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

Not Applicable

Withdrawn

• Conditions: Hepatocellular Carcinoma
• Interventions: Device: Chemoembolization

• Registration Number: NCT04231929
• Lead Sponsor: Terumo Europe N.V.

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.

Study Timeline

• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Study Start: 2020-05
• Primary Completion: 2021-03
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-11
• Last Update Posted: 2022-03-28
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BioPearl™ loaded with doxorubicin	Chemoembolization	Chemoembolization with doxorubicin-loaded BioPearl™ microspheres

Primary Outcome Measures

Name	Time	Method
Incidence of grade 3-4-5 adverse events related with procedure or study device	4 weeks	Safety by monitoring and evaluating all grade 3-4-5 adverse events related with procedure or study device
Tumor response	12 weeks	Tumor response rate assessed by mRECIST criteria

Secondary Outcome Measures

Name	Time	Method
Technical success	1 day	Ability to reach stasis in the treated tumor feeding arteries during chemoembolization procedure
Time to progression of treated tumor(s)	3 years	Time from treatment to progression of the treated lesion according to mRECIST criteria
Time to un-TACEable progression	3 years	Time from treatment to un-TACEable progression of the treated lesion according to EASL criteria
Hepatic progression free survival	3 years	Time from treatment to progression anywhere in the liver according to mRECIST criteria or death from any cause
Progression free survival	3 years	Time from treatment to progression in the liver or outside the liver or death from any cause
Overall survival	3 years	Time from treatment until death from any cause
Best overall response	3 years	Best response of treated tumor(s) recorded during the course of the study according to mRECIST criteria

Trial Locations

Locations (3)

University Hospital Leuven; 🇧🇪 Leuven, Belgium

CUB Hôpital Erasme; 🇧🇪 Brussels, Belgium

UZ Gent; 🇧🇪 Gent, Belgium