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A Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced HCC

NCT04720716 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2026-03-19

No results posted yet for this study

Summary

This is a randomized, open-label, controlled, multicenter Phase III study to evaluate the effectiveness and safety of IBI310 combined with sintilimab and sorafenib in patients with locally advanced or metastatic HCC who have not previously received systemic therapy, are unsuitable for radical surgical resection or local treatment, or have had progressive disease after surgical resection or local treatment.

Conditions

Interventions

DRUG

IBI310

IBI310 IV d1, Q6W

DRUG

Sintilimab

sintilimab IV d1, Q3W

DRUG

Sorafenib

Sorafenib 400mg po

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) 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
2021-02-07
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT04720716 on ClinicalTrials.gov