中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500103027
最近更新日期： Date of Last Refreshed on：	2025-05-23 08:39:32
注册时间： Date of Registration：	2025-05-23 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	基于新辅助化免治疗后病理学缓解情况分层治疗初始可切除局部晚期头颈部鳞癌的前瞻性II期研究
Public title：	A prospective phase II study of stratified treatment of initially resectable locally advanced HNSCC based on pathological response after neoadjuvant chemo-immunotherapy
注册题目简写：
English Acronym：
研究课题的正式科学名称：	基于新辅助化免治疗后病理学缓解情况分层治疗初始可切除局部晚期头颈部鳞癌的前瞻性II期研究
Scientific title：	A prospective phase II study of stratified treatment of initially resectable locally advanced HNSCC based on pathological response after neoadjuvant chemo-immunotherapy
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：	赵晨	研究负责人：	王琰
Applicant：	Chen Zhao	Study leader：	Yan Wang
申请注册联系人电话： Applicant telephone：	+86 183 1095 1950	研究负责人电话： Study leader's telephone：	+86 139 9885 6576
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：	zhaochen_cmu@163.com	研究负责人电子邮件： Study leader's E-mail：	wangyanoto@aliyun.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：	中国医科大学附属第一医院	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：	辽宁省沈阳市和平区南京北街155号	研究负责人通讯地址：	辽宁省沈阳市和平区南京北街155号
Applicant address：	155 Nanjing North Street, Heping District, Shenyang City, Liaoning Province	Study leader's address：	155 Nanjing North Street, Heping District, Shenyang City, Liaoning Province
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：	中国医科大学附属第一医院
Applicant's institution：	The First Affiliated Hospital of China Medical University
研究负责人所在单位：	中国医科大学附属第一医院
Affiliation of the Leader：	The First Affiliated Hospital of China Medical University

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：	科伦审[2025]2024-1173-2号	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：	中国医科大学附属第一医院医学科学研究伦理委员会
Name of the ethic committee：	Medical Science Research Ethics Committee of the First Affiliated Hospital of China Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2025-01-22 00:00:00
伦理委员会联系人：	赵老师
Contact Name of the ethic committee：	Mr. Zhao
伦理委员会联系地址：	辽宁省沈阳市和平区南京北街155号
Contact Address of the ethic committee：	155 Nanjing North Street, Heping District, Shenyang City, Liaoning Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 24 8328 2837	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：

中国医科大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of China Medical University

研究实施负责（组长）单位地址：

辽宁省沈阳市和平区南京北街155号

Primary sponsor's address：

155 Nanjing North Street, Heping District, Shenyang City, Liaoning Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	辽宁	市(区县)：
Country：	China	Province：	Liaoning	City：
单位(医院)：	中国医科大学附属第一医院	具体地址：	辽宁省沈阳市和平区南京北街155号
Institution hospital：	The First Affiliated Hospital of China Medical University	Address：	155 Nanjing North Street, Heping District, Shenyang City, Liaoning Province

经费或物资来源：

中国医科大学附属第一医院

Source(s) of funding：

The First Affiliated Hospital of China Medical University

研究疾病：

头颈部鳞癌

Target disease：

Head and neck squamous cell 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：

