Clinical Research of Licartin Combined With TACE in the Treatment of Unresectable Hepatocellular Carcinoma
Primary Purpose
Unresectable Hepatocellular Carcinoma
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Licartin
Transcatheter arterial chemoembolization
Sponsored by

About this trial
This is an interventional treatment trial for Unresectable Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- the participation is entirely voluntary, good at compliance, sign the informed consent form in person;
- diagnosed to be hepatocellular carcinoma by clinical method, imaging method and tumor markers; and the surgeons determine who can not undergo surgery;
- confirmed to recurrent after surgery by pathology;
- KPS score of physical state ≥ 60 points;
- liver function is Child-Pugh A or B class
Exclusion Criteria:
- General situation is poor and liver function Child-Pugh is C class;
- there is a serious heart, kidney and blood system diseases in patients;
- poor compliance;
- there is allergy history of biological agents or in a state of allergy;
- pregnancy and breast-feeding women
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control
therapy
Arm Description
Outcomes
Primary Outcome Measures
OS of 1 years; TTP
Secondary Outcome Measures
Full Information
NCT ID
NCT00829465
First Posted
December 22, 2008
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00829465
Brief Title
Clinical Research of Licartin Combined With TACE in the Treatment of Unresectable Hepatocellular Carcinoma
Official Title
Clinical Research of in the Treatment of Unresectable Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Liver cancer is a highly invasive malignancy and the rate of surgical resection is no more than 28%. After diagnosis, the average survival rate of patient is less than 50% in 6 month, less than 24% in 1 year and 5% in 5 year. The TACE treatment, under the theoretical basis of blood supply of Liver cancer, is obviously better than the other non-surgical therapy, in terms of tumor regression, AFP decrease, survival time and the evaluation of the quality of life. However, its overall effect is not yet satisfactory. As a result, concerning the research of drug for liver cancer and improving the overall efficacy of the treatment of liver cancer has a very real and important clinical significance and social value. Licartin (Iodine-131-Labeled Metuximab) injection is a antibody drug with new target and the only drug that China own the intellectual property rights. It has specific high affinity with HAb18G/CD147, the liver cell membrane antigen. Labeled 131I is taken to the liver tissue, owning high-dose concentration and releasing β particles to liver cancer cells to and kill cancer cells.
The Second Military Medical University, Eastern Hepatobiliary Surgery Hospital, planed to use the treatment of Licartin combined with TACE for the patients of unresectable hepatocellular carcinoma and evaluate the difference of tumor size, AFP change, TTP, the overall survival rate between different treatment group.
Detailed Description
Liver cancer is a highly invasive malignancy and the rate of surgical resection is no more than 28%. The TACE treatment, under the theoretical basis of blood supply of Liver cancer, is obviously better than the other non-surgical therapy, in terms of tumor regression, AFP decrease, survival time and the evaluation of the quality of life. Licartin injection is a antibody drug with new target and the only drug that China own the intellectual property rights. It has specific high affinity with HAb18G/CD147, the liver cell membrane antigen. Labeled 131I is taken to the liver tissue, owning high-dose concentration and releasing β particles to liver cancer cells to and kill cancer cells.
The Second Military Medical University, Eastern Hepatobiliary Surgery Hospital, planed to use the treatment of Licartin combined with TACE for the patients of unresectable hepatocellular carcinoma and evaluate the difference of tumor size, AFP change, TTP, the overall survival rate between different treatment group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Active Comparator
Arm Title
therapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Licartin
Other Intervention Name(s)
TACE and Licartin
Intervention Description
Licartin
Intervention Type
Procedure
Intervention Name(s)
Transcatheter arterial chemoembolization
Intervention Description
TACE
Primary Outcome Measure Information:
Title
OS of 1 years; TTP
Time Frame
2008.12--2010-12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
the participation is entirely voluntary, good at compliance, sign the informed consent form in person;
diagnosed to be hepatocellular carcinoma by clinical method, imaging method and tumor markers; and the surgeons determine who can not undergo surgery;
confirmed to recurrent after surgery by pathology;
KPS score of physical state ≥ 60 points;
liver function is Child-Pugh A or B class
Exclusion Criteria:
General situation is poor and liver function Child-Pugh is C class;
there is a serious heart, kidney and blood system diseases in patients;
poor compliance;
there is allergy history of biological agents or in a state of allergy;
pregnancy and breast-feeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang yefa, doctor
Organizational Affiliation
Second Military Medical University
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Clinical Research of Licartin Combined With TACE in the Treatment of Unresectable Hepatocellular Carcinoma
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