Study in the Treatment of HCC With a Radiopaque (RO) Bead (LC Bead LUMI™) Loaded With Doxorubicin

NCT03452553 | Withdrawn FDA Device

• 1 other identifier: BTG004387-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer. This type of cancer may be "hypervascular". Hypervascular means there is an increased number or concentration of blood vessels. These blood vessels get their blood supply from the hepatic artery, while the non-tumor liver tissue gets blood supply from the portal vein. Therefore, blockage of the hepatic artery to cut off the blood supply to the tumor is possible without affecting the normal liver. This research protocol will study chemoembolization using radiopaque beads loaded with a chemotherapy drug called doxorubicin. Chemoembolization is a procedure in which the blood supply to a tumor is blocked after anticancer drugs are given in blood vessels near the tumor. In this study, the anticancer drug, doxorubicin, is attached to small beads that are injected into an artery that feeds the tumor. The radiopaque beads (RO beads) are visible on imagining scans (X-rays) so that the Interventional Radiologist performing the chemoembolization procedure can see the location of the beads in the tumor during and after the procedure. The visibility of the beads allows the interventional radiologist to confirm where the beads loaded with doxorubicin have been delivered in the tumor; this in theory could help to improve the efficiency of embolization and plan the next course of treatment. In addition to the embolization, the beads elute a sustained dose of doxorubicin locally to the tumor site as a second effect.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

Liver Cancer; Hepatocellular Carcinoma (HCC); Trans Arterial Chemo Embolization (TACE); Drug Eluting Beads (DEB); Doxorubicin (DOX)

Outcome Measures

Primary Outcomes (1)

• Efficacy: Time to progression (TTP)

  Time when progression is first observed at a tumor assessment according to mRECIST evaluated by CT scan or MRI.

  12 months

Secondary Outcomes (5)

• Safety: Adverse Events (AE) and Serious Adverse Events (SAE)

  Assessed at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months post first treatment

• Objective Response Rate (ORR) and Disease Control Rate (DCR)

  Assessed at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months post first treatment

• Time to local progression (TTLP)

  Assessed at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months post first treatment

• Overall survival (OS)

  Assessed at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months

• Physician rating of the handling and visibility of LC Bead LUMI™.

  Intra and post intervention at Day 1, and 6 and 12 months post first treatment.

Study Arms (1)

Open Label Treatment

EXPERIMENTAL

Chemoembolization using LC Bead LUMI™ (Radiopaque (RO) Bead) loaded with doxorubicin

Device: LC Bead LUMI™ (Radiopaque (RO) Bead) loaded with doxorubicin

Interventions

LC Bead LUMI™ (Radiopaque (RO) Bead) loaded with doxorubicin DEVICE

Drug Eluting Beads loaded with chemotherapy

Open Label Treatment

Eligibility Criteria

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

You may qualify if:

• Patient with HCC, diagnosed by at least one of the following:
• Imaging according to the American Association for the Study of Liver Disease (AASLD) guidelines
• Histology
• Adults (18 years of age or older)
• Tumor not suitable for resection, ablation or transplantation at the time of study entry
• Patient is a candidate for TACE after multidisciplinary team (MDT) decision
• HCC Barcelona Clinic Liver Cancer (BCLC) B or BCLC A not eligible for or refuses curative treatment, or BCLC C (Performance Status 1 only)
• At least one measurable disease according to mRECIST
• Preserved liver function (Child Pugh Score A and B7)
• Performance Status: Eastern Cooperative Oncology Group score of 0 or 1 or Karnofsky Performance Status 80 -100 at study entry
• TACE of all lesions can be achieved within a single cycle (2 sessions in 21 days +/- 7 days for the first cycle only)
• Life expectancy of at least 6 months at study entry
• Women and men of child bearing potential must agree to use adequate contraception prior, during and post therapy according to the standard instructions at the study site
• Negative serum or urine pregnancy test at study entry for woman of childbearing potential according to institutional policy
• Patient is willing and able to provide written signed and dated informed consent

You may not qualify if:

• Extrahepatic metastases
• Portal vein tumor thrombosis (any type I to IV, refer to appendix 12.6)
• Patient on waiting list for transplantation
• Hematology:
• Hemoglobin \<9g/dL, or
• White Blood Cell (WBC) \<2,500 cells/mm3, or
• Absolute Neutrophil Count (ANC) \<1,500 cells/mm3, or
• Platelets \<50,000/mm3, or
• International Normalized Ratio (INR) \> 1.8
• Renal
• Glomerular Filtration Rate (GFR) \<30 mL/min/1.73m2
• Creatinine \>2 mg/dL
• Hepatic
• Any single tumor nodule \> 7cm (Multiple lesions can be included but not one \>7cm)
• Estimated tumor burden \>50%

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• Biocompatabilities UK Ltd: collaborator

Related Publications (16)

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• European Association for Study of Liver; European Organisation for Research and Treatment of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. Eur J Cancer. 2012 Mar;48(5):599-641. doi: 10.1016/j.ejca.2011.12.021. No abstract available.

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  PMID: 22009576 BACKGROUND

• Levy EB, Krishnasamy VP, Lewis AL, Willis S, Macfarlane C, Anderson V, van der Bom IM, Radaelli A, Dreher MR, Sharma KV, Negussie A, Mikhail AS, Geschwind JF, Wood BJ. First Human Experience with Directly Image-able Iodinated Embolization Microbeads. Cardiovasc Intervent Radiol. 2016 Aug;39(8):1177-86. doi: 10.1007/s00270-016-1364-8. Epub 2016 May 20.

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Related Links

• Sponsor Website

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: Open Label

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: March 2, 2018
• Study Start: July 1, 2018
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share