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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.

NCT07490262 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2026-04-16

No results posted yet for this study

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.

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

BIOLOGICAL

Bevacizumab

15 mg/kg intravenous infusion, administered on Day 1 of each 3-week treatment cycle

DRUG

Capecitabine

1000 mg/m² orally, administered on Days 1-14 of each 3-week treatment cycle, maximum 4 cycles.

DRUG

Oxaliplatin

85 mg/m² intravenous infusion, administered on Day 1 of each 3-week treatment cycle, maximum 4 cycles.

BIOLOGICAL

IBI310

1 mg/kg intravenous infusion, administered on Day 1 of each 6-week treatment cycle

BIOLOGICAL

Sintilimab

200 mg intravenous infusion, administered on Day 1 of each 3-week treatment cycle

Sponsors & Collaborators

  • Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-27
Primary Completion
2027-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07490262 on ClinicalTrials.gov