ChiCTR2500110359 版本V1.0 版本创建时间2025/10/13 10:26:34 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2500110359 

最近更新日期：

Date of Last Refreshed on：

2025-10-13 10:26:29 

注册时间：

Date of Registration：

2025-10-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

西妥昔单抗β联合替雷利珠单抗和化疗新辅助治疗局部晚期鼻咽癌的前瞻性、单臂、II期临床研究

Public title：

Cetuximab β combined with Tislelizumab and chemotherapy as neoadjuvant therapy for locally advanced nasopharyngeal carcinoma: A prospective, single-arm, Phase II study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

西妥昔单抗β联合替雷利珠单抗和化疗新辅助治疗局部晚期鼻咽癌的前瞻性、单臂、II期临床研究

Scientific title：

Cetuximab β combined with Tislelizumab and chemotherapy as neoadjuvant therapy for locally advanced nasopharyngeal carcinoma: A prospective, single-arm, Phase II 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：

张国义 

研究负责人：

张国义 

Applicant：

Guoyi Zhang 

Study leader：

Guoyi Zhang 

申请注册联系人电话：

Applicant telephone：

+86 180 3886 0111

研究负责人电话：

Study leader's telephone：

+86 180 3886 0111

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：

guoyizhff@163.com

研究负责人电子邮件：

Study leader's E-mail：

guoyizhff@163.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：

广东省佛山市禅城区岭南大道北81号

研究负责人通讯地址：

广东省佛山市禅城区岭南大道北81号

Applicant address：

No. 81, North Lingnan Avenue, Chancheng District, Foshan City, Guangdong Province

Study leader's address：

Foshan First People's Hospital, No. 81, North Lingnan Avenue, Chancheng District, Foshan City, Guangdong 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：

佛山市第一人民医院

Applicant's institution：

The First People's Hospital of Foshan

研究负责人所在单位：

佛山市第一人民医院

Affiliation of the Leader：

The First People's Hospital of Foshan

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

伦审研(2025)第239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：

佛山市第一人民医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the First People's Hospital of Foshan

伦理委员会批准日期：

Date of approved by ethic committee：

2025-08-27 00:00:00

伦理委员会联系人：

邓燕明

Contact Name of the ethic committee：

Yanming Deng

伦理委员会联系地址：

广东省佛山市禅城区岭南大道北81号

Contact Address of the ethic committee：

No. 81, North Lingnan Avenue, Chancheng District, Foshan City, Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 757 8316 3871

伦理委员会联系人邮箱：

Contact email of the ethic committee：

fsllwyh@fsyy.com

研究实施负责（组长）单位：

佛山市第一人民医院

Primary sponsor：

The First People's Hospital of Foshan

研究实施负责（组长）单位地址：

广东省佛山市禅城区岭南大道北81号

Primary sponsor's address：

No. 81, North Lingnan Avenue, Chancheng District, Foshan City, Guangdong 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)：

广东

市(区县)：

佛山

Country：

China

Province：

Guangdong

City：

Foshan

单位(医院)：

佛山市第一人民医院

具体地址：

广东省佛山市禅城区岭南大道北81号

Institution
hospital：

The First People's Hospital of Foshan

Address：

No. 81, North Lingnan Avenue, Chancheng District, Foshan City, Guangdong Province

经费或物资来源：

百济神州（北京）生物科技有限公司 江苏先声再明医药有限公司

Source(s) of funding：

BeiGene (Beijing) Biotechnology Co., Ltd. Jiangsu Xiansheng Zaiming Pharmaceutical Co., Ltd.

Target disease：

nasopharyngeal carcinoma

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：

探索西妥昔单抗β联合PD-1单抗（替雷利珠单抗）和化疗新辅助治疗局部晚期鼻咽癌的有效性及安全性。  

Objectives of Study：

To explore the efficacy and safety of cetuximab β combined with PD-1 monoclonal antibody and chemotherapy(Tislelizumab) as neoadjuvant therapy for locally advanced nasopharyngeal carcinoma.

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. 病理确诊为分化型非角化性癌和未分化型非角化性癌的初治鼻咽癌。 2. 临床分期为II-III期鼻咽癌（排除T3-4N0及仅咽后淋巴结阳性的T3N1患者）（根据第九版AJCC分期标准）(注：病人治疗前应接受鼻咽和颈部的增强磁共振（MRI）检查以进行分期；若病人有MRI检查的禁忌症，增强的计算机断层扫描(CT)检查也可以接受。排除远处转移的检查包括胸部X线照片、肝脏B超和全身骨显像，也可以用增强的CT/MRI或PET/CT）。 3. ECOG 体能状态评分（PS评分）0或1（附录2）。 4. 年龄18-70岁，无严重心、肺、肝、肾等重要器官功能障碍。 5. 入组前未接受过任何鼻咽癌相关的化疗或放疗。 6. 实验室指标：白细胞>3.0×10^9/L、中性粒细胞>1.5×10^9/L、血小板计数>100×10^9/L、血红蛋白>90g/L；血清总胆红素 < 1.5倍正常值上限，ALT或AST < 2.5倍正常值上限；肌酐 <1.5倍正常值上限且肌酐清除率>=60mL/min；凝血参数APTT正常值上限延长不超过10秒，PT正常值上限延长不超过3秒。 7. 有妊娠能力的女性受试者必须同意从筛选访视到末次PD-1单抗给药后1年内使用可靠的避孕措施；女性伴侣有妊娠能力的男性受试者必须同意从筛选访视到末次PD-1单抗给药后1年内使用可靠的避孕措施。 8. 受试者自愿加入本研究，签署知情同意书，依从性好，配合随访。

Inclusion criteria

1. Pathologically confirmed nasopharyngeal carcinoma with differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma. 2. Clinical stage of stage II-III nasopharyngeal carcinoma (excluding T3-4N0 and T3N1 patients with positive retropharyngeal lymph nodes only) (according to the ninth edition of AJCC staging criteria) (Note: Patients should undergo enhanced magnetic resonance (MRI) examination of the nasopharynx and neck for staging before treatment; If the patient has contraindications to MRI, enhanced computed tomography (CT) is also acceptable. Tests to rule out distant metastases include chest x-rays, liver ultrasound, and whole-body bone scintigraphies, and can also be enhanced CT/MRI or PET/CT). 3. ECOG performance status score (PS score) 0 or 1 (Appendix 2). 4. Age 18-70 years old, no serious heart, lung, liver, kidney and other important organ dysfunction. 5. No chemotherapy or radiotherapy related to nasopharyngeal cancer before enrollment. 6. Laboratory indicators: white blood cell > 3.0×10^9/L, neutrophil > 1.5×10^9/L, platelet count >100×10^9/L, hemoglobin >90g/L; Serum total bilirubin < 1.5 times the upper limit of normal value, ALT or AST < 2.5 times the upper limit of normal value; Creatinine < 1.5 times the upper limit of normal value and creatinine clearance >=60mL/min; The upper limit of the normal value of APTT for coagulation parameters was extended by no more than 10 seconds, and the upper limit of normal value of PT was extended by no more than 3 seconds. 7. Female subjects of childbearing potential must agree to use reliable contraception from the screening visit to 1 year after the last dose of PD-1 monoclonal antibody; Male subjects with female partners of childbearing potential must agree to use reliable contraception from the screening visit until 1 year after the last dose of PD-1 monoclonal antibody. 8. Subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.

