Completed

IBI310 and Sintilimab Combination for Advanced Hepatocellular Carcinoma Treatment

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Study Aim

This study aims to evaluate the effectiveness of a combined treatment using IBI310 and Sintilimab in adults with advanced hepatocellular carcinoma, focusing on the objective response rate and overall survival.

What is being tested

IBI310

+ Sintilimab

+ Sorafenib

Drug
Who is being recruted

Adenocarcinoma+8

+ Carcinoma

+ Digestive System Diseases

From 18 to 75 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: February 2021
See protocol details

Summary

Principal SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 7, 2021

Actual date on which the first participant was enrolled.

This clinical trial is a Phase III study that focuses on treating advanced hepatocellular carcinoma (HCC), a type of liver cancer. The study aims to compare the effectiveness and safety of two different treatment approaches. One approach involves a combination of IBI310 and sintilimab, while the other uses a drug called sorafenib. The study is designed for patients who have not received systemic therapy before, are not suitable for surgery or local treatment, or have experienced disease progression after such treatments. The main goal is to find a better treatment option that can improve the care for patients with advanced HCC. During the study, participants are randomly assigned to receive either the combination of IBI310 and sintilimab or sorafenib. The study measures the results by looking at the objective response rate, which indicates how well the tumor responds to the treatment, and overall survival, which considers how long patients live after the treatment. These measurements help determine which treatment approach is more effective and safer for patients with advanced HCC.

Official TitleA 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
NCT04720716
Principal SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

344 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsCarcinoma, HepatocellularLiver DiseasesLiver NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and Epithelial

Criteria

7 inclusion criteria required to participate
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
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6 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Fudan Universtiy Zhongshan Hospital

Shanghai, ChinaOpen Fudan Universtiy Zhongshan Hospital in Google Maps
CompletedOne Study Center