NCT01393197

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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2011

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 18, 2015

Status Verified

November 1, 2010

Enrollment Period

5.7 years

First QC Date

July 11, 2011

Last Update Submit

December 17, 2015

Conditions

Carcinoma, Hepatocellular

Keywords

HCCTACE

Outcome Measures

Primary Outcomes (1)

  • Time to progression

    Time to progression

    3 years

Secondary Outcomes (2)

  • total survival

    3 years

  • remission rate

    3 years

Study Arms (4)

TACE -oil

ACTIVE COMPARATOR

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

Other: Therapeutic Chemoembolization

TACE-KMG ( routine dose Chemo)

EXPERIMENTAL

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

Other: Therapeutic Chemoembolization

TACE-KMG( low dose Chemo )

EXPERIMENTAL

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

Other: Therapeutic Chemoembolization

TACE-KMG(without chemo)

EXPERIMENTAL

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

Other: Therapeutic Chemoembolization

Interventions

Therapeutic ChemoembolizationOTHER

Transcatheter Arterial Chemoembolization

Also known as: Transcatheter Arterial Chemoembolization，TACE
TACE -oilTACE-KMG ( routine dose Chemo)TACE-KMG( low dose Chemo )TACE-KMG(without chemo)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Related Links

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Chemoembolization, Therapeutic

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Embolization, TherapeuticHemostatic TechniquesTherapeuticsTherapeutic Occlusion

Study Officials

  • Zhi Guo, MD

    Tianjin Medical University Cancer Institute and Hospital

    STUDY CHAIR

Central Study Contacts

Zhi Guo, MD

CONTACT

13920076145cjr.guozhi@vip.163.com

Haipeng Yu, MD

CONTACT

13352070835jieruke@yahoo.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 13, 2011

Study Start

March 1, 2011

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

December 18, 2015

Record last verified: 2010-11

Locations

CN(1)