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Transcatheter Arterial Chemoembolization With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas (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 SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Tianjin Medical University Cancer 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(withou 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
remiision rate

Full Information

First Posted
July 11, 2011
Last Updated
June 9, 2017
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01393093
Brief Title
Transcatheter Arterial Chemoembolization With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas
Acronym
TACE-KMG
Official Title
Clinical Trial of Transcatheter Arterial Chemoembolization 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 (Actual)
Study Completion Date
December 2018 (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 the study is to evaluate the effects of Transcatheter Arterial Chemoembolization (TACE) with KMG microsphere in treating advance-stage Hepatocellular Carinoma(HCC).
Detailed Description
This is a prospective, multicentre, random, controlled clinical trial of Transcatheter Arterial Chemoembolization (TACE)with KMG Microsphere Treating Advance-stage Hepatocellular Carinomas.

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
2840 (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(withou chemo)
Arm Type
Experimental
Arm Description
embolization agent:KMG microsphere( 150-450µm,0.2-2g)
Intervention Type
Procedure
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 year
Title
remission rate
Description
remiision 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
Accepts Healthy Volunteers
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 Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tianjin Medical University Cancer 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
First Name & Middle Initial & Last Name & Degree
Wenge Xing, MD

12. IPD Sharing Statement

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

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

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