Clinical Research of Licartin Combined With TACE in the Treatment of Unresectable Hepatocellular Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Eastern Hepatobiliary Surgery Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT00829465
First received: December 22, 2008
Last updated: January 26, 2009
Last verified: January 2009

December 22, 2008
January 26, 2009
December 2008
December 2009   (final data collection date for primary outcome measure)
OS of 1 years; TTP [ Time Frame: 2008.12--2010-12 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00829465 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Research of Licartin Combined With TACE in the Treatment of Unresectable Hepatocellular Carcinoma
Clinical Research of in the Treatment of Unresectable Hepatocellular Carcinoma

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Unresectable Hepatocellular Carcinoma
  • Drug: Licartin
    Licartin
    Other Name: TACE and Licartin
  • Procedure: Transcatheter arterial chemoembolization
    TACE
    Other Name: Transcatheter arterial chemoembolization
  • Active Comparator: control
    Intervention: Procedure: Transcatheter arterial chemoembolization
  • Experimental: therapy
    Interventions:
    • Drug: Licartin
    • Procedure: Transcatheter arterial chemoembolization
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
December 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. the participation is entirely voluntary, good at compliance, sign the informed consent form in person;
  2. diagnosed to be hepatocellular carcinoma by clinical method, imaging method and tumor markers; and the surgeons determine who can not undergo surgery;
  3. confirmed to recurrent after surgery by pathology;
  4. KPS score of physical state ≥ 60 points;
  5. liver function is Child-Pugh A or B class

Exclusion Criteria:

  1. General situation is poor and liver function Child-Pugh is C class;
  2. there is a serious heart, kidney and blood system diseases in patients;
  3. poor compliance;
  4. there is allergy history of biological agents or in a state of allergy;
  5. pregnancy and breast-feeding women
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00829465
EHBH-RCT-2008-013
Yes
Yang-yefa, EHBH
Eastern Hepatobiliary Surgery Hospital
Not Provided
Study Director: Yang yefa, doctor The Second Military Medical University
Eastern Hepatobiliary Surgery Hospital
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP