注册号:
Registration number:
ChiCTR2600121720 最近更新日期:
Date of Last Refreshed on:
2026-04-02 08:28:34 注册时间:
Date of Registration:
2026-04-02 00:00:00 注册号状态:
预注册Registration Status:
Prospective registration注册题目:
诱导化免后放疗同步尼妥珠单抗治疗老年(>60岁)局部晚期鼻咽癌患者:单臂、II期临床研究Public title:
Induction Chemoimmunotherapy Followed by Concurrent Radiotherapy and Nimotuzumab in Elderly Patients (>60 Years) with Locally Advanced Nasopharyngeal Carcinoma: A Single-Arm, Phase II Clinical Study注册题目简写:English Acronym:研究课题的正式科学名称:
诱导化免后放疗同步尼妥珠单抗治疗老年(>60岁)局部晚期鼻咽癌患者:单臂、II期临床研究Scientific title:
Induction Chemoimmunotherapy Followed by Concurrent Radiotherapy and Nimotuzumab in Elderly Patients (>60 Years) with Locally Advanced Nasopharyngeal Carcinoma: A Single-Arm, Phase II Clinical Study研究课题代号(代码):
Study subject ID:在二级注册机构或其它机构的注册号:
The registration number of the Partner Registry or other
register:申请注册联系人:
陈佳
研究负责人:
陈佳 Applicant:
Jia Chen
Study leader:
Jia Chen 申请注册联系人电话:
Applicant telephone:
+86 152 7438 8471
研究负责人电话:
Study leader's telephone:
+86 152 7438 8471申请注册联系人传真 :
Applicant Fax:
研究负责人传真:
Study leader's fax:申请注册联系人电子邮件:
Applicant E-mail:
1010836606@qq.com
研究负责人电子邮件:
Study leader's E-mail:
1010836606@qq.com申请单位网址(自愿提供):
Applicant website(voluntary supply):
研究负责人网址(自愿提供):
Study leader's website(voluntary supply):申请注册联系人通讯地址:
中国湖南省吉首市乾州新区世纪大道与建新路交汇处
研究负责人通讯地址:
中国湖南省吉首市乾州新区世纪大道与建新路交汇处Applicant address:
Intersection of Century Avenue and Jianxin Road, Qianzhou New District, Jishou, Hunan, China
Study leader's address:
Intersection of Century Avenue and Jianxin Road, Qianzhou New District, Jishou, Hunan, China申请注册联系人邮政编码:
Applicant postcode:
研究负责人邮政编码:
Study leader's postcode:申请人所在单位:
湘西土家族苗族自治州人民医院Applicant's institution:
The People's Hospital of Xiangxi Tujia and Miao Autonomous Prefecture研究负责人所在单位:
湘西土家族苗族自治州人民医院Affiliation of the Leader:
The People's Hospital of Xiangxi Tujia and Miao Autonomous Prefecture是否获伦理委员会批准:
是Approved by ethic committee:
Yes伦理委员会批件文号:
Approved No. of ethic committee:
EC-LCKY2026053-1
伦理委员会批件附件:
Approved file of Ethical Committee:
查看附件View批准本研究的伦理委员会名称:
湘西土家族苗族自治州人民医院医学伦理委员会Name of the ethic committee:
The Medical Ethics Committee of The People's Hospital of Xiangxi Tujia and Miao Autonomous Prefecture伦理委员会批准日期:
Date of approved by ethic committee:
2026-04-01 00:00:00伦理委员会联系人:
范自力Contact Name of the ethic committee:
Zili Fan伦理委员会联系地址:
中国湖南省吉首市乾州新区世纪大道与建新路交汇处Contact Address of the ethic committee:
Intersection of Century Avenue and Jianxin Road, Qianzhou New District, Jishou, Hunan, China伦理委员会联系人电话:
Contact phone of the ethic committee:
+86 189 7518 6088
伦理委员会联系人邮箱:
Contact email of the ethic committee:研究实施负责(组长)单位:
湘西土家族苗族自治州人民医院Primary sponsor:
The People's Hospital of Xiangxi Tujia and Miao Autonomous Prefecture研究实施负责(组长)单位地址:
中国湖南省吉首市乾州新区世纪大道与建新路交汇处Primary sponsor's address:
Intersection of Century Avenue and Jianxin Road, Qianzhou New District, Jishou, Hunan, China试验主办单位(项目批准或申办者):
Secondary sponsor:
国家:
中国
省(直辖市):
湖南
市(区县):
Country:
China
Province:
Hunan
City:
单位(医院):
湘西土家族苗族自治州人民医院
具体地址:
