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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2010 by Tianjin Medical University Cancer Institute and Hospital
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01393197
First received: July 11, 2011
Last updated: July 31, 2014
Last verified: November 2010

July 11, 2011
July 31, 2014
March 2011
November 2014   (final data collection date for primary outcome measure)
Time to progression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Time to progression
Same as current
Complete list of historical versions of study NCT01393197 on ClinicalTrials.gov Archive Site
  • total survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    total survival
  • remission rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    remission rate
Same as current
Not Provided
Not Provided
 
Transcatheter Arterial Chemoembolization With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas (TACE-KMG)
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?

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Carcinoma, Hepatocellular
Other: Therapeutic Chemoembolization
Transcatheter Arterial Chemoembolization
Other Name: Transcatheter Arterial Chemoembolization,TACE
  • 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
    Intervention: Other: Therapeutic Chemoembolization
  • Experimental: TACE-KMG ( routine dose Chemo)
    embolization agent:KMG microsphere( 150-450µm,0.2-2g) with routine dose Epirubicin (30-40mg/m2)
    Intervention: Other: Therapeutic Chemoembolization
  • Experimental: TACE-KMG( low dose Chemo )
    embolization agent:KMG microsphere( 150-450µm,0.2-2g) with low dose Epirubicin (5-10mg/m2)
    Intervention: Other: Therapeutic Chemoembolization
  • Experimental: TACE-KMG(without chemo)
    embolization agent:KMG microsphere( 150-450µm,0.2-2g)
    Intervention: Other: Therapeutic Chemoembolization
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2480
December 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Zhi Guo, MD 13920076145 cjr.guozhi@vip.163.com
Contact: Haipeng Yu, MD 13352070835 jieruke@yahoo.com.cn
China
 
NCT01393197
TMU-CIH-IR-003
No
Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Cancer Institute and Hospital
Not Provided
Study Chair: Zhi Guo, MD Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Cancer Institute and Hospital
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP