Clinical Research of Licartin Combined With TACE in the Treatment of Unresectable Hepatocellular Carcinoma
Condition: Unresectable Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Licartin; Transcatheter arterial chemoembolization
Intervention type(s): Drug; Procedure
Intervention description(s): Licartin; TACE
Other intervention name(s): TACE and Licartin
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment