1. Targeting radioimmunotherapy of hepatocellular carcinoma with iodine (131I) metuximab injection: Clinical Phase I/II trials
- Author
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Airong Qian, Yunchun Li, Xiang-Min Yang, Huijie Bian, Nan Leng, Fei Song, Qing Zhang, Guo-Hui Xu, Xiao-Ling Yu, Yu Li, Ping Zhu, Rong Tian, Peng Shang, Hongxin Zhang, De-Rong Liang, Sihe Zhang, Anren Kuang, Zhenbiao Wu, Jia Miao, Tingshu Mo, Zhi-Hui Zhang, Jinliang Xing, Li Mi, Qing-Guang Liu, Jian-Li Jiang, Han Jun, Zhi-Nan Chen, Yuan Feng, Jing Xu, Kejun Nan, Tianzhi Tan, Zheng Zhang, Qiang Feng, Ling Li, Xian-Hui Wang, and Wusheng Lu
- Subjects
Adult ,Male ,Cancer Research ,medicine.medical_specialty ,Carcinoma, Hepatocellular ,Adolescent ,Maximum Tolerated Dose ,medicine.medical_treatment ,Antineoplastic Agents ,Gastroenterology ,law.invention ,Iodine Radioisotopes ,Pharmacokinetics ,Randomized controlled trial ,law ,Internal medicine ,Carcinoma ,Humans ,Medicine ,Radiology, Nuclear Medicine and imaging ,Survival rate ,Aged ,Radiation ,business.industry ,Liver Neoplasms ,Antibodies, Monoclonal ,Middle Aged ,Radioimmunotherapy ,medicine.disease ,Surgery ,Clinical trial ,Drug Combinations ,Oncology ,Hepatocellular carcinoma ,Basigin ,Female ,business ,Progressive disease - Abstract
Purpose: HAb18G/CD147 is a hepatocellular carcinoma (HCC)-associated antigen. We developed iodine ( 131 I) metuximab injection (Licartin), a novel 131 I-labeled HAb18G/CD147-specific monoclonal antibody F(ab') 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 p = 0.0019). Conclusion: Iodine ( 131 I) metuximab injection is safe and active for HCC patients.
- Published
- 2006