BioPearl™ Microspheres Loaded With Doxorubicin: Prospective, Single Arm, Multi-centre Post-market Follow-up Study.
Megadott ok: Study cancelled by Sponsor decision
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Trial details
- Who runs it
- Terumo Europe N.V.
- Trial code
- NCT04231929
- Record updated
- 2022. március 28.
- Original description
The primary objective of the study is to confirm safety and efficacy of BioPearl™ microspheres loaded with doxorubicin in the treatment of patients with unresectable hepatocellular carcinoma (HCC).Read full original descriptionShow less
BioPearl™ Microspheres Loaded With Doxorubicin to Treat Patients With Unresectable HCC: Prospective, Single Arm, Multi-centre Post-market Follow-up Study.
The primary objective of the study is to confirm safety and efficacy of BioPearl™ microspheres loaded with doxorubicin in the treatment of patients with unresectable hepatocellular carcinoma (HCC).
Inclusion: Patient is at least 18 years old; Patient with HCC confirmed by histology or according to the latest applicable version of the EASL criteria; Patient with a single nodular tumor 6 cm or less in longest diameter or patient with no more than three tumor nodules, each 4 cm or less in longest diameter. Infiltrative disease is excluded; BCLC B patient or BCLC A patient not a candidate for curative treatment at the time of study inclusion or who has failed/recurred after resection/ablation; Patient 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; Patient with no ascites or with medically controlled ascites; Adequate renal function (serum creatinine < 1.5 X ULN); Patient has provided written informed consent.
Exclusion: Patient previously treated with any systemic therapy for HCC; Patient previously treated with a loco-regional therapy for HCC. Prior resection/ablation is allowed as per inclusion criteria 4; Patient 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; 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); Patient 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); In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study; Eligible for curative treatment at the time of study inclusion; Patient with another primary tumor; Any other contraindication for embolization procedure or doxorubicin treatment; Pregnant or breast-feeding women.