Chemo-loaded microspheres aim to starve liver tumors from within

NCT ID NCT05911633

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This trial tests a treatment for people with liver cancer that cannot be removed by surgery. Tiny beads called BioPearl microspheres are loaded with the chemotherapy drug doxorubicin and injected into the blood vessels feeding the tumor. The beads block blood flow and release the drug directly into the cancer. The study will check how safe this is and whether it can shrink or control the tumors.

What this could mean

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

Active substance
doxorubicin-loaded BioPearl microspheres
What this could lead to
If successful, this could offer a safe and effective way to deliver chemotherapy directly to liver tumors, potentially improving tumor control without major surgery.
What could go wrong
This is a small, single-arm study with no comparison group, so results may not be definitive. Risks include side effects from the chemotherapy or procedure, such as liver damage or bleeding.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

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

Started

Feb 2024

Expected to finish

Dec 2027

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: 1. Subject is at least 18 years old 2. Subject with HCC confirmed by histology or according to the latest applicable version of EASL (the European Association for the Study of the Liver) criteria 3. Subject with tumor(s) \< 5 cm and within the up-to-7 criteria: the sum of the diameter of the largest tumor (in cm) and the number of tumors must be ≤ 7.0 4. Subject with BCLC (Barcelona Clinic Liver Cancer) Stage A or B classification who is not a candidate for curative treatment at the time of study inclusion 5. Subject with treatment failure/recurrence after a prior resection/ablation is permitted, with the exception of recurrence in the segment of a prior thermal ablation 6. WHO (World Health Organization) or ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1 7. Subject deemed treatable in one session for initial treatment 8. Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh Class A) 9. Total bilirubin ≤ 2.0 mg/dl 10. Adequate bone marrow function: Hemoglobin ≥ 9g/dl, absolute neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 75 x 109/L 11. Subject with no ascites or with minor ascites controlled by sodium dietary restrictions (subject receiving diuretic treatment or paracentesis is not eligible) 12. Adequate renal function: serum creatinine \< 1.5 X ULN (Upper Limit of Normal) 13. Subject has provided written informed consent 14. Subjects of childbearing/reproductive potential should use adequate birth control measures, during the study treatment period until survival follow-up Exclusion Criteria: 1. Subject previously treated with any systemic therapy for HCC 2. Subject previously treated with intra-arterial loco-regional therapy for HCC 3. Eligible for curative treatment at the time of study inclusion 4. Recurrence in the segment of a prior thermal ablation 5. Advanced liver disease: Child-Pugh's B-C class or active gastrointestinal bleeding, encephalopathy 6. Advanced tumoral disease: BCLC class C or D (vascular invasion - even segmental, extra-hepatic spread or cancer-related symptoms performance status \>1) 7. History of another primary tumor. Exceptions include: A. Malignancy treated with curative intent ≥ 5 years before inclusion and with no known active disease B. Malignancy which occurred \< 5 years before, not active and not expected to recur or be clinically relevant in the next 5 years 8. Subject with history of biliary tree disease or biliary dilatation 9. Portal vein thrombosis, porto-systemic shunt, hepatofugal blood flow or absent portal blood flow in the liver area to be treated 10. Contraindication to multiphasic CT and MRI (e.g. allergy to contrast media) 11. Any other contraindication for embolization procedure or Doxorubicin treatment 12. Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints Note: Trials requiring extended follow-up for products that were investigational, but have become commercially available since then, are not considered investigational trials 13. In the Investigator's opinion subject has (a) co-morbid condition(s) that could limit the subject's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study 14. Pregnant or breast-feeding woman

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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

    10 sites in 4 countries. 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

  • Beaujon Hospital

    RECRUITING

    Clichy, France

  • CHU Grenobles (Hôpital Michallon)

    NOT_YET_RECRUITING

    La Tronche, France

  • CUB Hôpital Erasme

    RECRUITING

    Brussels, Belgium

  • Città della Salute e della Scienza di Torino

    RECRUITING

    Turin, Italy

  • Fondazione IRCCS Instituto Tumori

    RECRUITING

    Milan, Italy

  • Fondazione Policlinico Universitario A. Gemelli

    RECRUITING

    Rome, Italy

  • Paul-Brousse Hospital

    RECRUITING

    Villejuif, France

  • SLK-Kliniken Heilbronn

    RECRUITING

    Heilbronn, Germany

  • UZ Leuven

    RECRUITING

    Leuven, Belgium

  • University Hospital Tübingen

    RECRUITING

    Tübingen, Germany

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