中国湖南省吉首市乾州新区世纪大道与建新路交汇处
Institution
hospital:
The People's Hospital of Xiangxi Tujia and Miao Autonomous Prefecture
Address:
Intersection of Century Avenue and Jianxin Road, Qianzhou New District, Jishou, Hunan, China经费或物资来源:
信达生物制药(苏州)有限公司Source(s) of funding:
Innovent Biologics (Suzhou) Co., Ltd.研究疾病:
鼻咽癌 Target disease:
Nasopharyngeal Carcinoma研究疾病代码:Target disease code:研究类型:
干预性研究Study type:
Interventional study研究所处阶段:
II期临床试验 Study phase:
2研究设计:
单臂 Study design:
Single arm 研究目的:
探索免疫联合化疗诱导+放疗同步尼妥珠单抗+免疫辅助治疗模式在>60岁局部晚期鼻咽癌治疗中的疗效性和安全性。 Objectives of Study:
Exploring the Efficacy and Safety of Immunotherapy Combined with Chemotherapy Induction + Radiotherapy Concurrent with Nimotuzumab + Immunotherapy Adjuvant Treatment Model in Locally Advanced Nasopharyngeal Carcinoma Patients Aged > 60 Years药物成份或治疗方案详述:
Description for medicine or protocol of treatment in
detail:
纳入标准:
1.签署知情同意书;
2.年龄>60周岁;
3.经病理确诊的初治鼻咽癌(WHO 病理分型 II 型或 III 型);
4.AJCC 第八版分期为 T1-4N2-3/T4N1;
5.KPS 评分>=70 分;
6.无严重的造血功能异常和心、肺、肝、肾功能异常和免疫缺陷;
7.甲状腺、肾上腺、垂体功能正常。Inclusion criteria
1. Signed informed consent form;
2. Age > 60 years;
3. Pathologically confirmed newly diagnosed nasopharyngeal carcinoma (WHO pathological type II or III);
4.AJCC 8th edition stage T1-4N2-3/T4N1;
5. Karnofsky Performance Status (KPS) score >= 70;
6.No severe hematopoietic dysfunction, cardiac, pulmonary, hepatic, renal dysfunction, or immunodeficiency;
7.Normal thyroid, adrenal, and pituitary function.排除标准:
1.同时存在的其它全身性糖皮质激素/免疫抑制剂治疗;
2.患者存在活动性自身免疫病/人免疫缺陷病毒(HIV)/需要全身治疗的活动性感染;
3.接受活疫苗接种<30天
4.既往或同时第二原发恶性肿瘤(非恶性黑色素瘤的皮肤癌、甲状腺癌、宫颈原位癌、 对侧非浸润性乳腺癌除外);
5.严重合并症(如终末期疾病)。Exclusion criteria:
1. Concurrent treatment with other systemic glucocorticoids/immunosuppressants;
2.Presence of active autoimmune disease, human immunodeficiency virus (HIV) infection, or active infection requiring systemic treatment;
3.Receipt of live vaccine within < 30 days;
4. History of or concurrent second primary malignancy (excluding non-melanoma skin cancer, thyroid cancer, cervical carcinoma in situ, and contralateral non-invasive breast cancer);
5. Severe comorbidities (e.g., end-stage disease).研究实施时间:
Study execute time:
从
From
2026-04-06 00:00:00至
To
2031-04-06 00:00:00
征募观察对象时间:
Recruiting time:
从
From
2026-04-06 00:00:00
至
To
2027-10-06 00:00:00干预措施:
Interventions:
组别:
试验组
样本量:
36
Group:
Experimental group
Sample size:
干预措施:
1.诱导化疗联合免疫治疗:信 迪 利 单 抗 200mg ivgtt d0+ 吉 西 他 滨 1000mg/m^2 ivgtt d1,8+ 顺 铂25mg/m^2 ivgtt d1-3,Q3W,共 3 周期。
2.放疗同步尼妥珠单抗:
(a)放疗方案:采用容积旋转调强放射治疗技术(VMAT)。具体处方剂量为95%PGTVnx69.96Gy/2.12Gy/33f,95%PGTVnd69.96Gy/2.12Gy/33f,
95%PGTVrpn69.96Gy/2.12Gy/33f ,95%PTV1 60.06Gy/1.82Gy/33f,95%PTV2 50.4Gy/1.8Gy/28f。
(b)尼妥珠单抗:200 mg 每周1次 共6次。
3.维持:信迪利单抗 200mg ivgtt d1 q3w 共 9 周期。
干预措施代码:
Intervention:
1.Induction chemotherapy combined with immunotherapy:Sintilimab 200 mg intravenous infusion (ivgtt) on day 0, plus Gemcitabine 1000 mg/m^2 intravenous infusion (ivgtt) on days 1 and 8, plus Cisplatin 25 mg/m^2 intravenous infusion (ivgtt) on days 1–3, administered every 3 weeks (Q3W) for a total of 3 cycles.
