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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Unresectable Hepatocellular Carcinoma
 Drug: Licartin
Procedure: Transcatheter arterial chemoembolization
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Research of in the Treatment of Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:

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

Further study details as provided by Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:
  • OS of 1 years; TTP [ Time Frame: 2008.12--2010-12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: December 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: control Procedure: Transcatheter arterial chemoembolization
TACE
Other Name: Transcatheter arterial chemoembolization
Experimental: therapy Drug: Licartin
Licartin
Other Name: TACE and Licartin
Procedure: Transcatheter arterial chemoembolization
TACE
Other Name: Transcatheter arterial chemoembolization

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829465

Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
Study Director: Yang yefa, doctor The Second Military Medical University
  More Information

No publications provided

Responsible Party: Yang-yefa, EHBH
ClinicalTrials.gov Identifier: NCT00829465     History of Changes
Other Study ID Numbers: EHBH-RCT-2008-013
Study First Received: December 22, 2008
Last Updated: January 26, 2009
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013