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New immunotherapy aims to fight advanced liver cancer

NCT ID NCT05033522

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests an immunotherapy called AlloStim against standard treatments (sorafenib, lenvatinib, or chemotherapy) in 150 Asian adults with advanced liver cancer that cannot be treated with surgery or local therapies. Participants are randomly assigned to receive either AlloStim or a standard drug. The main goal is to see if AlloStim improves overall survival and quality of life.

What this could mean

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

Active substance
AlloStim immunotherapy
What this could lead to
If it works, this could offer a new immunotherapy option for advanced liver cancer patients who have few alternatives.
What could go wrong
The trial is suspended, so results are uncertain. It is still early and may not show a survival benefit over existing drugs.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 150 people

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

Started

Aug 2023

Expected to finish

Dec 2026

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 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. Males and females who are at least 18 years of age at time of enrollment 2. Histologically or cytologically documented advanced HCC (BCLC stage C) disease at diagnosis. 3. No prior treatment for BCLC class C disease. 4. Child-Pugh Class A or subset of Child-Pugh Class B 5. Performance status: ECOG \< 2 with no deterioration over the previous 2 weeks 6. With or without positive HBV and/or HCV 7. With or without extrahepatic disease and with or without macrovascular invasion 8. Measurable enhancing disease in liver with at least one target lesion evaluable by mRECIST 9. Adequate hematological, liver and renal function as assessed by the following: * Hemoglobin \> 10.0 g/dl * Platelet count \> 75,000/μl * ALT and AST \< 5.0 x ULN * Serum creatinine \< 1.5 10. Women of child-bearing potential: negative pregnancy test 11. Patients of child producing potential: usage of contraception or avoidance of pregnancy measures while enrolled on study 12. Ability to understand the study, its inherent risks, side effects and potential benefits and ability to give written informed consent to participate Exclusion Criteria: 1. Any prior cancer diagnosis (other than cured basal cell carcinoma, head and neck carcinoma in-situ, or superficial Ta, Tis, T1 bladder cancer) or concurrent cancer histologically different than HCC (e.g., cholangiocarcinoma). 2. Child-Pugh liver function combined score \>9 (Class C or Class D) 3. Moderate uncontrolled or severe ascites (+3 on Child-Pugh calculator) 4. Clinical symptoms of hepatic decompensation or presence of hepatic encephalopathy 5. Severe stomach/esophageal varices requiring interventional treatment. 6. Unable to tolerate radiological contrast dye 7. Any prior experimental, approved or off-label treatment for HCC (including levantinib, nivolumab, duvalumab, tremelimumab, brivananib, cabozantinib or ramucircumab) or any approved or experimental procedures such as surgery, radiation or ablation. 8. Enrollment in any previous clinical trial for HCC 9. Any history of autoimmune disorder (type I, insulin-dependent diabetes allowed) 10. History of COPD or oxygen saturation \<92% at room air 11. Any clinical condition requiring systemic steroids (inhaled steroids allowed) or any current immunosuppressive therapy or anti-epileptic drug therapy. 12. Known history of HIV infection 13. Clinically significant gastrointestinal bleeding within 30 days prior to study entry 14. History of cardiac disease: congestive heart failure \> NYHA class 2; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or Digoxin are permitted) 15. Uncontrolled hypertension (SBP \>150 or DBP\>90). 16. Active clinically serious infections (\> grade 2 CTCAE version 5.0) 17. History of organ transplant or tissue allograft 18. Uncontrolled concurrent serious medical or psychiatric illness 19. Clinically apparent central nervous system metastases or carcinomatous meningitis 20. History of drug abuse or current alcohol abuse 21. History of blood transfusion reactions 22. Pregnant or lactating women

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    8 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Chiangmai University

    Chiang Mai, Thailand

  • Columbia Asia Bukit Rimau

    Shah Alam, Selangor, 40460, Malaysia

  • Naresuan University Hospital

    Phitsanulok, Tha Pho, 65000, Thailand

  • Prince of Songkla University (Songklanagarind Hospital)

    Hat Yai, Changwat Songkhla, 90110, Thailand

  • Siriraj Hospital

    Bangkok Noi, Bangkok, 10700, Thailand

  • Songklanagarind Hospital

    Khon Kaen, Thailand

  • Sultan Ismail Hospital

    Johor Bahru, Johor, 81100, Malaysia

  • Sultanah Bahiyah Hospital

    Alor Star, Kedah, 05460, Malaysia

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