泰欣生 h-R3 临床试验总结(幻灯)(2)

PDF文件使用"pdfFactory Pro"试用版本创建蚨à

泰欣生 h-R3 临床试验总结(幻灯)

病例筛查

Screening and inclusion

n

n

n

n详细的病史采集（既往史）和体格检查The detailed medical records of patients was collected, including historical documents, physical examination肿瘤专科检查（间接鼻咽镜和/或纤维鼻咽镜）Oncology specialized examination( indirect nasopharyngeal endoscope or fiberscope examination )鼻咽活检（组织学、受体检测）Nasopharyngeal biopsy (Histology, receptor examination)疗前口腔处理

Oral carvitypretreatments

化验室检查：血常规、血生化

Labouratorytests: blood routine examination, Blood Biochemistry

心电图

Electrocardiogram, ECG

影像学检查：颈部和腹部彩超、胸正侧位片、鼻咽增强CT/MRI(层厚5-7mm）、骨ECT（选）

Consistent imaging examination: neck and abdomen color ultrasonograph, front and side chest X-ray, bond ECT, enhanced CT or MRI at nasopharynx(5~7 mm/layer) , ECT at bone (optional).nnn

泰欣生 h-R3 临床试验总结(幻灯)

TM泰欣生给药方法：

Administration of h-R3

n

n

n250ml生理盐水250 mLof sodium chloride 泰欣生剂量为100mg/次/人The level of h-R3 dose was 100 mg for each infusion each patient 静脉内滴注> 60分钟Time of the intravenous infusions was over 60 min 第一次注射时间为：放疗开始第一天

The first infusion was administered on the first day of RT;

以后：每周注射一次（放疗前1小时），同时行放疗

Followed by 7~8 weekly infusions.

与放疗同步结束

The Administration of h-R3 should be ended simutanouslywith RT.nn

泰欣生 h-R3 临床试验总结(幻灯)

放射治疗

Radiotherapy

n直线加速器6MV-X线照射/All patients received radiation of 6 MV X-ray from a linear accelerator;

照射野的设计：/The planning of irradiation fields was as follows:

n面颈联合野：DT 36Gy/19F/24D，缩野

Face-neck fields : DT 36Gy/19F/24D, Reduced field

n耳前野：34Gy/17F/23D

ear-front fields:34Gy/17F/23D

放疗剂量Doses of Radiotherapy:

鼻咽部：根治剂量：70-76Gy/7-8W

nasopharynx:radical cure dose: 70-76Gy/7-8W

颈部：根治剂量：70Gy /7-8W

Neck: radical cure dose: 70Gy /7-8Wnnnn

泰欣生 h-R3 临床试验总结(幻灯)

随诊Requirements of Follow-upn

放疗中：During the Radiotherapy:每周全面体检、肿瘤专科检查一次(鼻咽镜、颈部淋巴结)并描述及绘并描述及绘图 complete physicial examinations and tumor specialized examinations, including indirect indirect nasopharynx endoscopy or fiberscopy, fiberscopy, should be performed weekly and the observation through endoscope was documented by drawing. n每周至少测血常规一次 Whole blood cell counts should be done at least once a week n每周进行放疗副

反应评价(RTOG标准) The severity of acute adverse reaction of RT should be evaluated according to RTOG criteria. n放疗中(50Gy)行CT/MRI Imaging examinations with enhanced CT or MRI (50Gy)放疗后：After the Radiotherapy:全面体检、肿瘤专科检查(鼻咽镜、颈部淋巴 n疗后第5周结) 5th week after cure complete physicial examinations and n疗后第17周 tumor specialized examinations, 17th week after cure CT/MRI颈部腹部彩超/neck and abdomen colorn

n

ultrasonograph,PDF文件使用"pdfFactory Pro"试用版本创建ÿ

泰欣生 h-R3 临床试验总结(幻灯)

TM泰欣生

II期临床研究结果

Results of Clinical Trial Phase II