search
Back to results

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

Primary Purpose

Carcinoma, Hepatocellular

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Therapeutic Chemoembolization
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring HCC, TACE

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

TACE -oil

TACE-KMG ( routine dose Chemo)

TACE-KMG( low dose Chemo )

TACE-KMG(without chemo)

Arm Description

embolization agent:Iodinated Oil or /and gelatin sponge Iodinated Oil （5-30ml）with Epirubicin （30-40mg/m2） or and gelatin sponge

embolization agent:KMG microsphere( 150-450µm,0.2-2g) with routine dose Epirubicin （30-40mg/m2）

embolization agent:KMG microsphere( 150-450µm,0.2-2g) with low dose Epirubicin （5-10mg/m2）

embolization agent:KMG microsphere( 150-450µm,0.2-2g)

Outcomes

Primary Outcome Measures

Time to progression
Time to progression

Secondary Outcome Measures

total survival
total survival
remission rate
remission rate

Full Information

First Posted
July 11, 2011
Last Updated
December 17, 2015
Sponsor
Tianjin Medical University Cancer Institute and Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01393197
Brief Title
Transcatheter Arterial Chemoembolization With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas (TACE-KMG)
Acronym
TACE-KMG
Official Title
Clinical Trial of Transcatheter Arterial Chemoembolization (TACE)With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
HCC, TACE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TACE -oil
Arm Type
Active Comparator
Arm Description
embolization agent:Iodinated Oil or /and gelatin sponge Iodinated Oil （5-30ml）with Epirubicin （30-40mg/m2） or and gelatin sponge
Arm Title
TACE-KMG ( routine dose Chemo)
Arm Type
Experimental
Arm Description
embolization agent:KMG microsphere( 150-450µm,0.2-2g) with routine dose Epirubicin （30-40mg/m2）
Arm Title
TACE-KMG( low dose Chemo )
Arm Type
Experimental
Arm Description
embolization agent:KMG microsphere( 150-450µm,0.2-2g) with low dose Epirubicin （5-10mg/m2）
Arm Title
TACE-KMG(without chemo)
Arm Type
Experimental
Arm Description
embolization agent:KMG microsphere( 150-450µm,0.2-2g)
Intervention Type
Other
Intervention Name(s)
Therapeutic Chemoembolization
Other Intervention Name(s)
Transcatheter Arterial Chemoembolization，TACE
Intervention Description
Transcatheter Arterial Chemoembolization
Primary Outcome Measure Information:
Title
Time to progression
Description
Time to progression
Time Frame
3 years
Secondary Outcome Measure Information:
Title
total survival
Description
total survival
Time Frame
3 years
Title
remission rate
Description
remission rate
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi Guo, MD
Phone
13920076145
Email
cjr.guozhi@vip.163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haipeng Yu, MD
Phone
13352070835
Email
jieruke@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi Guo, MD
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi Guo, MD
Phone
13920076145
Email
cjr.guozhi@vip.163.com
First Name & Middle Initial & Last Name & Degree
Haipeng Yu, MD
Phone
13352070835
Email
jieruke@yahoo.com.cn

12. IPD Sharing Statement

Links:
URL
http://www.tjmuch.com/
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs