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NOT YET RECRUITING
NCT07490262
PHASE2/PHASE3

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

Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

680

Start Date

2026-03-31

Completion Date

2030-12-31

Last Updated

2026-03-24

Healthy Volunteers

No

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

Locations (1)

The First Affiliated Hosptial of USTC

Hefei, Anhui, China