BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)

Launched by TERUMO EUROPE N.V. · Jun 20, 2023

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ClinConnect Summary

This clinical trial is studying a new treatment for patients with unresectable hepatocellular carcinoma (HCC), which is a type of liver cancer that cannot be surgically removed. The treatment being tested involves tiny particles called BioPearl™ microspheres that are loaded with a chemotherapy drug called Doxorubicin. The main goal of the trial is to confirm that this treatment is safe and successful in delivering the medication directly to the tumor. Additionally, researchers want to see how effective it is in shrinking or controlling the cancer.

To participate in this study, individuals must be at least 18 years old and have been diagnosed with HCC that meets certain criteria, such as having tumors smaller than 5 cm. Participants should also have liver function that is not severely impaired and must consent to the treatment. Throughout the trial, participants will receive the BioPearl™ treatment and will be monitored for their health and any side effects. This study is currently recruiting patients, and it is open to both men and women. If you or a loved one are considering participation, it's important to discuss this option with your healthcare provider to see if it might be appropriate for you.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is at least 18 years old
• • 2. Subject with HCC confirmed by histology or according to the latest applicable version of EASL (the European Association for the Study of the Liver) criteria
• • 3. Subject with tumor(s) \< 5 cm and within the up-to-7 criteria: the sum of the diameter of the largest tumor (in cm) and the number of tumors must be ≤ 7.0
• • 4. Subject with BCLC (Barcelona Clinic Liver Cancer) Stage A or B classification who is not a candidate for curative treatment at the time of study inclusion
• • 5. Subject with treatment failure/recurrence after a prior resection/ablation is permitted, with the exception of recurrence in the segment of a prior thermal ablation
• • 6. WHO (World Health Organization) or ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1
• • 7. Subject deemed treatable in one session for initial treatment
• • 8. Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh Class A)
• • 9. Total bilirubin ≤ 2.0 mg/dl
• • 10. Adequate bone marrow function: Hemoglobin ≥ 9g/dl, absolute neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 75 x 109/L
• • 11. Subject with no ascites or with minor ascites controlled by sodium dietary restrictions (subject receiving diuretic treatment or paracentesis is not eligible)
• • 12. Adequate renal function: serum creatinine \< 1.5 X ULN (Upper Limit of Normal)
• • 13. Subject has provided written informed consent
• • 14. Subjects of childbearing/reproductive potential should use adequate birth control measures, during the study treatment period until survival follow-up
• Exclusion Criteria:
• • 1. Subject previously treated with any systemic therapy for HCC
• • 2. Subject previously treated with intra-arterial loco-regional therapy for HCC
• • 3. Eligible for curative treatment at the time of study inclusion
• • 4. Recurrence in the segment of a prior thermal ablation
• • 5. Advanced liver disease: Child-Pugh's B-C class or active gastrointestinal bleeding, encephalopathy
• • 6. Advanced tumoral disease: BCLC class C or D (vascular invasion - even segmental, extra-hepatic spread or cancer-related symptoms performance status \>1)
• 7. History of another primary tumor. Exceptions include:
• • A. Malignancy treated with curative intent ≥ 5 years before inclusion and with no known active disease
• • B. Malignancy which occurred \< 5 years before, not active and not expected to recur or be clinically relevant in the next 5 years
• • 8. Subject with history of biliary tree disease or biliary dilatation
• • 9. Portal vein thrombosis, porto-systemic shunt, hepatofugal blood flow or absent portal blood flow in the liver area to be treated
• • 10. Contraindication to multiphasic CT and MRI (e.g. allergy to contrast media)
• • 11. Any other contraindication for embolization procedure or Doxorubicin treatment
• • 12. Subject 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
• • 13. In the Investigator's opinion subject has (a) co-morbid condition(s) that could limit the subject's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
• • 14. Pregnant or breast-feeding woman