旨在探索替雷利珠单抗联合顺铂及白蛋白紫杉醇新辅助治疗局部晚期头颈部鳞癌并基于新辅助治疗后的病理学缓解情况进行序贯分层治疗的疗效和安全性。

Objectives of Study：

This study aims to explore the efficacy and safety of tislelizumab combined with cisplatin and nab-paclitaxel in the neoadjuvant treatment of locally advanced head and neck squamous cell carcinoma and sequential stratified treatment based on pathological response after neoadjuvant treatment.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Age >= 18 years old;
2. Patients with head and neck malignancies diagnosed with squamous cell carcinoma by pathology;
3. Initially resectable stage III-IVb oral cancer/hypopharyngeal cancer/laryngeal cancer/p16- oropharyngeal cancer, or stage II-III p16+ oropharyngeal cancer (AJCC 8th), and planned to undergo surgical resection;
4. Planned neoadjuvant therapy;
5. No previous anti-tumor treatment for HNSCC;
6. Eastern Cooperative Oncology Group Performance Status (ECOG) score 0-1;
7. Expected survival >= 3 months
8. The function of important organs meets the following requirements (excluding the use of any blood components and cell growth factors within 7 days): Normal bone marrow reserve function, white blood cells (WBC)>= 3.0×10^9/L; neutrophil count (NEUT) >=1.5×10^9/L, platelet count (PLT) >=100×10^9/L, hemoglobin (Hb) >=90 g/L; Normal renal function or serum creatinine (SCr) <= 1.5 times the upper limit of normal (ULN) or creatinine clearance >=50 ml/min (Cockcroft-Gault formula); Normal liver function or total bilirubin (TBIL) <= 1.5 times the upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level <= 2.5 times the upper limit of normal (ULN);
9. Able and willing to comply with the study and follow-up procedures;
10. Males and females of childbearing age must agree to take adequate contraceptive measures throughout the study and within 6 months after the end of treatment;
11. Patients voluntarily join this clinical study and sign the informed consent form, with good compliance and able to cooperate with follow-up.

排除标准：

1. 既往接受过抗 PD-1 抗体、抗 PD-L1 抗体、抗 PD-L2 抗体或抗CTLA-4 抗体（或作用于 T 细胞协同刺激或检查点通路的任何其他抗体）； 2. 原发灶分期为T4b的患者； 3. 有明确过敏史，可能对研究药物及其类似生物制剂潜在过敏或不耐受； 4. 首次给药前4周内参加过其他抗肿瘤药物临床试验；或首次给药前4周内或计划在研究期间接受减毒活疫苗； 5. 5年内发生过其他恶性肿瘤（经过充分治疗的皮肤鳞癌或已控制的皮肤基底细胞癌除外）； 6. 首次使用替雷利珠单抗前14天之内使用过免疫抑制药物，不包括喷鼻和吸入性皮质类固醇或生理剂量的系统性类固醇激素（即不超过10 mg/天强的松龙或同等药物生理学剂量的其他皮质类固醇） 7. 具有症状的、已播散到内脏的、短期内有出现危及生命的并发症风险的晚期患者（包括有无法控制的大量渗出液[胸腔、心包、腹腔]、肺淋巴管炎及30%以上肝脏受累的患者） 8. 存在任何活动性自身免疫病或有自身免疫病病史（包括但不局限于：自身免疫性肝炎、间质性肺炎，葡萄膜炎、肠炎、肝炎、垂体炎、血管炎、肾炎、甲状腺功能亢进、甲状腺功能降低；受试者患有白癜风或在童年期哮喘已完全缓解，成人后无需任何干预的可纳入；受试者需要支气管扩张剂进行医学干预的哮喘则不能纳入） 9. 患有Ⅱ级以上心肌缺血或心肌梗塞、控制不良的心律失常（包括 QTc间期男性≥450ms、女性≥470ms）。按NYHA标准，Ⅲ～Ⅳ级心功能不全，或心脏彩超检查提示左室射血分数（LVEF）＜50%者；入组前6个月内发生过心肌梗死，纽约心脏学会II级或以上心力衰竭，未得到控制的心绞痛，未得到控制的严重室性心律失常，有临床意义的心包疾病，或者心电图提示急性缺血或活动性传导系统异常 10. 首次用药前4周内并发重度感染（如：需要静脉滴注抗生素、抗真菌或抗病毒药物），或在筛选期间/首次给药前出现不明原因的发热>38.5°C； 11. 具有精神类药物滥用史且无法戒除者或有精神障碍的； 12. 首次给药前4周内接受过重大外科手术。或具有开放性伤口或者骨折； 13. 人类免疫缺陷病毒（HIV）感染或已知有获得性免疫缺陷综合征（艾滋病），活动性乙型肝炎（HBV DNA ≥ 500 IU/ml），丙型肝炎（丙肝抗体阳性，且 HCV-RNA 高于分析方法的检测下限）或合并乙肝和丙肝共同感染； 14. 存在中枢神经系统转移； 15. 患有遗传性或获得性出血病史或凝血功能障碍者（具体由研究者判断能否入选）； 16. 研究者判定不适合参与本研究的其他情况。

