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

June 27, 2011 updated by: Changhai Hospital

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

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

284

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Department of TCM, Changhai Hospital of Shanghai
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD.
Nov. 2010 to Nov. 2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Ling chang quan, doctor, Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

November 8, 2010

First Posted (Estimate)

November 9, 2010

Study Record Updates

Last Update Posted (Estimate)

June 28, 2011

Last Update Submitted That Met QC Criteria

June 27, 2011

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLing

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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