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New cocktail of drugs and procedure aims to stop liver cancer in its tracks

NCT ID NCT07150377

Disease control Sponsor: The Second Affiliated Hospital of Shandong First Medical University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2 trial is testing a combination of two immunotherapy drugs (iparomlimab and tuvonralimab), a targeted therapy (lenvatinib), and a procedure that blocks the tumor's blood supply (TACE) in 41 people with advanced liver cancer. The goal is to see if this mix can keep the cancer from growing longer than current treatments. Participants will be divided into two groups: those who have never had systemic therapy and those who have had prior treatment.

What this could mean

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

Active substance
iparomlimab, tuvonralimab, lenvatinib, and transarterial chemoembolization (TACE)
What this could lead to
If successful, this combination could offer a new treatment option to slow or shrink advanced liver cancer, potentially extending life without the disease getting worse.
What could go wrong
This is a small, early-phase trial with no control group, so results may not be definitive. The combination of drugs and TACE may cause significant side effects, and the benefit over standard care is unknown.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 41 people

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

Expected to start

Aug 2025

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * First-line Cohort: 1. Confirmed diagnosis of hepatocellular carcinoma (HCC), aged \> 18 years. No prior systemic therapy. 2. Child-Pugh class A/B at baseline. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment. 4. Measurable lesions per modified Response Evaluation Criteria in Solid Tumors (mRECIST). 5. Adequate organ and bone marrow function. Second-line Cohort: 1. Confirmed diagnosis of HCC, aged \> 18 years. 2. Prior first-line therapy (including targeted therapy or immunotherapy). 3. Child-Pugh class A/B at baseline. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment. 5. Measurable lesions per modified Response Evaluation Criteria in Solid Tumors (mRECIST). 6. Adequate organ and bone marrow function. Exclusion Criteria: 1. Concomitant hepatic encephalopathy. 2. History of any nephrotic syndrome. 3. History of clinically significant cardiovascular disease or arterial thromboembolic events, including stroke, myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization. 4. Evidence of any prior or current coagulopathy or bleeding diathesis, or any type of surgery performed within the past 28 days (biopsy is not excluded). 5. History of abdominal fistula, gastrointestinal perforation, refractory non-healing gastric ulcer, or active gastrointestinal bleeding within 6 months prior to randomization. 6. Main portal vein thrombosis visible on baseline imaging. 7. Pleural or peritoneal effusion requiring clinical intervention. 8. Gastroesophageal varices. 9. Portal vein invasion (VP3 or VP4).

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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 (HCC)

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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