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New treatment option for Hepatocellular Carcinoma Non-resectable
Official title BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
ClinicalTrials.gov ID: NCT05911633
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject is at least 18 years old
- Subject with HCC confirmed by histology or according to the latest applicable version of EASL (the European Association for the Study of the Liver)...
- 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...
- 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...
- Subject with treatment failure/recurrence after a prior resection/ablation is permitted, with the exception of recurrence in the segment of a prior...
You likely can't join if
- Subject previously treated with any systemic therapy for HCC
- Subject previously treated with intra-arterial loco-regional therapy for HCC
- Eligible for curative treatment at the time of study inclusion
- Recurrence in the segment of a prior thermal ablation
- Advanced liver disease: Child-Pugh's B-C class or active gastrointestinal bleeding, encephalopathy
- Advanced tumoral disease: BCLC class C or D (vascular invasion - even segmental, extra-hepatic spread or cancer-related symptoms performance status...
See the full eligibility criteria
- Subject is at least 18 years old
- 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
- 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
- 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
- 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
- WHO (World Health Organization) or ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1
- Subject deemed treatable in one session for initial treatment
- Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh Class A)
- Total bilirubin ≤ 2.0 mg/dl
- Adequate bone marrow function: Hemoglobin ≥ 9g/dl, absolute neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 75 x 109/L
- Subject with no ascites or with minor ascites controlled by sodium dietary restrictions (subject receiving diuretic treatment or paracentesis is not eligible)
- Adequate renal function: serum creatinine \< 1.5 X ULN (Upper Limit of Normal)
- Subject has provided written informed consent
- people of childbearing/reproductive potential should use adequate birth control measures, during the study treatment period until survival follow-up
- Subject previously treated with any systemic therapy for HCC
- Subject previously treated with intra-arterial loco-regional therapy for HCC
- Eligible for curative treatment at the time of study inclusion
- Recurrence in the segment of a prior thermal ablation
- Advanced liver disease: Child-Pugh's B-C class or active gastrointestinal bleeding, encephalopathy
- Advanced tumoral disease: BCLC class C or D (vascular invasion - even segmental, extra-hepatic spread or cancer-related symptoms performance status \>1)
- 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...
- Subject with history of biliary tree disease or biliary dilatation
- Portal vein thrombosis, porto-systemic shunt, hepatofugal blood flow or absent portal blood flow in the liver area to be treated
- Contraindication to multiphasic CT and MRI (e.g. allergy to contrast media)
- Any other contraindication for embolization procedure or Doxorubicin treatment
- 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...
- 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...
- Pregnant or breast-feeding woman
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Leuven, Belgium
- Clichy, France
- La Tronche, France
- Villejuif, France
- Heilbronn, Germany
- Tübingen, Germany
- Milan, Italy
- Rome, Italy
- Turin, Italy
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Leuven, Belgium; Clichy, France; La Tronche, France; Villejuif, France; Heilbronn, Germany and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.