Exclusion criteria：

1. Patients who have received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway) in the past; 2. Patients with primary lesion stage T4b; 3. Patients with a clear history of allergies and potential allergies or intolerance to the study drug and its similar biological agents; 4. Patients who have participated in other anti-tumor drug clinical trials within 4 weeks before the first dose; or patients who have received attenuated live vaccines within 4 weeks before the first dose or planned to receive them during the study; 5. Patients who have developed other malignancies within 5 years (except for adequately treated squamous cell carcinoma of the skin or controlled basal cell carcinoma of the skin); 6. Patients who have used immunosuppressive drugs within 14 days before the first use of tislelizumab, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e. no more than 10 mg/day of prednisolone or other corticosteroids of equivalent physiological doses) 7. Advanced patients with symptoms, dissemination to internal organs, and risk of life-threatening complications in the short term (including patients with uncontrolled large amounts of exudate [thoracic, pericardial, abdominal], pulmonary lymphangitis, and more than 30% liver involvement) 8. Any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or complete asthma relief in childhood and no need for any intervention as adults can be included; subjects with asthma that requires medical intervention with bronchodilators cannot be included) 9. Patients with grade II or above myocardial ischemia or myocardial infarction, and poorly controlled arrhythmias (including QTc interval ≥450ms for men and ≥470ms for women). According to NYHA standards, patients with grade III-IV heart failure, or left ventricular ejection fraction (LVEF) <50% on cardiac ultrasound examination; patients with myocardial infarction within 6 months before enrollment, New York Heart Association grade II or higher heart failure, uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmias, clinically significant pericardial disease, or electrocardiogram indicating acute ischemia or abnormal active conduction system 10. Patients with severe infection within 4 weeks before the first medication (such as requiring intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever >38.5°C during the screening period/before the first medication; 11. Patients with a history of psychotropic drug abuse and unable to quit or with mental disorders; 12. Patients with major surgical operations within 4 weeks before the first medication. or with open wounds or fractures; 13. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method) or co-infection with hepatitis B and hepatitis C; 14. Central nervous system metastasis; 15. Patients with a history of hereditary or acquired bleeding or coagulation disorders (the specific selection is determined by the researchers); 16. Other situations determined by the researchers to be unsuitable for participation in this study.

研究实施时间：

Study execute time：

从 From 2025-04-07 00:00:00至 To 2028-03-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-04-29 00:00:00 至 To 2026-03-30 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	30
Group：	Experimental group	Sample size：	30
干预措施：	新辅助治疗阶段接受替雷利珠单抗化疗共给药2-3个周期；术后达到MPR的患者接受替雷利珠单抗治疗；未达到MPR的患者接受标准辅助放疗联合尼妥珠单抗治疗后，序贯替雷利珠单抗治疗	干预措施代码：
Intervention：	Patientsreceived tislelizumab chemotherapy for 2-3 cycles for neoadjuvant treatment . Patients who achieved MPR after surgery received tislelizumab; patients who did not achieve MPR received standard adjuvant radiotherapy combined with nimotuzumab, followed by tislelizumab.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	辽宁	市(区县)：
Country：	China	Province：	Liaoning	City：
单位(医院)：	中国医科大学附属第一医院	单位级别：	三甲
Institution hospital：	The First Affiliated Hospital of China Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	2年无事件生存率	指标类型：	主要指标
Outcome：	2y-EFS rate	Type：	Primary 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：	ORR	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	病理完全缓解率	指标类型：	次要指标
Outcome：	pCR rate	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：	肿瘤组织	组织：
Sample Name：	Tumor tissue	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

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：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	18	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:

不公开/Private

盲法：
Blinding：

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）：	ResMan,论文发表后一年内， http://www.medresman.org.cn/login.aspx。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	ResMan, within one year of publication, http://www.medresman.org.cn/login.aspx.
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：	病例记录表
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case Record Form, CRF
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：	2025-05-23 08:39:22