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New immunotherapy combo put to the test in advanced liver cancer

NCT ID NCT07813572

Disease control Sponsor: Suzhou Zelgen Biopharmaceuticals 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are testing whether an experimental immunotherapy called ZG005, combined with bevacizumab, works better than the standard combination of sintilimab and bevacizumab for people with advanced hepatocellular carcinoma who have not yet received systemic treatment. The trial enrolls about 600 adults with unresectable or metastatic liver cancer and compares how long participants live without their cancer worsening, as well as overall survival. Participants receive one of the two drug combinations through an intravenous infusion every three weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ZG005, an experimental immunotherapy drug, given with bevacizumab
What this could lead to
If ZG005 plus bevacizumab works better than the standard combination, it could offer a new first-line option for people with advanced liver cancer.
What could go wrong
This is a phase 3 trial, so the drug's benefit and risks are still being measured. ZG005 may not outperform sintilimab, and combining immunotherapies with bevacizumab can cause serious immune-related side effects.

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

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2032

An estimate. End dates often move.

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 years and older

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: * Participants with histologically/cytologically confirmed unresectable or metastatic advanced HCC; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Barcelona Clinic Liver Cancer stage B, not suitable for local treatment and BCLC C. * At least one measurable lesion based on Recist1.1. * No prior systemic therapy for HCC. * Child-Pugh ≤6 , no history of hepatic encephalopathy. Exclusion Criteria: * Active Central nervous system (CNS) metastasis or leptomeningeal metastases. * Any condition that is not suitable for participate in this study as determined by investigator.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Nanjing Tianyinshan Hospital

    Nanjing, Jiangsu, China

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