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

Recruiting Phase 2 Phase 3 Interventional Study
Hepatocellular Carcinoma (HCC)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
680 (estimated)
Sponsor
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Industry
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About This Trial
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 the…
Trial Locations
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Eligibility Criteria
Inclusion criteria: 1. Histologically or cytologically confirmed hepatocellular carcinoma (HCC). 2. Age ≥18 years and ≤75 years. 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1. 4. Barcelona Clinic Liver Cancer (BCLC) staging of Stage C, or Stage B that is unsuita…
Contacts

Haiyun Zuo

021-31852088

Haiyun.zuo@innoventbio.com

CONTACT