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

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).

Study Overview

• Status: Withdrawn
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Device: Chemoembolization

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • CUB Hôpital Erasme
  • Gent, Belgium, 9000
    • UZ Gent
  • Leuven, Belgium, 3000
    • University Hospital Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: BioPearl™ loaded with doxorubicin; Chemoembolization with doxorubicin-loaded BioPearl™ microspheres

Device: 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.; Other Names: TACE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Terumo Europe N.V.
• Investigators: Principal Investigator: Gontran Verset, MD, CUB Hôpital Erasme; Principal Investigator: Geert Maleux, MD, UZ Leuven; Principal Investigator: Luc Defreyne, MD, UZ Gent

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: HCC; Unresectable; TACE; Chemoembolization; BioPearl®
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular
• Other Study ID Numbers: T135E5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No