NCT05911633 BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
| NCT ID | NCT05911633 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Terumo Europe N.V. |
| Condition | Hepatocellular Carcinoma Non-resectable |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-02-27 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-02-27 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of the study is to confirm safety and technical success of BioPearl™ microspheres loaded with Doxorubicin in the treatment of unresectable hepatocellular carcinoma (HCC). The secondary objective of the study is to investigate the efficacy of BioPearl™ microspheres loaded with Doxorubicin in the treatment of subjects with unresectable HCC.
Eligibility Criteria
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
Contact & Investigator
Marie-Pierre Dewez
STUDY DIRECTOR
Terumo Europe EMCD
Frequently Asked Questions
Who can join the NCT05911633 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma Non-resectable. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05911633 currently recruiting?
Yes, NCT05911633 is actively recruiting participants. Contact the research team at tamara.sals@terumo-europe.com for enrollment information.
Where is the NCT05911633 trial being conducted?
This trial is being conducted at Brussels, Belgium, Leuven, Belgium, Clichy, France, La Tronche, France and 6 additional locations.
Who is sponsoring the NCT05911633 clinical trial?
NCT05911633 is sponsored by Terumo Europe N.V.. The principal investigator is Marie-Pierre Dewez at Terumo Europe EMCD. The trial plans to enroll 50 participants.
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