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The Clinical Research of the Intermediate and Advanced Hepatoma Treated by Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Hepatoma, Cinobufacin Injection

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Trial Information

The Clinical Research of the Intermediate and Advanced Hepatoma Treated by Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy


Inclusion criterion :

1. The sex does not limit, age:18-70 years old .

2. The patients have inoperable advanced hepatoma without serious disorder in liver and
renal, tumor occupation< 70 %

3. The patients have failure in surgical intervention or resection operation recidivist

4. Hepatic function Child-pugh A、B

5. All the cases have the definite final diagnosis of imageology results such as MRI、CT 、B
ultrasonic or cytology results

6. The patient's prediction of live time>6 months, who can tolerant of TACE and has
quality of life ECOG score<3

7. The patients participate the clinical trial voluntarily and have already signed
informed consent

Exclusion criterion :

1. Main portal vein was obstructed completely.

2. The occupation of tumor are 70 % or more than 70 % in the whole liver

3. The patient has TACE or other antineoplaston

4. After carcinosectomy the patient has the prophylactic

5. The patient is with renal inadequacy: Cr≥133 umol/L

6. Severe cardiovascular disease

7. The patient is with other diseases to influence the proposal


Inclusion Criteria:



1. The sex does not limit, age:18-70 years old ;

2. The patients have inoperable advanced hepatoma without serious disorder in liver and
renal, tumor occupation< 70 %;

3. The patients have failure in surgical intervention or resection operation recidivist;

4. Hepatic function Child-pugh A、B;

5. All the cases have the definite final diagnosis of imageology results such as MRI、CT
、B ultrasonic or cytology results ;

6. The patient's prediction of live time>6 months, who can tolerant of TACE and has
quality of life ECOG score<3;

7. The patients participate the clinical trial voluntarily and have already signed
informed consent.

Exclusion Criteria:

1. Main portal vein was obstructed completely;

2. The occupation of tumour are 70 % or more than 70 % in the whole liver;

3. The patient has recepted TACE or other antineoplaston;

4. After carcinosectomy the patient has the prophylactic;

5. The patient is with renal inadequacy: Cr≥133 umol/L

6. Severe cardiovascular disease;

7. The patient is with other diseases to influence the proposal;

8. All over the body generally have metabasis or be with other malignant neoplastic
disease;

9. In the process of participation of other medicinal trial;

10. Gravidity, lactation ,hypersensitiveness constitution or have already known adverse
reaction or taboo.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD.

Outcome Description:

The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD.

Outcome Time Frame:

Nov. 2010 to Nov. 2013

Safety Issue:

Yes

Principal Investigator

Ling chang quan, doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Changhai Hospital, Second Military Medical University

Authority:

China:Changhai Hospital ethics committee

Study ID:

CLing

NCT ID:

NCT01236690

Start Date:

November 2010

Completion Date:

November 2013

Related Keywords:

  • Hepatoma
  • Cinobufacin Injection
  • Transcatheter arterial embolization
  • Cinobufacin injection
  • hepatoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

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