NCT00829465

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

Clinical Research of in the Treatment of Unresectable Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Eastern Hepatobiliary Surgery Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unresectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Licartin	Licartin
PROCEDURE	Transcatheter arterial chemoembolization	TACE

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-12-01
• Completion: 2010-12-01
• First posted: 2009-01-27
• Last updated: 2016-04-01