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


N/A
18 Years
75 Years
Open (Enrolling)
Both
Carcinoma, Hepatocellular

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time to progression

Outcome Description:

Time to progression

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Zhi Guo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Tianjin Medical University Cancer Hospital

Authority:

China: Ethics Committee

Study ID:

TMU-CIH-IR-002

NCT ID:

NCT01393093

Start Date:

March 2011

Completion Date:

March 2014

Related Keywords:

  • Carcinoma, Hepatocellular
  • HCC
  • TACE
  • Carcinoma
  • Carcinoma, Hepatocellular

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