Treatment of unresectable liver cancer using BioPearl™ microspheres with Doxorubicin
BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC): Prospective, Single Arm, Multi-center, Post-Market Clinical Follow-up (PMCF) Study
This study is testing if a new treatment using BioPearl™ microspheres with Doxorubicin can help people with liver cancer that can't be surgically removed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Terumo Europe N.V. Industry-sponsored |
| Drugs / interventions | Doxorubicin |
| Locations | 10 sites (Brussels and 9 other locations) |
| Trial ID | NCT05911633 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of BioPearl™ microspheres loaded with Doxorubicin in patients with unresectable hepatocellular carcinoma (HCC). It is a prospective, single-arm, multi-center study involving 50 subjects who will be monitored until disease progression or the initiation of the next treatment. Participants will be followed for up to 18 months, with an intermediate analysis conducted to assess safety and technical success. The study seeks to provide insights into the potential benefits of this treatment approach for patients with HCC.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed unresectable HCC and specific tumor characteristics.
Not a fit: Patients with curable HCC or those with significant liver dysfunction may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with unresectable hepatocellular carcinoma.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific application of BioPearl™ microspheres is being further evaluated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brussels and 9 other locations
- CUB Hôpital Erasme — Brussels, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- Beaujon Hospital — Clichy, France (Recruiting)
- CHU Grenobles (Hôpital Michallon) — La Tronche, France (Not_yet_recruiting)
- Paul-Brousse Hospital — Villejuif, France (Recruiting)
- SLK-Kliniken Heilbronn — Heilbronn, Germany (Recruiting)
- University Hospital Tübingen — Tübingen, Germany (Recruiting)
- Fondazione IRCCS Instituto Tumori — Milan, Italy (Recruiting)
- Fondazione Policlinico Universitario A. Gemelli — Rome, Italy (Recruiting)
- Città della Salute e della Scienza di Torino — Turin, Italy (Recruiting)
Study contacts
- Study coordinator: Tamara Sals
- Email: tamara.sals@terumo-europe.com
- Phone: +32 483 53 41 06
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.