 2027
completion
Dec 31, 2030
last updated
Apr 16, 2026
official title
A Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy as First-line Treatment in Previously Untreated Patients With Unresectable or Metastatic Hepatocellular Carcinoma
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol