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

Unresectable Hepatocellular Carcinoma Clinical Trial

Official title:

Clinical Research of in the Treatment of Unresectable Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829465
• Other study ID #: EHBH-RCT-2008-013
• Status: Completed
• Phase: Phase 4
• First received: December 22, 2008
• Last updated: March 30, 2016
• Start date: December 2008
• Est. completion date: December 2010

Study information

• Verified date: March 2016
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Unresectable Hepatocellular Carcinoma

Intervention

Drug:
• Licartin
Licartin

Procedure:
• Transcatheter arterial chemoembolization
TACE

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS of 1 years; TTP		2008.12--2010-12	Yes