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：	ChiCTR2600117056
最近更新日期： Date of Last Refreshed on：	2026-01-19 16:08:18
注册时间： Date of Registration：	2026-01-19 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	特瑞普利单抗联合TP方案新辅助治疗局部晚期头颈部肿瘤的单臂前瞻有效性临床研究
Public title：	A Single-Arm Prospective Clinical Study on the Efficacy of Neoadjuvant Therapy with Toripalimab Combined with TP Regimen for Locally Advanced Head and Neck Tumors
注册题目简写：
English Acronym：
研究课题的正式科学名称：	特瑞普利单抗联合TP方案新辅助治疗局部晚期头颈部肿瘤的单臂前瞻有效性临床研究
Scientific title：	A Single-Arm Prospective Clinical Study on the Efficacy of Neoadjuvant Therapy with Toripalimab Combined with TP Regimen for Locally Advanced Head and Neck Tumors
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：	曾蓉	研究负责人：	曾蓉
Applicant：	Zeng Rong	Study leader：	Zeng Rong
申请注册联系人电话： Applicant telephone：	+86 152 8848 6986	研究负责人电话： Study leader's telephone：	+86 88486986
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：	rongzi2005146@163.com	研究负责人电子邮件： Study leader's E-mail：	rongzi2005146@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：	云南省昆明市西山区金碧路157号	研究负责人通讯地址：	云南省昆明市西山区金碧路157号
Applicant address：	No. 157 Jinbi Road, Xishan District, Kunming City, Yunnan Province, China	Study leader's address：	No. 157 Jinbi Road, Xishan District, Kunming City, Yunnan Province, 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：	云南省第一人民医院
Applicant's institution：	The First People's Hospital of Yunnan Province
研究负责人所在单位：	云南省第一人民医院
Affiliation of the Leader：	The First People's Hospital of Yunnan Province

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：	KHLL2025-KY196	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：	云南省第一人民医院临床研究伦理委员会
Name of the ethic committee：	Clinical Research Ethics Committee of The First People's Hospital of Yunnan Province
伦理委员会批准日期： Date of approved by ethic committee：	2025-07-08 00:00:00
伦理委员会联系人：	李爱琳
Contact Name of the ethic committee：	Li Ailin
伦理委员会联系地址：	云南省昆明市西山区金碧路157号
Contact Address of the ethic committee：	No. 157 Jinbi Road, Xishan District, Kunming City, Yunnan Province, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 884 830 2717	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：

云南省第一人民医院

Primary sponsor：

The First People's Hospital of Yunnan Province

研究实施负责（组长）单位地址：

云南省昆明市西山区金碧路157号

Primary sponsor's address：

No. 157 Jinbi Road, Xishan District, Kunming City, Yunnan Province, 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)：	云南省	市(区县)：	昆明市
Country：	China	Province：	Yunnan Province	City：	Kunming City
单位(医院)：	云南省第一人民医院	具体地址：	云南省昆明市西山区金碧路157号
Institution hospital：	The First People's Hospital of Yunnan Province	Address：	No. 157 Jinbi Road, Xishan District, Kunming City, Yunnan Province, China

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

头颈部鳞状细胞癌

Target disease：

Head and Neck Squamous Cell Carcinoma (HNSCC)

研究疾病代码：

H1625

Target disease code：

H1625

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

单臂

Study design：

Single arm

研究目的：

评价特瑞普利单抗或联合TP方案（白蛋白紫杉醇，顺铂）新辅助治疗局部晚期头颈部鳞癌患者的疗效及安全性。

Objectives of Study：

Evaluate the efficacy and safety of Toripalimab alone or in combination with the TP regimen (albumin-bound paclitaxel + cisplatin) as neoadjuvant therapy for locally advanced head and neck squamous cell carcinoma patients.

药物成份或治疗方案详述：

具体治疗方案：特瑞普利单抗注射液240mg/3w，静脉滴注，输注时间60min以上，于放化疗前1h输注。化疗：顺铂剂量为80--100 mg/m²/3w，用法：输注时间60分钟以上，周期：每3周1次；紫杉醇135–175 mg/m²/3w，用法：静脉滴注3小时周期：每3周1次。

Description for medicine or protocol of treatment in detail：

**Specific Treatment Protocol:** - **Toripalimab Injection:** 240 mg every 3 weeks, administered by intravenous drip over a period of ≥60 minutes. Infusion should be completed 1 hour prior to radiotherapy and chemotherapy. - **Chemotherapy:** - **Cisplatin:** 80–100 mg/m² every 3 weeks, administered by intravenous drip over ≥60 minutes. - **Paclitaxel:** 135–175 mg/m² every 3 weeks, administered by intravenous drip over 3 hours. - **Cycle Frequency:** Both chemotherapy agents are administered once every 3 weeks.

