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A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment.

Name: A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment. — clinical trial record (NCT07490262)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 2/3

SponsorInnovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Started2026-03-27

View on ClinicalTrials.gov ↗

Amendment history

2026-04-13

Study Status, Contacts/Locations v1

Recruitment opened

Start dateestimated 2026-03-31→confirmed 2026-03-27

Study sites1→2

2026-03-19

Original filing

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

7 trials monitored

See 1 trial at risk

Liver Cancer

1,505 trials monitored

See 60 trials at risk

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.

Trial Details

NCT Number	NCT07490262
Lead Sponsor	Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Conditions	Hepatocellular Carcinoma (HCC)
Enrollment	680 participants
Start Date	2026-03-27
Primary Completion	2027-12-31 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-16