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New quadruple therapy targets liver cancer and diabetes together

NCT ID NCT07557914

Disease control Sponsor: Haibo Shao 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 21, 2026 · Updated 1 time

Summary

This study tests a combination of four drugs (epalrestat, HAIC, donafenib, and tislelizumab) as a first treatment for people with advanced liver cancer that cannot be removed by surgery and who also have diabetes. The goal is to see if this approach can control the cancer for at least 12 months without major side effects. About 32 participants will take part in this early-phase 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 2

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

Participants

About 32 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

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 to 80 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. Diabetes mellitus combined with unresectable advanced HCC (BCLC stage C); 2. Patients who have the need for treatment, prevention and improvement of diabetic neuropathy; 3. Liver function at Child-Pugh grade A or B (≤ 7 points), ECOG PS 0-1; 4. Age 18-80 years old. Confirmed as unrectable HCC through pathological or imaging diagnosis; Exclusion Criteria: 1. Severe liver dysfunction: Child-Pugh C grade (≥ 8 points) or active hepatic encephalopathy Illness; 2. Extensive extrahepatic metastases (e.g., lung, bone, or peritoneum metastases); 3. Severe cardiovascular diseases: Uncontrolled heart failure, recent myocardial infarction; 4. Renal failure: Creatinine clearance rate \< 30 mL/min; 5. Thrombocytopenia (less than 50×10⁹/L) or coagulation dysfunction (INR greater than 1.5); 6. Active infection (such as uncontrolled hepatitis B virus replication with HBV-DNA \> 2000 IU/mL); 7. ECOG PS ≥ 2 or extremely poor overall condition; 8. Diabetic patients with acute ketoacidosis or during the period of severe infection; 9. Pregnant and lactating women; 10. Known history of other malignancy.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus hepatocellular carcinoma

As listed by the trial registrant

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

Diabetes HCC - 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

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110000, China

More trials for these conditions

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