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Status unknownNCT01393093TACE-KMGUpdated Jun 12, 2017

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

An interventional study of Therapeutic Chemoembolization in Carcinoma, Hepatocellular, sponsored by Tianjin Medical University Cancer Institute and Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-12.

Sponsored by Tianjin Medical University Cancer Institute and Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
2,840
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

Read the detailed description

This is a prospective, multicentre, random, controlled clinical trial of Transcatheter Arterial Chemoembolization (TACE)with KMG Microsphere Treating Advance-stage Hepatocellular Carinomas.

02

Conditions studied

  • Carcinoma, Hepatocellular

Keywords

  • HCC
  • TACE
03

In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.

This study's planned enrollment of 2,840 is above the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Investigator)
Enrollment
2,840 participants (estimated)

Study arms

  • 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

    Procedure: Therapeutic Chemoembolization

  • Experimental
    TACE-KMG ( routine dose Chemo)

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

    Procedure: Therapeutic Chemoembolization

  • Experimental
    TACE-KMG( low dose Chemo )

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

    Procedure: Therapeutic Chemoembolization

  • Experimental
    TACE-KMG(withou chemo)

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

    Procedure: Therapeutic Chemoembolization

Interventions

  • ProcedureTherapeutic Chemoembolization

    Transcatheter Arterial Chemoembolization

    Also known as: Transcatheter Arterial Chemoembolization，TACE

06

What researchers measure

Primary outcomes

  1. Time to progression

    Time to progression

    Time frame: 3 years

Secondary outcomes

  1. total survival

    total survival

    Time frame: 3 year

  2. remission rate

    remiision rate

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Tianjin Medical University Cancer Hospital
    Tianjin, Tianjin 300060, China
    Recruiting
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01393093
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Responsible party
Sponsor
First posted
Jul 13, 2011
Start date
Mar 2011
Primary completion
Nov 2016
Completion
Dec 2018 (estimated)
Last update
Jun 12, 2017

Study contacts

Zhi Guo, MD
Contact
cjr.guozhi@vip.163.com
13920076145
Haipeng Yu, MD
Contact
jieruke@yahoo.com.cn
13352070835
Zhi Guo, MD
study chair · Tianjin Medical University Cancer Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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