排除标准：

1. 妊娠（经血或尿HCG检测确认）或哺乳期妇女，或育龄期受试者不愿或不能采取有效的避孕措施（既适用于男性也适用于女性受试者）直到末次试验治疗后至少6个月； 2.既往对本方案中使用的大分子蛋白制剂，或西妥昔单抗β、替雷利珠单抗任何成分有过敏史者； 3.有临床症状的中枢神经系统转移伴脑水肿、需要激素干预，或脑转移进展； 4.既往5年内或同时有其它恶性肿瘤病史，但已治愈的皮肤基底细胞癌和宫颈原位癌以及甲状腺乳头癌等除外； 5.接受过以下的任何治疗： （1）. 4周内接受过PD-1\PD-L1抑制剂、CTLA-4抗体、EGFR单抗、EGFR-TKI、抗血管生成药物治疗； （2）.首次使用研究药物前4周内接受过任何研究性药物实验； （3）.同时入组另外一项临床研究，除非是观察性（非干预性）临床研究或者干预性临床研究随访； （4）.在签署知情同意书前28天内接受了等效剂量＞10mg强的松/天的全身性激素或者其他免疫抑制治疗，全身性激素剂量<=10mg强的松/天或吸入/外用皮质类固醇的受试者可以入选； （5）.接种过抗肿瘤疫苗或者研究药物首次给药前4周内曾接种过活疫苗； （6）.首次使用研究药物前4周内接受过大手术或者严重外伤。 6.未能控制的心脏临床症状或疾病，如：（1）NYHAⅡ级以上心力衰竭（2）不稳定型心绞痛（3）1年内发生过心肌梗死（4）有临床意义上的室上性或者室性心律失常需要临床干预的患者； 7.首次使用研究药物前4周内发生过严重感染（CTC AE大于2级），如需要住院的严重肺炎、菌血症、感染合并症等；基线胸部影像学检查提示存在活动性肺部炎症、首次使用研究药物前2周内存在感染的症状和体征或需要口服或静脉使用·抗生素治疗（不包括预防性使用抗生素的情况）； 8.有间质性肺病病史和非感染性肺炎病史； 9.通过病史或者CT检查发现有活动性肺结核感染，或入组前1年内有活动性肺结核感染病史的患者，或查过1年以前有活动性肺结核感染病史但未经正规治疗患者； 10.有活动性的自身免疫性疾病、自身免疫性疾病史（如间质性肺炎、结肠炎、肝炎、垂体炎、血管炎、肾炎、甲状腺功能亢进症、甲状腺功能减退症，包括但不限于这些疾病和综合症）；使用稳定剂量的甲状腺替代激素治疗的自身免疫介导的甲状腺功能减退症；使用稳定剂量的胰岛素I型糖尿病；但不包括白癜风或已痊愈的童年时代哮喘/过敏，成人后无需任何干预的患者； 11.有免疫缺陷病史，包括HIV检测阳性，或患有其他获得性、先天性免疫缺陷疾病，或有器官移植史和骨髓移植史； 12.受试者存在活动性肝炎HBsAg阳性且HBV DNA>=2000IU/ml 或者1000 copies/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）； 13.已知有精神类药物的滥用、酗酒及吸毒史； 14.研究者认为不适合纳入者。

Exclusion criteria：

1. Pregnant (confirmed by menstrual blood or urine HCG test) or lactating women, or subjects of childbearing age are unwilling or unable to take effective contraceptive measures (both for male and female subjects) until at least 6 months after the last trial treatment; 2. Those who have a history of allergy to the macromolecular protein preparations used in this regimen or any component of cetuximab β tislelizumab; 3. Central nervous system metastases with cerebral edema, requiring hormone intervention, or progression of brain metastases; 4. History of other malignant tumors within or at the same time within the past 5 years, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid cancer; 5. Has received any of the following treatments: (1). Received PD-1\PD-L1 inhibitors, CTLA-4 antibodies, EGFR monoclonal antibodies, EGFR-TKIs, and anti-angiogenic drugs within 4 weeks; (2). Received any investigational drug experiment within 4 weeks before the first use of the study drug; (3). Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; (4). Subjects who have received systemic hormones or other immunosuppressive therapy at an equivalent dose >10mgprednisone/day or other immunosuppressive therapy within 28 days before signing the informed consent form, and subjects with systemic hormone doses <=10mgprednisone/day or inhaled/topical corticosteroids can be enrolled; (5). Received anti-tumor vaccine or live vaccine within 4 weeks before the first dose of study drug; (6). Major surgery or severe trauma within 4 weeks before the first use of the study drug. 6. Uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 7. Serious infection (CTC AE greater than grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection comorbidities, etc. requiring hospitalization; Baseline chest imaging suggests active pulmonary inflammation, symptoms and signs of infection within 2 weeks prior to the first use of study drug, or need for oral or intravenous antibiotic treatment (excluding prophylactic antibiotic use); 8. History of interstitial lung disease and non-infectious pneumonitis; 9. Patients with active tuberculosis infection found through medical history or CT examination, or a history of active tuberculosis infection within 1 year before enrollment, or patients with a history of active tuberculosis infection 1 year ago but without formal treatment; 10. Active autoimmune disease, history of autoimmune disease (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); Autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone; Diabetes mellitus using a stable dose of insulin; However, it does not include patients with vitiligo or cured childhood asthma/allergies who do not require any intervention after adulthood; 11. History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and bone marrow transplantation; 12. Subjects with active hepatitis HBsAg positive and HBV DNA>=2000IU/ml or 1000 copies/ml, hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method); 13. Known history of psychotropic drug abuse, alcohol abuse and drug abuse; 14. Those who are not suitable for inclusion in the opinion of the investigator.