纳入标准：

Inclusion criteria

1.  Age: >=18 years, male or female;
2.  Histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx);
3.  Clinically staged as III or IV (according to AJCC 8th edition) locally advanced HNSCC (LA-HNSCC) that is surgically resectable, with at least one measurable lesion (per RECIST criteria), and no evidence of distant metastasis;
4.  ECOG Performance Status score: 0-1;
5.  Imaging studies show no evidence of distant metastasis;
6.  Expected survival >=6 months;
7.  Normal function of major organs, meeting the following criteria:
 (1).matological tests must meet (no blood transfusion within 14 days prior to screening):
 1) . Hemoglobin (HB) >=80 g/L;
 2).  Absolute Neutrophil Count (ANC) >=1.0 × 10^9/L;
 3).  Platelets (PLT) >=80 × 10^9/L.
 (2)Biochemical tests must meet the following standards (no blood or blood product transfusion within 14 days prior to screening):
1).  Total Bilirubin (BIL) <1.5 × Upper Limit of Normal (ULN);
2) . ALT and AST <2.5 × ULN.
8.  All patients must undergo testing for tumor PD-L1 expression level (Combined Positive Score, CPS). Patients with a CPS >=1 will be enrolled;
    *   CPS = (Number of PD-L1 membrane-staining positive tumor cells + Number of PD-L1 positive tumor-associated immune cells) / Total number of tumor cells × 100.
9.  Patient has no known immune system diseases, such as systemic lupus erythematosus or other autoimmune diseases, that may affect the safety or efficacy of immunotherapy. Patient has no history of taking immunosuppressants or is not receiving long-term immunosuppressive therapy;
10. Patient has not received prior systemic chemotherapy, radiotherapy, or immunotherapy for head and neck cancer. Local treatments such as surgery or ablation are allowed but must have been completed at least 4 weeks prior to enrollment, with good recovery from such treatment;
11. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and be willing to use reliable methods of contraception during the trial. Male subjects must agree to use reliable contraception from the start of treatment until 120 days after the last dose;
12. The subject voluntarily agrees to participate in this study, signs the informed consent form, demonstrates good compliance, and agrees to cooperate with follow-up.

排除标准：

1 .妊娠或哺乳，或者计划在研究期内妊娠 2 .患有活动性自身免疫性疾病或免疫缺陷病，包括但不限于重症肌无力、间质性肺炎、肠炎、自身免疫性肝炎、垂体炎、血管炎、肾炎、甲状腺功能亢进，3 、HIV 检测阳性或有上述疾病病史，或有器官移植史； 4 .开始研究治疗前 2 周内接受全身免疫抑制药物治疗，或预期研究治疗期间需要全身免疫抑制药物治疗； 5 .在开始研究治疗前 4 周内接受过全身免疫刺激剂治疗（包括但不限于干扰素或白介素-2[IL-2]）或仍在 5 个药物半衰期内（取二者中较长者）； 6 .既往 5 年内有其它恶性肿瘤病史，但已治愈的宫颈原位癌、非黑色素瘤皮肤癌、局限性前列腺癌、原位导管癌除外； 7 .开始研究治疗前 3 个月内发生严重的心血管疾病（如，纽约心脏病学会心脏疾病Ⅱ 级或Ⅱ级以上心脏病、心肌梗死或脑血管意外）、不稳定型心律失常或不稳定型心绞痛； 8 .受试者有活动性感染或传染性疾病，或在筛选期间、首次给药前发生原因不明的发热（体温>38.5℃); 9 .开始研究治疗前 2 周内接受过治疗性口服或静脉注射抗生素；接受预防性抗生素治疗（如预防泌尿道感染或慢性阻塞性肺病）的患者可入组。 10 .未经治疗的活动性肝炎（乙肝：HBsAg 阳性伴肝功能异常且HBV-DNA≥104ml；丙肝：HCV-RNA≥103/ml 或在研究期间需要进行抗病毒治疗）； 11 .入组前 4 周内接受了 PD-1/L1 抗体或 CTLA-4 抗体等免疫治疗；入组前 4 周内接受了化疗或者靶向治疗等； 12 .受试者已经参加或入组前 4 周内完成了其他临床试验； 13 .受试者在研究期间可能需要接受其他抗肿瘤治疗； 14 .受试者可能需要在研究期间接种疫苗或入组前 4 周内接种了疫苗； 15 .根据研究者的判断，有其他严重的危害患者安全或影响患者完成研究的伴随疾病的患者。

