Chemo-loaded microspheres aim to starve liver tumors from within
NCT ID NCT05911633
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
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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
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
10 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Beaujon Hospital
RECRUITINGClichy, France
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CHU Grenobles (Hôpital Michallon)
NOT_YET_RECRUITINGLa Tronche, France
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CUB Hôpital Erasme
RECRUITINGBrussels, Belgium
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Città della Salute e della Scienza di Torino
RECRUITINGTurin, Italy
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Fondazione IRCCS Instituto Tumori
RECRUITINGMilan, Italy
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Fondazione Policlinico Universitario A. Gemelli
RECRUITINGRome, Italy
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Paul-Brousse Hospital
RECRUITINGVillejuif, France
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SLK-Kliniken Heilbronn
RECRUITINGHeilbronn, Germany
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UZ Leuven
RECRUITINGLeuven, Belgium
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University Hospital Tübingen
RECRUITINGTübingen, Germany
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Other studies related to the condition(s) this trial covers.
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- Can adding a fourth drug shrink large liver tumors that invade the portal vein?
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- New combo therapy aims to stop liver cancer in its tracks
- New combo therapy aims to shrink liver tumors in Hard-to-Treat patients