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   20世纪70年代,单克隆抗体这一名词开始出现,科学家们意识到它可以针对肿瘤特异性分子进行严厉打击,这一发现也逐渐引发癌症治疗的新变革。作为中国生物制药的企业——百泰生物药业有限公司,从1999年起,开始尝试单克隆抗体药物在癌症治疗领域的临床应用。在2008年4月,泰欣生(尼妥珠单抗)正式上市,它是一个以EGFR为靶点的人源化单抗药物。

您现在的位置:首页 >> 医患之家 >> 学术进展 >> 尼妥珠单抗联合放化疗治疗局部晚期食管鳞癌的剂量爬坡的Ⅰ期临床研究

尼妥珠单抗联合放化疗治疗局部晚期食管鳞癌的剂量爬坡的Ⅰ期临床研究

日期:2016年1月18日 21:33

A Phase I Dose Escalation Study Of Nimotuzumab In Combination With Concurrent Chemoradiotherapy For Patient With Locally Advanced Squamous Cell Cancer Of  Esophagus
Control/Tracking Number: 2011-A-1759-ASTRO
    Author Block: K. Zhao, G. Jiang, X. Hu, X. Wu, X. Fu, M. Fan, Fudan University Shanghai Cancer Center, Shanghai, China
    Purpose/Objective(s): To assess the safety, maximal tolerance dose (MTD) and preliminary efficacy of Nimotuzumab, a humanized anti-epidermal growth factor receptor monoclonal antibody, in combination with concurrent chemoradiotherapy in patient with locally advanced ESO.
    Materials/Methods: Patients age 18-75 years with locally advanced ESO were eligible for this study. Radiation: 3D CRT or IMRT, with a total dose of 61.2Gy/34fx. Concurrent chemotherapy and Nimotuzumab administration began at the first day of radiotherapy. Chemotherapy: DDP 25mg/m2/d, d1-3; 5-FU 600 mg/m2/d, iv, d1-3 (PICC); 1 cycle/4 wks, 4 cycles. Escalating  fixed-dose of Nimotuzumab (100, 200 and 400mg/wk) was administered in each dose group in a cohort study. The primary endpoints were safety and early efficacy. The data analysis was based on ITT group. The protocol has gained the IRB permission. All participants in the trial have signed the consent forms, voluntarily. The trial has been registered on ClinicalTrials.gov (NO: NCT00950417), and the SFDA clinical trial approve (No: 2008L04846).
    Results: From July 2009 to June 2010, 11 patients were enrolled (100mg 3 patients, 200mg 4 patients, 400mg 4 patients), including 2 withdrawls (200mg and 400mg). One withdrawl has already received 50.4Gy/28Fx radiation, 2 cycles of chemotherapy and 6 times of Nimotuzumab (400mg/wk). Nine non-withdrawls have completed the radiotherapy and Nimotuzumab treatment, seven received 4 cycles of chemotherapy, one received 3 cycles and one for 2 cycles. None of the 11 patients reached DLT. One grade 1 skin rash occurred (1/11). The incidence rate of grade 3-4 esophagitis, grade 3 leucocytopenia and neutrocytopenia were 18.2%(2/11), 18.2%(2/11)and 9.0%(1/11). No grade 3 or higher Nimotuzumab-related toxicity was observed. Median follow-up was 10.4 months (9.5-18.0 months), while 4/11 patients died. The CR, PR SD and PD were 22.2%(2/9), 55.6%(5/9), 11.1%(1/9) and 11.1%(1/9) in 9 patients. While the CR, PR SD and PD were 20.8 %(2/10), 50.0 %(5/10), 20.0 %(2/10) and 10.0 %(1/10) in 10 patients who received 6 weeks Nimotuzumab, respectively. 5 out of 10 patients relapsed or died (4 distant metastasis, 1 esophagus hemorrhea). Six months and 1 year survival rates were 80% and 70%. Six months and 1 year progression-free survival (PFS) rates were 80% and 60%, respectively. 1 year local progression-free survival was 100%.
    Conclusion: Nimotuzumab administered 400mg weekly with concurrent chemoradiotherapy based on PF regimen was well-tolerant. No SAE related to Nimotuzumab was observed. MTD has not reached yet across the test doses in this study. This initial study represents a higher local control rate and survival in the treatment of locally advanced esophageal cancer.

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