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Targeting radioimmunotherapy of hepatocellular carcinoma with iodine (131I) metuximab injection: clinical phase I/II trials.
Chen, Zhi-Nan; Mi, Li; Xu, Jing; Song, Fei; Zhang, Qing; Zhang, Zheng; Xing, Jin-Liang; Bian, Hui-Jie; Jiang, Jian-Li; Wang, Xian-Hui; Shang, Peng; Qian, Ai-Rong; Zhang, Si-He; Li, Ling; Li, Yu; Feng, Qiang; Yu, Xiao-Ling; Feng, Yuan; Yang, Xiang-Min; Tian, Rong; Wu, Zhen-Biao; Leng, Nan; Mo, Ting-Shu; Kuang, An-Ren; Tan, Tian-Zhi; Li, Yun-Chun; Liang, De-Rong; Lu, Wu-Sheng; Miao, Jia; Xu, Guo-Hui; Zhang, Zhi-Hui; Nan, Ke-Jun; Han, Jun; Liu, Qing-Guang; Zhang, Hong-Xin; Zhu, Ping.
Afiliación
  • Chen ZN; Cell Engineering Research Centre and Department of Cell Biology, State Key Laboratory of Cancer Biology, Fourth Military Medical University, Xi'an, China.
Int J Radiat Oncol Biol Phys ; 65(2): 435-44, 2006 Jun 01.
Article en En | MEDLINE | ID: mdl-16690431
PURPOSE: HAb18G/CD147 is a hepatocellular carcinoma (HCC)-associated antigen. We developed iodine (131I) metuximab injection (Licartin), a novel 131I-labeled HAb18G/CD147-specific monoclonal antibody Fab'2 fragment, and evaluated its safety, pharmacokinetics, and clinical efficacy on HCC in Phase I/II trials. METHODS AND MATERIALS: In a Phase I trial, 28 patients were randomly assigned to receive the injection in 9.25-, 18.5-, 27.75-, or 37-MBq/kg doses by hepatic artery infusion. In a multicenter Phase II trial, 106 patients received the injection (27.75 MBq/kg) on Day 1 of a 28-day cycle. Response rate and survival rate were the endpoints. RESULTS: No life-threatening toxic effects were found. The safe dosage was 27.75 MBq/kg. The blood clearance fitted a biphasic model, and its half-life was 90.56-63.93 h. In the Phase II trial, the injection was found to be targeted and concentrated to tumor tissues. Of the 73 patients completing two cycles, 6 (8.22%) had a partial response, 14 (19.18%) minor response, and 43 (58.90%) stable disease. The 21-month survival rate was 44.54%. The survival rate of progression-free patients was significantly higher than that of patients with progressive disease after either one or two cycles (p < 0.0001 or p = 0.0019). CONCLUSION: Iodine (131I) metuximab injection is safe and active for HCC patients.
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Radioinmunoterapia / Carcinoma Hepatocelular / Basigina / Radioisótopos de Yodo / Neoplasias Hepáticas / Anticuerpos Monoclonales / Antineoplásicos Tipo de estudio: Clinical_trials Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Int J Radiat Oncol Biol Phys Año: 2006 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos
Buscar en Google
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PubMed Links

Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Radioinmunoterapia / Carcinoma Hepatocelular / Basigina / Radioisótopos de Yodo / Neoplasias Hepáticas / Anticuerpos Monoclonales / Antineoplásicos Tipo de estudio: Clinical_trials Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Int J Radiat Oncol Biol Phys Año: 2006 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos