Safety and Efficacy of Doxorubicin-eluting-bead Embolization in Patients With Advanced Hepatocellular Carcinoma

NCT02525380 | Unknown Phase 4 DMC

• 1 other identifier: DCbead_PVTT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Safety and efficacy of doxorubicin-eluting-bead embolization in patients with advanced hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Keywords

Transarterial chemoembolization; Doxorubicin-Eluting-Bead Embolization; DC Bead TACE; Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• The rate of Time to progression of hepatocellular carcinoma 30 patients.

  The rate of Time to progression of doxorubicin eluting bead embolization in patients with advanced hepatocellular carcinoma.After the treatment period, patients will undergo follow up for safety within 30 days (+7 days) of final DEBDOX, and will undergo follow up for survival every 84 days (±14 days) (84 days is the day counted from the DEBDOX TACE) for at least 3 years.

  up to at least 3 years

Study Arms (1)

Doxorubicin loadeing-DC Bead(Device)

EXPERIMENTAL

DC Bead comprises hydrogel microspheres that are biocompatible, hydrophilic, non resorbable, precisely calibrated and capable of loading doxorubicin. DC Bead is produced from polyvinyl alcohol.

Procedure: Device(DC Bead)

Interventions

Device(DC Bead) PROCEDURE

Doxorubicin-Eluting-Bead Embolization (DEBDOX), DC Bead are a novel drug delivery embolization system

Doxorubicin loadeing-DC Bead(Device)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent.
• Clinical or histological diagnosis of HCC based on the guidelines of the American Association for the Study of Liver Diseases.
• At least one typical enhanced lesion that is bi-dimensionally measurable by multiphasic spiral CT scan or dynamic contrast-enhanced MRI.
• Tumor conditions confirmed by abdominal imaging (contrast enhanced CT ± MRI) performed within 1 month prior to the enrollment:
• Age of at least 18 years and less than 80 years.
• ECOG Performance Status of 0 or 1.
• Child-Pugh class A or B (Child-Pugh score ≤ 7).
• Life expectancy of at least 16 weeks.
• Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements (no transfusion, no restoration), conducted within 14 days prior to screening:
• Hemoglobin ≥ 8.0 g/dL
• Absolute neutrophil count ≥ 1,000/mm3
• Platelet count ≥ 50,000/μL
• Total bilirubin \<2.5 mg/dL
• Serum albumin ≥2.8 g/dL
• ALT and AST \< 5 × upper limit of normal

You may not qualify if:

• A history of receiving any systemic therapy of the molecularly targeted agents, immunotherapy or cytotoxic chemotherapy for the treatment of HCC
• Invasion of inferior vena cava (Vv3), or invasion of first order branch of the biliary duct (B3)
• History or presence of hepatic encephalopathy
• Ascites, moderate, large or intractable
• Active clinically serious infections (\> grade 2, NCI-CTC version 4.0), including spontaneous bacterial peritonitis.
• Untreated active chronic hepatitis B
• Esophageal or gastric varices≥ F2 (grade 2) with red color sign positive without prophylaxis (non-selective beta-blocker or endoscopic variceal ligation) or history of variceal bleeding without endoscopic variceal ligation/ injection sclerosis
• Active ulcer of stomach or duodenum: untreated or presence of visible vessel
• Any major surgery within 4 weeks, or any minor surgery within 2 weeks prior to signing the informed consent form
• Candidate for liver transplant and a history of liver transplantation
• History of cardiac disease: congestive heart failure greater than NYHA class 2; active coronary artery disease; cardiac arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension and diabetes mellitus
• History of AIDS/HIV infection.
• Seizure disorder requiring medication.
• History of organ allograft.
• Evidence or history of bleeding diathesis, or thromboembolic events requiring treatment

Sponsors & Collaborators

• Seoul National University Hospital: lead
• BTG International Inc.: collaborator

Study Sites (1)

Seoul National University

Seoul, ASI|KR|KS013, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Yoon Jun Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: August 17, 2015
• Study Start: September 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: August 1, 2018
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

KR (1)