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

NCT ID: NCT04231929

Last Updated: 2022-03-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-31
• Study Completion Date: 2023-12-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

BioPearl™ loaded with doxorubicin

Chemoembolization with doxorubicin-loaded BioPearl™ microspheres

Group Type: EXPERIMENTAL

Chemoembolization

Intervention Type: DEVICE

First, an angiography of the celiac trunk, superior mesenteric artery and hepatic artery will be obtained by using a peripheral arterial approach.

Arterial embolization will be performed through catheterization of intrahepatic arteries, as selectively as possible (tumor feeders, subsegmental, segmental). The size of the microcatheter must be consistent with the size of BioPearl™ microspheres used. Microspheres of 200 µm will be be used. They will be loaded with the appropriate dose of doxorubicin injectable solution, mixed with the contrast media and distributed according to the location of the HCC lesions. The endpoint of the procedure will be achieved end when stasis of the feeders is achieved.

Interventions

Chemoembolization

First, an angiography of the celiac trunk, superior mesenteric artery and hepatic artery will be obtained by using a peripheral arterial approach.

Arterial embolization will be performed through catheterization of intrahepatic arteries, as selectively as possible (tumor feeders, subsegmental, segmental). The size of the microcatheter must be consistent with the size of BioPearl™ microspheres used. Microspheres of 200 µm will be be used. They will be loaded with the appropriate dose of doxorubicin injectable solution, mixed with the contrast media and distributed according to the location of the HCC lesions. The endpoint of the procedure will be achieved end when stasis of the feeders is achieved.

Intervention Type: DEVICE

Other Intervention Names

TACE

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.

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.

Exclusion Criteria

1. Patient previously treated with any systemic therapy for HCC.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Terumo Europe N.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gontran Verset, MD

Role: PRINCIPAL_INVESTIGATOR

CUB Hôpital Erasme

Geert Maleux, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Luc Defreyne, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Gent

Locations

CUB Hôpital Erasme

Brussels, , Belgium

UZ Gent

Ghent, , Belgium

University Hospital Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

T135E5

Identifier Type: -

Identifier Source: org_study_id