(2) Radiotherapy concurrent with Nimotuzumab:
(a) Radiotherapy regimen: Volumetric Modulated Arc Therapy (VMAT) was employed. The prescribed doses were as follows:
95% PGTVnx: 69.96 Gy / 2.12 Gy per fraction / 33 fractions;
95% PGTVnd: 69.96 Gy / 2.12 Gy per fraction / 33 fractions;
95% PGTVrpn: 69.96 Gy / 2.12 Gy per fraction / 33 fractions;
95% PTV1: 60.06 Gy / 1.82 Gy per fraction / 33 fractions;
95% PTV2: 50.4 Gy / 1.8 Gy per fraction / 28 fractions.
(b) Nimotuzumab: 200 mg once weekly for a total of 6 doses.
(3) Maintenance immunotherapy:Sintilimab 200 mg intravenous infusion (ivgtt) on day 1, every 3 weeks (q3w) for a total of 9 cycles.
Intervention code:研究实施地点:
Countries of recruitment and research settings:
国家:
中国
省(直辖市):
湖南
市(区县):
Country:
China
Province:
Hunan
City:
单位(医院):
湘西土家族苗族自治州人民医院
单位级别:
三甲
Institution
hospital:
The People's Hospital of Xiangxi Tujia and Miao Autonomous Prefecture
Level of the institution:
Tertiary A测量指标:
Outcomes:
指标中文名:
3 年无事件生存
指标类型:
主要指标
Outcome:
3-year Event Free Survival
Type:
Primary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
总生存
指标类型:
次要指标
Outcome:
Overall Survival
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
无事件生存
指标类型:
次要指标
Outcome:
Event Free Survival
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
局部无复发生存
指标类型:
次要指标
Outcome:
Local Recurrence-Free Survival
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
无远处转移生存
指标类型:
次要指标
Outcome:
Distant Metastasis-Free Survival
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
临床完全缓解率
指标类型:
次要指标
Outcome:
Clinical Complete Response Rate
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
部分缓解率
指标类型:
次要指标
Outcome:
Partial Response Rate
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
客观缓解率
指标类型:
次要指标
Outcome:
Objective Response Rate
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
依从性
指标类型:
次要指标
Outcome:
Compliance
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
生活质量
指标类型:
次要指标
Outcome:
Quality of Life
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:
指标中文名:
安全性
指标类型:
次要指标
Outcome:
Safety
Type:
Secondary indicator
测量时间点:
测量方法:
Measure time point of outcome:
Measure method:采集人体标本:
Collecting sample(s)
from participants:
标本中文名:
血液
组织:
Sample Name:
Blood
Tissue:
人体标本去向
使用后销毁
说明
Fate of sample:
Destruction after use
Note:征募研究对象情况:
Recruiting status:
尚未开始
Not yet
recruiting
年龄范围:
Participant age:
最小
Min age
60
岁
years
最大
Max age
岁
years性别:
男女均可
Gender:
Both随机方法(请说明由何人用什么方法产生随机序列):
无Randomization Procedure (please state who
generates the
random number sequence and by what method):
None是否公开试验完成后的统计结果:
Calculated Results after the Study Completed public access:
公开/Public盲法:Blinding:试验完成后的统计结果(上传文件):
点击下载Calculated Results after
the Study Completed(upload file):
download是否共享原始数据:
IPD sharing
否No共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):
无The way of sharing IPD”(include metadata and
protocol,
If use web-based public database, please provide
the
url):
None数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case
Record Form, CRF),二为电子采集和管理系统(Electronic Data
Capture, EDC),如ResMan即为一种基于互联网的EDC:
数据采集使用病例记录表,管理由我单位电子采集系统管理Data collection and Management (A
standard data collection and management system
include a CRF and an electronic data capture:
Data were collected using case report forms, and the data management was conducted via the electronic data capture system of our institution数据与安全监察委员会:
Data and Safety Monitoring Committee:
暂未确定/Not yet注册人:
Name of Registration:
2026-04-02 08:28:28