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

Primary Purpose

Hepatoma, Cinobufacin Injection

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Cinobufacin injection
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatoma focused on measuring Transcatheter arterial embolization, Cinobufacin injection, hepatoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of TCM, Changhai Hospital of ShanghaiRecruiting

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
November 8, 2010
Last Updated
June 27, 2011
Sponsor
Changhai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01236690
Brief Title
Study of Hepatoma Treated by Perfusing Cinobufacin Through Hepatic Artery Combining Embolotherapy
Official Title
The Clinical Research of the Intermediate and Advanced Hepatoma Treated by Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
November 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Changhai Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 .
Detailed Description
Inclusion criterion : The sex does not limit, age:18-70 years old . The patients have inoperable advanced hepatoma without serious disorder in liver and renal, tumor occupation< 70 % The patients have failure in surgical intervention or resection operation recidivist Hepatic function Child-pugh A、B All the cases have the definite final diagnosis of imageology results such as MRI、CT 、B ultrasonic or cytology results The patient's prediction of live time>6 months, who can tolerant of TACE and has quality of life ECOG score<3 The patients participate the clinical trial voluntarily and have already signed informed consent Exclusion criterion : Main portal vein was obstructed completely. The occupation of tumor are 70 % or more than 70 % in the whole liver The patient has TACE or other antineoplaston After carcinosectomy the patient has the prophylactic The patient is with renal inadequacy: Cr≥133 umol/L Severe cardiovascular disease The patient is with other diseases to influence the proposal

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatoma, Cinobufacin Injection
Keywords
Transcatheter arterial embolization, Cinobufacin injection, hepatoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
284 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cinobufacin injection
Other Intervention Name(s)
Z34020273
Intervention Description
Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy
Primary Outcome Measure Information:
Title
The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The sex does not limit, age:18-70 years old ; The patients have inoperable advanced hepatoma without serious disorder in liver and renal, tumor occupation< 70 %; The patients have failure in surgical intervention or resection operation recidivist; Hepatic function Child-pugh A、B; All the cases have the definite final diagnosis of imageology results such as MRI、CT 、B ultrasonic or cytology results ; The patient's prediction of live time>6 months, who can tolerant of TACE and has quality of life ECOG score<3; The patients participate the clinical trial voluntarily and have already signed informed consent. Exclusion Criteria: Main portal vein was obstructed completely; The occupation of tumour are 70 % or more than 70 % in the whole liver; The patient has recepted TACE or other antineoplaston; After carcinosectomy the patient has the prophylactic; The patient is with renal inadequacy: Cr≥133 umol/L Severe cardiovascular disease; The patient is with other diseases to influence the proposal; All over the body generally have metabasis or be with other malignant neoplastic disease; In the process of participation of other medicinal trial; Gravidity, lactation ,hypersensitiveness constitution or have already known adverse reaction or taboo.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ling chang quan, doctor
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of TCM, Changhai Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
changquan Ling, Doctor
Phone
+86 21 81873539
Email
qiaocuixia@126.com

12. IPD Sharing Statement

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

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