Clinical trial NCT04231929: BioPearl™ Microspheres Loaded With Doxorubicin: Prospective, Single Arm, Multi-centre Post-market Follow-up Study.
Official title: BioPearl™ Microspheres Loaded With Doxorubicin to Treat Patients With Unresectable HCC: Prospective, Single Arm, Multi-centre Post-market Follow-up Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: HCC
Unresectable
BioPearl®
TACE
Chemoembolization
Lead sponsor: Terumo Europe N.V.
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Patient is at least 18 years old.
2. Patient with HCC confirmed by histology or according to the latest applicable version of the EASL criteria.
3. 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.
4. 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.
5. Patient deemed treatable in one session for initial treatment.
6. Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh Class A).
7. Total bilirubin ≤ 2.0 mg/dl.
8. Patient with no ascites or with medically controlled ascites.
9. Adequate renal function (serum creatinine \< 1.5 X ULN).
10. Patient has provided written informed consent.

Exclusion Criteria:

1. Patient previously treated with any systemic therapy for HCC.
2. Patient previously treated with a loco-regional therapy for HCC. Prior resection/ablation is allowed as per inclusion criteria 4.
3. Eligible for curative treatment at the time of study inclusion.
4. Advanced liver disease: Child-Pugh's B-C class or active gastrointestinal bleeding, encephalopathy.
5. Advanced tumoral disease: BCLC class C or D (vascular invasion - even segmental, extra-hepatic spread or cancer-related symptoms performance status ≥1).
6. Patient with another primary tumor.
7. Patient with history of biliary tree disease or biliary dilatation.
8. Portal vein thrombosis, porto-systemic shunt, hepatofugal blood flow or absent portal blood flow in the liver area to be treated.
9. Contraindication to multiphasic CT and MRI (e.g. allergy to contrast media).
10. Any other contraindication for embolization procedure or doxorubicin treatment.
11. 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.
12. 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.
13. Pregnant or breast-feeding women.

Primary outcomes:
measure: Incidence of grade 3-4-5 adverse events related with procedure or study device
timeFrame: 4 weeks
measure: Tumor response
timeFrame: 4 weeks
measure: Tumor response
timeFrame: 12 weeks
Secondary outcomes:
measure: Technical success
timeFrame: 1 day
measure: Time to progression of treated tumor(s)
timeFrame: 3 years
measure: Time to un-TACEable progression
timeFrame: 3 years
measure: Hepatic progression free survival
timeFrame: 3 years
measure: Progression free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
measure: Best overall response
timeFrame: 3 years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CUB Hôpital Erasme
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: University Hospital Leuven
Study officials:
affiliation: CUB Hôpital Erasme
name: Gontran Verset, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Leuven
name: Geert Maleux, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Gent
name: Luc Defreyne, MD
role: PRINCIPAL_INVESTIGATOR
References: