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
  Purpose

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?


Condition Intervention
Carcinoma, Hepatocellular
Other: Therapeutic Chemoembolization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial of Transcatheter Arterial Chemoembolization (TACE)With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • Time to progression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Time to progression


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 2480
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Transcatheter Arterial Chemoembolization,TACE

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393197

Contacts
Contact: Zhi Guo, MD 13920076145 cjr.guozhi@vip.163.com
Contact: Haipeng Yu, MD 13352070835 jieruke@yahoo.com.cn

Locations
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Zhi Guo, MD    13920076145    cjr.guozhi@vip.163.com   
Contact: Haipeng Yu, MD    13352070835    jieruke@yahoo.com.cn   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
Study Chair: Zhi Guo, MD Tianjin Medical University Cancer Institute and Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01393197     History of Changes
Other Study ID Numbers: TMU-CIH-IR-003
Study First Received: July 11, 2011
Last Updated: July 31, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
HCC
TACE

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on August 21, 2014