研究实施时间：

Study execute time：

从 From 2025-10-22 00:00:00至 To 2028-09-22 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-10-22 00:00:00 至 To 2027-09-22 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

33

Group：

Treatment group

Sample size：

干预措施：

西妥昔单抗β联合替雷利珠单抗及化疗

干预措施代码：

Intervention：

Cetuximab β combined with Tislelizumab and chemotherapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

 佛山 

Country：

China 

Province：

Guangdong 

City：

Foshan 

单位(医院)：

佛山市第一人民医院 

单位级别：

三级甲等 

Institution
hospital：

The First People's Hospital of Foshan

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

新辅助治疗后的完全缓解率

指标类型：

主要指标

Outcome：

Complete Response Rate, CR

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：

Objective Response Rate,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：

3年无远处转移率

指标类型：

次要指标

Outcome：

3-year 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：

3年无局部区域复发生存率

指标类型：

次要指标

Outcome：

3-year Locoregional Relapse-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：

3年无进展生存率

指标类型：

次要指标

Outcome：

3-year Progression-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：

3年总生存率

指标类型：

次要指标

Outcome：

3-year 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：

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：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

血液

Sample Name：

Blood

Tissue：

Blood

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：

肿瘤组织

组织：

鼻咽

Sample Name：

Tumor tissue

Tissue：

nasopharynx

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 18 岁 years
最大 Max age 70 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）：

本研究为单臂研究，不设置对照组。

Randomization Procedure (please state who generates the random number sequence and by what method)：

This study was a single-arm study and no control group was set up.

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）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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）：

不共享

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：

数据的录入：任何录入病历报告表中的资料必须与原始病历记录相符合。通过伦理审批后，经过信息科的批准，数据收集由研究助理或科研护士通过门诊或住院检查，邮件联系，电话联系，电子邮件联系，或通过其他网络联系方式获取随访数据。随访数据可由患者本人提供，无法获得时也可由患者亲属提供。研究中心将填写患者记录表，指出适合入选的所有患者和患者的登记状态，在患者记录表上不能收集患者个人真实姓名、身份证等识别符。原始数据文件中的所有数据将在病例报告表中进行汇总，或转录病例报告表中。所有私人识别数据将进行匿名化，确保患者的个人信息不被泄露。数据核查和管理的内容和方式：研究者根据研究方案将收集的数据填入病历报告表患者管理系统。研究者在记录及收集数据应做到整洁、清晰、完整，以确保数据解释的准确性。加强质量控制，包括收集数据和原始文件的准确性和易读性、源数据验证的程度和终点的确认，记录并存档为生成结果而进行的统计编程。数据核查和管理的内容和方式：研究者根据研究方案将收集的数据填入病历报告表患者管理系统。研究者在记录及收集数据应做到整洁、清晰、完整，以确保数据解释的准确性。加强质量控制，包括收集数据和原始文件的准确性和易读性、源数据验证的程度和终点的确认，记录并存档为生成结果而进行的统计编程。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Entry of data: Any information entered in a medical record report form must be consistent with the original medical record record. Following ethical approval and with the approval of the Information Section, data collection is carried out by research assistants or research nurses to obtain follow-up data through outpatient or inpatient check-ups, mail contact, telephone contact, email contact, or other online contact methods. Follow-up data can be provided by the patient himself, or by relatives of the patient when it is not available. The research center will fill out a patient records form indicating all patients suitable for inclusion and the registration status of patients. On the patient records, patients' personal real names, identity cards and other identifiers cannot be collected. All data in the original data file will be summarized in the case report form, or transcribed in the case report form. All privately identifiable data will be anonymized to ensure that patients' personal information is not compromised. Contents and modalities of data verification and management: The researchers entered the data collected into the patient management system of the medical records report form according to the research programme. Researchers should record and collect data in a clean, clear and complete manner to ensure the accuracy of data interpretation. Enhanced quality control, including accuracy and legibility of collected data and source documents, extent of source data validation and validation of endpoints, and documentation and documentation of statistical programming to generate results. Contents and modalities of data verification and management: The researchers entered the data collected into the patient management system of the medical records report form according to the research programme. Researchers should record and collect data in a clean, clear and complete manner to ensure the accuracy of data interpretation. Enhanced quality control, including accuracy and legibility of collected data and source documents, extent of source data validation and validation of endpoints, and documentation and documentation of statistical programming to generate results.

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：

  2025-10-13 10:26:29