BioPearl™ Microspheres Loaded With Doxorubicin: Prospective, Single Arm, Multi-centre Post-market Follow-up Study. (BIOPEARL-FIRST)

Terumo

Status

Withdrawn

Conditions

Hepatocellular Carcinoma

Treatments

Device: Chemoembolization

Study type

Interventional

Funder types

Industry

Identifiers

NCT04231929

T135E5

Details and patient eligibility

About

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).

Full description

This is a prospective, single arm, multi-centre, post-market study to further assess safety and efficacy in 20 unresectable HCC patients treated with Doxorubicin loaded BioPearl™ microspheres.

After the treatment procedure, all patients will undergo clinical follow-up until disease progression and/or next treatment option after which patients will be followed for survival. Patients will be followed up to a maximum of 3 years.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.
Eligible for curative treatment at the time of study inclusion.
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 another primary tumor.
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).
Any other contraindication for embolization procedure or doxorubicin treatment.
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.
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.
Pregnant or breast-feeding women.