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

NCT04231929 | Withdrawn DMC

• 1 other identifier: T135E5
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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).

Conditions

Hepatocellular Carcinoma

Keywords

HCC; Unresectable; BioPearl®; TACE; Chemoembolization

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Technical success

  1 day

• Time to progression of treated tumor(s)

  3 years

• Time to un-TACEable progression

  3 years

• Hepatic progression free survival

  3 years

• Progression free survival

  3 years

Study Arms (1)

BioPearl™ loaded with doxorubicin

EXPERIMENTAL

Chemoembolization with doxorubicin-loaded BioPearl™ microspheres

Device: Chemoembolization

Interventions

Chemoembolization 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.

Also known as: TACE

BioPearl™ loaded with doxorubicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Terumo Europe N.V.: lead

Study Sites (3)

CUB Hôpital Erasme

Brussels, 1070, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

University Hospital Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Chemoembolization, Therapeutic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Embolization, Therapeutic; Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Study Officials

• Gontran Verset, MD

  CUB Hôpital Erasme

  PRINCIPAL INVESTIGATOR

• Geert Maleux, MD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

• Luc Defreyne, MD

  UZ Gent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: May 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: December 1, 2023
• Last Updated: March 28, 2022

Record last verified: 2022-03

Locations

BE (3)