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

NCT00829465 | Completed Phase 4 DMC

• 1 other identifier: EHBH-RCT-2008-013
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Unresectable Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• OS of 1 years; TTP

  2008.12--2010-12

Study Arms (2)

control

ACTIVE COMPARATOR

Procedure: Transcatheter arterial chemoembolization

therapy

EXPERIMENTAL

Drug: Licartin; Procedure: Transcatheter arterial chemoembolization

Interventions

Licartin DRUG

Licartin

Also known as: TACE and Licartin

therapy

Transcatheter arterial chemoembolization PROCEDURE

TACE

control; therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• General situation is poor and liver function Child-Pugh is C class;
• there is a serious heart, kidney and blood system diseases in patients;
• poor compliance;
• there is allergy history of biological agents or in a state of allergy;
• pregnancy and breast-feeding women

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

MeSH Terms

Interventions

metuximab

Study Officials

• Yang yefa, doctor

  Second Military Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of the Eastern Hepatobiliary Surgery Hospotal

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: January 27, 2009
• Study Start: December 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: April 1, 2016

Record last verified: 2016-03