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Completed

NCT Number: NCT03564405

Pilot Clinical Trial to Evaluate the UNI-DEB for Unresectable Hepatocellular Carcinoma

Pilot Clinical Trial to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma

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Key information

Conditions

Hepatocellular Carcinoma Non-resectable

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University Seoul St. Mary Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 19 years
  • Diagnosis of HCC
  • Unresectable asymtomatic uninodular or multinodular tumor.
  • Subject who maintain clinically normal hepatopetal flow without main portal vein closure
  • At least one measurable target lesion by CT or MRI which 10 mm or more.
  • ECOG Performance Status of 0 or 1.
  • Child-Pugh class A or B
  • Life expectancy of at least 6 months.

Exclusion criteria

  • Another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia
  • Hepatic resection, liver transplantation or Percutaneous local treatment
  • Previously received HCC related medical procedure
  • Previously treated with anthracyclines
  • Only measurable disease is within an area of the liver previously subjected to radiotherapy.
  • Child Pugh C
  • Active gastrointestinal bleeding within 6 months from screening.
  • Total bilirubin > 3mg/dL
  • WBC < 3,000cells/mm3
  • ANC < 1,500cells/mm3
  • Platelet < 50,000mm3
  • Serum creatinine > 2mg/dL
  • INR > 1.4
  • ALT and AST > 5 times UNL
  • Diffuse HCC defined as >50% tumor involvement of the whole liver.

Treatment and study plan

UNI-DEB

Device

Applicate the TACE with UNI-DEB to unresectable hepatocellular carcinoma patient

Primary outcomes

  1. Objective Response Rate

    Time frame: 4 weeks after treatment

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Open, Single-arm, Uncontrolled, Single Center, Pilot Study to Evaluate the Efficacy and Safety of UNI-DEB for Unresectable Hepatocellular Carcinoma

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 20, 2018
Registry last updated
Jun 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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