HepaSphere Chemoembolization in Advanced HCC Patients: Safety & Efficacy Registry in China (SUPER-China)

September 19, 2018 updated by: Hong Shan, Fifth Affiliated Hospital, Sun Yat-Sen University

Superselective Drug-Eluting Chemoembolization With HepaSphere in Unresectable Advanced HCC Patients: Safety & Efficacy Registry in China (SUPER-China)

The purpose of this multicenter registry is to gather the safety, efficacy and survival data in advanced HCC patients treated with HepaSphere in China in order to evaluate the application of HepaSphere deTACE in treating advanced HCC patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mingsheng Huang, MD
  • Phone Number: +86 020 85252066

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Ning Yang, MD
      • Beijing, China
        • Active, not recruiting
        • Cancer Hospital Chinese Academy of Medical Science
      • Guangzhou, China
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
          • Xiaofeng He, MD
      • Guangzhou, China
        • Recruiting
        • Fifth Affiliated Hospiatl, Sun Yet-Sen University
        • Contact:
          • Hong Shan, MD
        • Contact:
          • Long Fei Peng, MD
      • Guangzhou, China
        • Recruiting
        • Third Affiliated Hospiatl, Sun Yet-Sen Hospital
        • Contact:
          • Mingsheng Huang, MD
        • Contact:
      • Shanghai, China
        • Active, not recruiting
        • Zhongshan Hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with Advanced Hepatocellular Carcinoma (HCC)

Description

Inclusion Criteria:

  1. Age 18 or older
  2. Patient has signed informed consent

  3. Patient must have a diagnosis of hepatocellular cancer by at least one of the following method:

    1. Histological confirmation

    2. Classic imaging characteristics of HCC: Early enhancement (Arterial hypervascularity) and Venous or Delayed phase washout in multidetector contrast enhanced computed tomography (CT) scan / dynamic contrast-enhanced magnetic resonance imaging (MRI) imaging.

      • Either CT/ MRI shows at least one solid liver lesion ≥ 2 cm with the above described imaging characteristics of HCC.
      • In case of liver lesion between 1 and 2 cm, both CT and MRI imaging have to be performed in order to confirm the imaging characteristics of HCC.

  4. At time of study entry.

    1. Patients not suitable for ablation due to lesion location may be enrolled
    2. Patients with HCC recurrence but not suitable for resection or ablation maybe enrolled

  5. Patient MUST be with BCLC stage C and meet the following criteria:

    • Stage Child-Pugh A or B AND
    • Performance status ECOG ≤ 2 WITH Vascular Invasion or WITHOUT Vascular invasion
  6. Patient has a life expectancy of at least 6 months

Exclusion Criteria:

  1. Current or previous treatment with chemo- or radiation therapy or sorafenib
  2. Previous treatment of transarterial chemoembolization (TACE)
  3. Patients with current or history of any other cancer except non-melanomatous skin cancer
  4. Female patients who are pregnant, breastfeeding, or premenopausal and not using an effective method of contraceptive
  5. Performance status ECOG > 2
  6. Child-Pugh Class C
  7. Occlusive tumor thrombus to the main portal trunk
  8. Active gastrointestinal bleeding
  9. Evidence of uncorrectable bleeding diathesis
  10. Extra-Hepatic spread of the HCC
  11. >50% tumor involvement of the liver
  12. Infiltrative HCC
  13. Encephalopathy not adequately controlled medically
  14. Presence of ascites not controlled medically
  15. Any contraindication for MRI/ CT (eg. metallic implants)
  16. Allergy to contrast media that cannot be managed with prophylaxis
  17. Any contraindication to arteriography
  18. Any contraindication for doxorubicin administration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Device: HepaSphere Microspheres
HepaSphere Microsphere
Device: HepaSphere with 50-75mg Doxorubicin
HepaSphere with 50-75mg Doxorubicin
Other Names:
  • Superaborbent Polymer Microsphere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: 2- years
2- years
Progress-free-survival (PFS)
Time Frame: 2-years
2-years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 2-years
2-years
Objective Response Rates
Time Frame: 6-months
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fifth Affiliated Hospital, Sun Yat-Sen University

Collaborators

Third Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Principal Investigator: Hong Shan, MD, Fifth Affiliated Hospiatl, Sun Yet-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

April 15, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (ESTIMATE)

April 19, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 20, 2018

Last Update Submitted That Met QC Criteria

September 19, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEPA-China-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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