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Study of Hepatoma Treated by Perfusing Cinobufacin Through Hepatic Artery Combining Embolotherapy

This study is currently recruiting participants.
Verified October 2010 by Changhai Hospital
Sponsor:
Information provided by:
Changhai Hospital
ClinicalTrials.gov Identifier:
NCT01236690
First received: November 8, 2010
Last updated: June 27, 2011
Last verified: October 2010
History of Changes
  Purpose

Cinobufacini has the effects of anticancer, improving the liver function, elevation of immunity and little side effects, and is important and significant for the patients with hepatitis, liver cirrhosis and hepatomas.

Compared with transarterial chemoembolization (TACE) , the clinical effect of cinobufacini is non-inferior/ equivalent.Compared with TACE, cinobufacini is superior in security .


Condition Intervention Phase
Hepatoma
Cinobufacin Injection
 Drug: Cinobufacin injection
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Clinical Research of the Intermediate and Advanced Hepatoma Treated by Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy

Resource links provided by NLM:

MedlinePlus related topics: Liver Cancer
U.S. FDA Resources

Further study details as provided by Changhai Hospital:

Primary Outcome Measures:
  • The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD. [ Time Frame: Nov. 2010 to Nov. 2013 ] [ Designated as safety issue: Yes ]
    The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD.


Estimated Enrollment: 284
Study Start Date: November 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cinobufacin injection
    Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy
    Other Name: Z34020273
Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01236690

Locations
China, Shanghai
Department of TCM, Changhai Hospital of Shanghai Recruiting
Shanghai, Shanghai, China, 200433
Contact: changquan Ling, Doctor     +86 21 81873539     qiaocuixia@126.com    
Sponsors and Collaborators
Changhai Hospital
Investigators
Principal Investigator: Ling chang quan, doctor Changhai Hospital, Second Military Medical University,
  More Information

No publications provided

Responsible Party: Changquan Ling, Department of TCM, Shanghai Changhai Hospital
ClinicalTrials.gov Identifier: NCT01236690     History of Changes
Other Study ID Numbers: CLing
Study First Received: November 8, 2010
Last Updated: June 27, 2011
Health Authority: China:Changhai Hospital ethics committee

Keywords provided by Changhai Hospital:
Transcatheter arterial embolization
Cinobufacin injection
hepatoma

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 16, 2013