Exclusion criteria：

1. Pregnancy, lactation, or planning to become pregnant during the study period; 2. Presence of active autoimmune diseases or immunodeficiency disorders, including but not limited to myasthenia gravis, interstitial pneumonia, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or a history of such conditions or organ transplantation; 3. Positive HIV test result; 4. Receipt of systemic immunosuppressive drug therapy within 2 weeks prior to the start of study treatment, or anticipated need for systemic immunosuppressive drug therapy during the study; 5. Receipt of systemic immunostimulant therapy (including but not limited to interferon or interleukin-2 [IL-2]) within 4 weeks prior to the start of study treatment or still within 5 drug half-lives (whichever is longer); 6. History of other malignancies within the past 5 years, except for cured carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, or ductal carcinoma in situ; 7. Occurrence of severe cardiovascular diseases within 3 months prior to the start of study treatment (e.g., NYHA Class II or higher heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmias, or unstable angina; 8. Active infection or contagious disease, or unexplained fever (body temperature > 38.5°C) during screening or before the first dose; 9. Receipt of therapeutic oral or intravenous antibiotics within 2 weeks prior to the start of study treatment. Patients receiving prophylactic antibiotic therapy (e.g., for urinary tract infections or chronic obstructive pulmonary disease) may be enrolled; 10. Untreated active hepatitis (Hepatitis B: HBsAg positive with abnormal liver function and HBV-DNA >= 10^4 IU/mL; Hepatitis C: HCV-RNA >= 10^3 IU/mL or requiring antiviral therapy during the study period); 11. Receipt of immunotherapy such as PD-1/L1 or CTLA-4 antibodies within 4 weeks prior to enrollment; receipt of chemotherapy or targeted therapy within 4 weeks prior to enrollment; 12. Participation in another clinical trial or completion of another clinical trial within 4 weeks prior to enrollment; 13. Potential need for other anti-tumor therapies during the study period; 14. Potential need for vaccination during the study period or receipt of vaccination within 4 weeks prior to enrollment; 15. Other severe comorbidities that, in the investigator’s judgment, may endanger the patient’s safety or affect the completion of the study.

研究实施时间：

Study execute time：

从 From 2026-01-20 00:00:00至 To 2028-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-01-20 00:00:00 至 To 2028-12-31 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：	特瑞普利单抗+白蛋白紫杉醇+顺铂	干预措施代码：
Intervention：	Trepilimab, albumin-bound paclitaxel, cisplatin	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	云南省	市(区县)：	昆明市
Country：	China	Province：	Yunnan Province	City：	Kunming City
单位(医院)：	云南省第一人民医院	单位级别：	三级甲等
Institution hospital：	The First People's Hospital of Yunnan Province	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	病理完全缓解率	指标类型：	主要指标
Outcome：	Pathological complete response rate	Type：	Primary indicator
测量时间点：	新辅助治疗（2 周期）结束接受手术治疗	测量方法：	病理分析
Measure time point of outcome：	Surgery was performed following the completion of 2 cycles of neoadjuvant therapy	Measure method：	Pathological analysis

指标中文名：	肿瘤客观缓解率	指标类型：	次要指标
Outcome：	Objective Response Rate	Type：	Secondary indicator
测量时间点：	每3个月	测量方法：	影像学评估
Measure time point of outcome：	at 3-month intervals	Measure method：	Imaging evaluation

指标中文名：	主要病理缓解	指标类型：	次要指标
Outcome：	Major pathological response	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	2年无进展生存率	指标类型：	次要指标
Outcome：	2-year progression-free survival rate	Type：	Secondary indicator
测量时间点：	治疗结束后2年	测量方法：	影像学评估
Measure time point of outcome：	2 years after the completion of treatment	Measure method：	Imaging evaluation

指标中文名：	2 年和 5 年生存率	指标类型：	次要指标
Outcome：	2-year and 5-year survival rates	Type：	Secondary indicator
测量时间点：	每3个月	测量方法：	电话随访
Measure time point of outcome：	at 3-month intervals	Measure method：	Telephone follow-up

指标中文名：	安全性	指标类型：	次要指标
Outcome：	Safety profile	Type：	Secondary indicator
测量时间点：	治疗过程中	测量方法：	临床医生评估
Measure time point of outcome：	During therapy	Measure method：	Clinician assessment

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	病理组织	组织：	肿瘤组织
Sample Name：	Pathological specimen	Tissue：	Tumor specimen
人体标本去向	使用后销毁	说明	使用后集中销毁
Fate of sample：	Destruction after use	Note：	Collected for centralized destruction after use

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		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）：

None

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：	None
Blinding：	None

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）：	none
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：	对所有填写了知情同意书并筛选合格进入试验的患者，均须认真而详细地记录病例报告表中的任何项目，不得空项或漏项(无记录的空格划横线)。病例报告表中所有数据需与受试者病历数据核对，保证无误。病例报告表作为原始数据，做任何更正时只能划线，旁注改后数据，并有研究者签名标注日期。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	For all patients who have signed the informed consent form and passed screening to enter the trial, every item in the Case Report Form (CRF) must be completed carefully and in detail. No fields should be left blank or omitted (for empty fields with no data, a horizontal line should be drawn). All data in the CRF must be verified against the subject's medical records to ensure accuracy. The CRF serves as original data. Any corrections must be made by drawing a single line through the incorrect entry, writing the corrected data next to it, and having the investigator initial and date the change.
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：	2026-01-19 16:08:04