A Clinical Trail of Iodine[131I] Metuximab Injection With CIK Cells for Preventing Hepatocellular Carcinoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Clinical Trail of Iodine[131I] Metuximab Injection With CIK Cells for Preventing Relapse and Metastasis of Hepatocellular Carcinoma|
- Progression-free survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Experimental: Licartin，Licartin and CIK
Intravenous Licartin 27.75 M Bq(0.75 mCi)/kg Licartin and CIK
Biological: Licartin and CIK
Licartin and CIK
Primary liver cancer (hereinafter abbreviated as PLC) is one of the most common types of malignant tumors in clinical practices. Its global prevalence is rising year-on-year and surpasses 626,000 per year. Ranking at No. 5 among all malignant tumors, its mortality rate approaches 600,000 per year and becomes No.3 of tumor-related death. As one of the prevalent regions of PLC in the world, China has a morbidity population of around 55%. Among the tumor-related death, it stands at No. 2 second only to lung cancer. So PLC has been a major hazard to health and life for Chinese citizens. Surgical resection has remained the first therapeutic choice of PLC. However, the disease course of PLC is insidious. In clinical practices, less than 30% of PLC patients may be treated surgically by hepatectomy. And their postoperative occurrences of recurrence and metastasis stay at a high level. As demonstrated by large-sample clinical trials in China, the 5-year postoperative recurrent rate of PLC was as high as 61.5%. The relevant studies have indicated that the surgical therapy of PLC has encountered a bottle-neck over the last decade and the control rates of postoperative recurrence or metastasis remain basically the same. Therefore the recurrence and metastasis of PLC are important limiting factors for its clinical therapeutic gains. Effectively lowering the post-therapeutic recurrence and metastasis of PLC has become a breakthrough point for improved clinical efficacies. At present, there is still no standard therapeutic protocol for the prevention of recurrence and metastasis of PLC.
Independently developed recently by China, licartin has been the first radioimmunological targeted therapeutic agent approved for PLC in the world. Since its marketing in 2007, it has achieved excellent clinical efficacies and social recognition. As demonstrated by the results of relevant basic and clinical researches, licartin had definite efficacies for primary hepatocellular carcinoma and it could boost the efficacies of integrated PLC therapy, prolong the patient survivals and enhance the benefits of clinical therapeutics. Early studies have also proved that it could prolong the survivals of PLC, improve the quality of life and prevent the postoperative recurrence and metastasis. The present clinical trial is intended to examine the efficacy and safety of radioimmunotherapy via intravenous infusion of licartin plus sequential immunotherapy of CIK cell in the controls of disease progression, effective prolonging of recurrent time and prevention of recurrence or metastasis of primary hepatocellular carcinoma.
This clinical trial is designed to provide one kind of modalities for preventing the recurrence and metastasis of PLC. If the expected therapeutic efficacy is achieved, it shall contribute actively to boosting the therapeutic level of PLC, prolonging its recurrent time and enhancing its overall survival. And it may also raise the clinical recognition of this technology, promote its clinical applications and generate excellent social reputations and economic returns.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758679
|Tianjin Medical University Cancer Institute and Hospital||Recruiting|
|Tianjin, Tianjin, China, 300060|
|Contact: Yan Zhao, Doctor 022-23340123 ext 6012 firstname.lastname@example.org|
|Study Director:||Yan Zhao, Doctor||Director of Pharmacology Base|