Actively Recruiting
BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
Led by Terumo Europe N.V. · Updated on 2025-01-22
50
Participants Needed
10
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is at least 18 years old
- Diagnosed with hepatocellular carcinoma confirmed by histology or EASL criteria
- Tumors smaller than 5 cm and meet the up-to-7 criteria (largest tumor diameter plus number of tumors 64 7)
- BCLC Stage A or B and not eligible for curative treatment at study inclusion
- Prior resection or ablation allowed if not recurring in prior thermal ablation segment
- WHO or ECOG performance status 0 or 1
- Treatable in one session for initial treatment
- Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh Class A)
- Total bilirubin 64 2.0 mg/dl
- Adequate bone marrow function (Hemoglobin 65 9 g/dl, neutrophils 65 1.0 x 10^9/L, platelets 65 75 x 10^9/L)
- No ascites or minor ascites controlled by sodium restriction (no diuretics or paracentesis)
- Adequate renal function (serum creatinine < 1.5 x ULN)
- Provided written informed consent
- Use adequate birth control if of childbearing potential during treatment until survival follow-up
You will not qualify if you...
- Previous systemic therapy for HCC
- Previous intra-arterial loco-regional therapy for HCC
- Eligible for curative treatment at study inclusion
- Recurrence in segment of prior thermal ablation
- Advanced liver disease (Child-Pugh B-C, active GI bleeding, encephalopathy)
- Advanced tumor stage (BCLC C or D, vascular invasion, extra-hepatic spread, performance status >1)
- History of other primary tumors unless cured >5 years ago or not active/expected to recur
- History of biliary tree disease or biliary dilation
- Portal vein thrombosis, porto-systemic shunt, hepatofugal or absent portal blood flow in treated liver area
- Contraindication to multiphasic CT or MRI
- Any other contraindications to embolization or Doxorubicin
- Current participation in investigational drug/device study interfering with endpoints
- Co-morbid conditions limiting participation or compliance
- Pregnant or breastfeeding woman
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
CUB Hôpital Erasme
Brussels, Belgium
Actively Recruiting
2
UZ Leuven
Leuven, Belgium
Actively Recruiting
3
Beaujon Hospital
Clichy, France
Actively Recruiting
4
CHU Grenobles (Hôpital Michallon)
La Tronche, France
Not Yet Recruiting
5
Paul-Brousse Hospital
Villejuif, France
Actively Recruiting
6
SLK-Kliniken Heilbronn
Heilbronn, Germany
Actively Recruiting
7
University Hospital Tübingen
Tübingen, Germany
Actively Recruiting
8
Fondazione IRCCS Instituto Tumori
Milan, Italy
Actively Recruiting
9
Fondazione Policlinico Universitario A. Gemelli
Rome, Italy
Actively Recruiting
10
Città della Salute e della Scienza di Torino
Turin, Italy
Actively Recruiting
Research Team
T
Tamara Sals
CONTACT
F
Florence Chow
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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