Transcatheter Arterial Chemoembolization With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas (TACE-KMG) (TACE-KMG)

December 17, 2015 updated by: Tianjin Medical University Cancer Institute and Hospital

Clinical Trial of Transcatheter Arterial Chemoembolization (TACE)With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas

The purpose of this study is to evaluate the effects of Transcatheter Arterial Chemoembolization (TACE) with KMG microsphere in treating HCC. And to determine which one is better,KMG microsphere or lipiodol?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The most important part of effect in TACE is embolization .But there is no clinical trials on which one is better,KMG microsphere or lipiodol? what effect did chemo play in the TACE treating HCC? Which one is better,routine dose or low dose? Experts in USA and Japan had their own researches and standpoints.We think it is important to push a clinical trail to answer these problem.

Study Type

Interventional

Enrollment (Anticipated)

2480

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hepatocellular Carinomas with diagnosis of pathology or cytology or consistent with China 2001 guideline of Clinical Diagnosis Hepatocellular Carinomas clinical stage（The Barcelona Liver Clinic staging system,BCLC B and C)，or can not receive surgical intervention
  • liver function:Child-Pugh A、B
  • PST 0-1（Eastern Cooperative Oncology Group Performance Score ,ECOG）
  • Lifespan≥6 months
  • First time to receive treatment
  • Can accept the follow up
  • informed consent was gotten
  • the number of lesion ≤ 5

Exclusion Criteria:

  • pregnant or lactation woman
  • emotional disturbance
  • serious heart ,lung disfunction or serious diabetes mellitus
  • serious reactiveness infections;（exp:type B or C hepatitis）
  • liver function :Child-Pugh Score C
  • thrombocyte<6×109/L
  • diffuse HCC
  • widespread metastasis
  • serious atherosclerosis
  • acquired immunodeficiency syndrome;AIDS
  • thrombosis or thrombosis event in 6 months
  • renal inadequacy who need hemodialysis or peritoneal dialysis
  • with other tumors except basal cell carcinoma and carcinoma in situ of cervix
  • serious alimentary tract hemorrhage in 4 weeks

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TACE -oil
embolization agent:Iodinated Oil or /and gelatin sponge Iodinated Oil （5-30ml）with Epirubicin （30-40mg/m2） or and gelatin sponge
Other: Therapeutic Chemoembolization
Transcatheter Arterial Chemoembolization
Other Names:
  • Transcatheter Arterial Chemoembolization，TACE
Experimental: TACE-KMG ( routine dose Chemo)
embolization agent:KMG microsphere( 150-450µm,0.2-2g) with routine dose Epirubicin （30-40mg/m2）
Other: Therapeutic Chemoembolization
Transcatheter Arterial Chemoembolization
Other Names:
  • Transcatheter Arterial Chemoembolization，TACE
Experimental: TACE-KMG( low dose Chemo )
embolization agent:KMG microsphere( 150-450µm,0.2-2g) with low dose Epirubicin （5-10mg/m2）
Other: Therapeutic Chemoembolization
Transcatheter Arterial Chemoembolization
Other Names:
  • Transcatheter Arterial Chemoembolization，TACE
Experimental: TACE-KMG(without chemo)
embolization agent:KMG microsphere( 150-450µm,0.2-2g)
Other: Therapeutic Chemoembolization
Transcatheter Arterial Chemoembolization
Other Names:
  • Transcatheter Arterial Chemoembolization，TACE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression
Time Frame: 3 years
Time to progression
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total survival
Time Frame: 3 years
total survival
3 years
remission rate
Time Frame: 3 years
remission rate
3 years

Collaborators and Investigators

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

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Investigators

  • Study Chair: Zhi Guo, MD, Tianjin Medical University Cancer Institute and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

March 1, 2011

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

July 11, 2011

First Submitted That Met QC Criteria

July 12, 2011

First Posted (Estimate)

July 13, 2011

Study Record Updates

Last Update Posted (Estimate)

December 18, 2015

Last Update Submitted That Met QC Criteria

December 17, 2015

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMU-CIH-IR-003

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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