Skip to main content
OpenTrials
Completed

NCT Number: NCT04720716

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fudan Universtiy Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically/cytologically confirmed hepatocellular carcinoma, or liver cirrhosis meeting the clinical diagnostic criteria;
  • ECOG performance status score of 0 or 1 point;
  • No systemic antitumor treatment for hepatocellular carcinoma before the first administration;
  • Barcelona Clinic Liver Cancer stage C, or Stage B not suitable for radical surgery and/or local treatment;
  • At least 1 measurable lesion according to RECIST V1.1);
  • Child-Pugh:≤6
  • Adequate organ and bone marrow function.

Exclusion criteria

  • With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
  • Have a history of hepatic encephalopathy or have a history of liver transplantation.
  • With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
  • Central nervous system (CNS) metastasis.
  • Uncontrolled high blood pressure, systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg after optimal medical treatment.
  • Local treatment for liver lesions within 4 weeks.

Treatment and study plan

IBI310

Drug

IBI310 IV d1, Q6W

Sintilimab

Drug

sintilimab IV d1, Q3W

Sorafenib

Drug

Sorafenib 400mg po

Primary outcomes

  1. Overall survival (OS)

    Time frame: up to 24 months after randomization

  2. Objective response rate (ORR)

    Time frame: up to 24 months after randomization

    Objective response rate (ORR) in two arms based on RECIST V1.1 by the IRRC

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: up to 24 months after randomization

    Progression-free survival (PFS) in two arms based on RECIST V1.1 by the IRRC and investigator

  2. Duration of response(DOR)

    Time frame: up to 24 months after randomization

    Duration of response(DOR) in two arms based on RECIST V1.1 by the IRRC and investigator

  3. Disease control rate(DCR)

    Time frame: up to 24 months after randomization

    Disease control rate(DCR) in two arms based on RECIST V1.1 by the IRRC and investigator

  4. Time to progression(TTP)

    Time frame: up to 24 months after randomization

    Time to progression(TTP) in two arms based on RECIST V1.1 by the IRRC and investigator

  5. Time to response(TTR)

    Time frame: up to 24 months after randomization

    Time to response(TTR) in two arms based on RECIST V1.1 by the IRRC and investigator

  6. The incidence and severity of Treatment-Emergent Adverse Events

    Time frame: up to 24 months after randomization

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced Hepatocellular Carcinoma

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2021
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.