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

Hepatocellular Carcinoma Clinical Trial

— BIOPEARL-FIRST  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04231929
• Other study ID #: T135E5
• Status: Withdrawn
• Phase: N/A
• Start date: May 2020
• Est. completion date: December 2023

Study information

• Verified date: March 2022
• Source: Terumo Europe N.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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.

Locations

Country	Name	City	State
Belgium	CUB Hôpital Erasme	Brussels
Belgium	UZ Gent	Gent
Belgium	University Hospital Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Terumo Europe N.V.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Tumor response	Tumor response rate assessed by mRECIST criteria	4 weeks
Primary	Tumor response	Tumor response rate assessed by mRECIST criteria	12 weeks
Secondary	Technical success	Ability to reach stasis in the treated tumor feeding arteries during chemoembolization procedure	1 day
Secondary	Time to progression of treated tumor(s)	Time from treatment to progression of the treated lesion according to mRECIST criteria	3 years
Secondary	Time to un-TACEable progression	Time from treatment to un-TACEable progression of the treated lesion according to EASL criteria	3 years
Secondary	Hepatic progression free survival	Time from treatment to progression anywhere in the liver according to mRECIST criteria or death from any cause	3 years
Secondary	Progression free survival	Time from treatment to progression in the liver or outside the liver or death from any cause	3 years
Secondary	Overall survival	Time from treatment until death from any cause	3 years
Secondary	Best overall response	Best response of treated tumor(s) recorded during the course of the study according to mRECIST criteria	3 years