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New combo therapy shows promise in liver cancer battle

NCT ID NCT04720716

Disease control Sponsor: Innovent Biologics (Suzhou) Co. Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new combination of two drugs (IBI310 and sintilimab) against the standard drug sorafenib for people with advanced liver cancer who had not received prior treatment. The goal was to see if the combination could help patients live longer or shrink tumors more effectively. 344 participants took part in this Phase 3 trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

344 people

The number who actually took part.

Started

Feb 2021

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically/cytologically confirmed hepatocellular carcinoma, or liver cirrhosis meeting the clinical diagnostic criteria; 2. ECOG performance status score of 0 or 1 point; 3. No systemic antitumor treatment for hepatocellular carcinoma before the first administration; 4. Barcelona Clinic Liver Cancer stage C, or Stage B not suitable for radical surgery and/or local treatment; 5. At least 1 measurable lesion according to RECIST V1.1); 6. Child-Pugh:≤6 7. Adequate organ and bone marrow function. Exclusion Criteria: 1. With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues. 2. Have a history of hepatic encephalopathy or have a history of liver transplantation. 3. With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion. 4. Central nervous system (CNS) metastasis. 5. Uncontrolled high blood pressure, systolic blood pressure \>140mmHg or diastolic blood pressure \>90mmHg after optimal medical treatment. 6. Local treatment for liver lesions within 4 weeks.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatocellular carcinoma

Contacts and locations

Locations

  • Fudan Universtiy Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.