A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patie… (NCT07490262) | Clinical Trial Compass
RecruitingPhase 2/3
A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment.
China680 participantsStarted 2026-03-27
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed hepatocellular carcinoma (HCC).
✓. Age ≥18 years and ≤75 years.
✓. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
✓. Barcelona Clinic Liver Cancer (BCLC) staging of Stage C, or Stage B that is unsuitable for curative-intent surgery and/or locoregional therapy.
✓. No prior systemic antineoplastic therapy for HCC before first dose.
✓. At screening, per RECIST 1.1, there must be at least one measurable lesion that has not undergone local therapy, or a measurable lesion that has clearly progressed following local therapy (per RECIST 1.1).
✓. Child-Pugh score ≤7.
✓. Adequate organ and bone marrow function.
Exclusion criteria
✕. Histologically or cytologically confirmed diagnosis of fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, cholangiocarcinoma, or other mixed hepatic malignancies containing these components.
What they're measuring
1
Phase II: ORR （Objective Response Rate） assessed by investigator per RECIST 1.1.
Timeframe: up to 2 years
2
Phase II: PFS（Progression-Free Survival） assessed by investigator per RECIST 1.1.
✕. History of hepatic encephalopathy or prior liver transplantation.
✕. Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring therapeutic drainage; participants with only minimal (radiologically detected), asymptomatic effusions may be enrolled.
✕. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection:
✕. Known central nervous system (CNS) metastases or symptomatic spinal cord compression.
✕. Esophageal or gastric variceal bleeding due to portal hypertension within the past 6 months; Grade 3 (G3) esophageal/gastric varices documented by endoscopy within 3 months prior to first dose; or evidence of portal hypertension.
✕. Life-threatening hemorrhagic event within the past 3 months, including but not limited to events requiring blood transfusion, surgical or local intervention, or ongoing pharmacologic hemostatic therapy.
✕. Metastatic lesions invading major vessels, airways, or the mediastinum with clinically significant bleeding risk.