研究单位：[1]Shandong Cancer Hospital and Institute[2]Beijing Cancer Hospital Beijing, Beijing, China, 100142[3]Cancer Hospital of Shantou University Medical College Shantou, Guangdong, China, 515041[4]The Guangxi Zhuang Autonomous Region Cancer Hospita Nanning, Guangxi, China, 530021[5]Affiliated Hospital of Zunyi Medical College Zunyi, Guizhou, China, 563099[6]Fourth Hospital of Hebei Medical University Tumor Shijiazhuang, Hebei, China, 50011河北医科大学第四医院[7]Henan Cancer Hospital Zhengzhou, Henan, China, 450008[8]Jiangsu Cancer Hospital Nanjing, Jiangsu, China, 210000[9]Affiliated Hospital of Jiangsu University Zhenjiang, Jiangsu, China, 212013[10]The First Hospital of China Medical University Shenyang, Liaoning, China, 310022[11]Cancer Hospital Chinese Academy of Medical Sciences Beijing, Beijing, China, 100021[12]Renji Hospital Shanghai Jiao Tong University School of Medicine Shanghai, Shanghai, China, 200127[13]The First Hospital of Zhejiang Province Hangzhou, Zhejiang, China, 310003[14]Zhejiang Cancer Hospital Hangzhou, Zhejiang, China, 310022
研究目的：
Esophageal cancer is the sixth leading cause of cancer death in worldwide. Over the past 2 decades, well-designed clinical trials have documented the clinical benefits of combination of chemotherapy and radiation for localized esophageal cancer, either as primary therapy or in neoadjuvant setting. Paclitaxel, a radiation sensitizer, has important single-agent activity in esophageal cancer. Paclitaxel-based chemoradiation has been the framework for the recent Radiation Therapy Oncology Group (RTOG) trials of nonoperative management of esophageal cancer. Accumulating clinical evidence suggests that Epidermal Growth Factor Receptor (EGFR) represents a viable target in the treatment of esophageal cancer. EGFR expression is associated with poor prognosis. Nimotuzumab binds specifically to EGFR on both normal and tumor cells and competitively inhibits the binding of Epidermal Growth Factor (EGF) and other ligands, such as Transforming Growth Factor-α (TGF-α). Preclinical models have suggested synergy between nimotuzumab, paclitaxel, cisplatin and radiation. For our phase II study in locally advanced esophageal squamous cell carcinoma (ESCC), the combination of cetuximab and chemoradiotherapy has demonstrated both response and survival benefits. Myara et al reported that nimotuzumab plus concurrent chemoradiation therapy (CCRT) was safe and provided statistically significant objective response (47.8%) and disease control rate (60.9%) in nonresectable ESCC. With all these, the investigators plan to study phase III trial.
