ChiCTR2500109878 版本V1.0 版本创建时间2025/09/26 10:36:36 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：

 ChiCTR2500109878 

最近更新日期：

Date of Last Refreshed on：

 2025-09-26 10:36:19 

注册时间：

Date of Registration：

 2025-09-26 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联合化疗一线治疗复发和/或转移性头颈部鳞状细胞癌的前瞻性、单臂II期临床研究

Public title：

Cetuximab β combined with chemotherapy as first-line treatment for recurrent and/or metastatic head and neck squamous cell carcinoma: A prospective, single-arm, phase II clinical study

注册题目简写：

ZhangCN-01

English Acronym：

ZhangCN-01

研究课题的正式科学名称：

西妥昔单抗β联合化疗一线治疗复发和/或转移性头颈部鳞状细胞癌的前瞻性、单臂II期临床研究

Scientific title：

Cetuximab β combined with chemotherapy as first-line treatment for recurrent and/or metastatic head and neck squamous cell carcinoma: A prospective, 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：

张建文 

研究负责人：

张建文 

Applicant：

Zhang Jianwen 

Study leader：

Zhang Jianwen 

申请注册联系人电话：

Applicant telephone：

 +86 181 2197 0701

研究负责人电话：

Study leader's
telephone：

+86 181 2197 0701

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：

 zhangjianwen66@126.com

研究负责人电子邮件：

Study leader's E-mail：

 zhangjianwen66@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 The Affiliated Hospital of Southwest Medical University

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：

西南医科大学附属医院肿瘤科

研究负责人通讯地址：

西南医科大学附属医院肿瘤科,646000

Applicant address：

Oncology Department, the Affiliated Hospital of Southwest Medical University. No. 23 Taiping Street, Jiangyang District, Luzhou, Sichuan Province.

Study leader's address：

Oncology Department, the Affiliated Hospital of Southwest Medical University. No. 23 Taiping Street, Jiangyang District, Luzhou, Sichuan Province. 646000

申请注册联系人邮政编码：

Applicant postcode：

 646000

研究负责人邮政编码：

Study leader's postcode：

 646000

申请人所在单位：

西南医科大学附属医院

Applicant's institution：

the Affiliated Hospital of Southwest Medical University

研究负责人所在单位：

西南医科大学附属医院

Affiliation of the Leader：

the Affiliated Hospital of Southwest 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：

 KY2025243

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：

西南医科大学附属医院临床试验伦理委员会

Name of the ethic committee：

Clinical Trial Ethics Committee of the Affiliated Hospital of Southwest Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-04-28 00:00:00

伦理委员会联系人：

张曾瑞

Contact Name of the ethic committee：

Zhang Zengrui

伦理委员会联系地址：

四川省泸州市江阳区太平街23号

Contact Address of the ethic committee：

No. 23 Taiping Street, Jiangyang District, Luzhou, Sichuan Province.

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 830 316 5273

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 zhangjianwen66@126.com

研究实施负责（组长）单位：

西南医科大学附属医院

Primary sponsor：

Affiliated Hospital of Southwest Medical University

研究实施负责（组长）单位地址：

四川省泸州市江阳区太平街23号

Primary sponsor's address：

No. 23 Taiping Street, Jiangyang District, Luzhou, Sichuan 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)：

四川省

市(区县)：

Country：

China

Province：

Sichuan

City：

单位(医院)：

西南医科大学附属医院

具体地址：

四川省泸州市江阳区太平街23号

Institution
hospital：

The Affiliated Hospital of Southwest Medical University

Address：

No. 23 Taiping Street, Jiangyang District, Luzhou, Sichuan Province.

经费或物资来源：

四川省医学科技创新研究会

Source(s) of funding：

Sichuan Provincial Medical Science and Technology Innovation Research Association

研究疾病：

复发和/或转移性头颈部鳞状细胞癌  

Target disease：

recurrent and/or metastatic 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：

评价西妥昔单抗β联合化疗一线治疗复发和/或转移性头颈部鳞状细胞癌的有效性和安全性。  

Objectives of Study：

Evaluation of the Efficacy and Safety of Cetuximab β Combined with Chemotherapy as First-Line Treatment for Recurrent and/or Metastatic Head and Neck Squamous Cell 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.入组前签署书面知情同意书； 2.年龄18-75岁，男女不限； 3.经组织学或细胞学确认诊断的头颈部鳞状细胞癌（SCCHN）； 4.不适合接受局部区域治疗的复发和/或转移性SCCHN。仅患有复发性疾病（无转移）的患者既往必须接受放疗（作为手术后辅助治疗或者作为局部晚期SCCHN 的治疗）作为“局部区域治疗”，并且放疗必须在筛选影像检查前6个多月完成。 5.具有≥1个可测量病灶（根据RECIST 1.1标准）； 6.ECOG评分：0～2； 7.具有足够的器官功能： (1)血常规：ANC≥1.5×10^9/L；PLT≥100×10^9/L；HGB≥90 g/L ； (2)肝功能：AST≤2.5×ULN或≤5×ULN（对于存在肝转移的患者）；ALT≤2.5×ULN或≤5×ULN（对于存在肝转移的患者）；TBIL≤1.5×ULN； (3)肾功能：Cr≤1.5×ULN 或 CrCl ≥60 mL/min（（如果计算的肌酐清除率<60mL/分，研究者可以要求24小时肌酐清除率检查以便进行确认）。）； (4)纠正后的校正血清钙、血钾和血镁值在正常范围之内（允许在筛选期间纠正电解质）； 8.预估生存期≥3个月；在研究治疗开始前2周至研究结束后3个月内无生育及哺乳计划。

Inclusion criteria

1. Signed a written informed consent form prior to enrollment; 2. Aged 18–75 years, regardless of gender; 3. Diagnosed with head and neck squamous cell carcinoma (SCCHN) confirmed by histology or cytology; 4. Recurrent and/or metastatic SCCHN not suitable for locoregional treatment. For patients with only recurrent disease (without metastasis), they must have previously received radiotherapy (as adjuvant therapy after surgery or as treatment for locally advanced SCCHN) as "locoregional treatment", and the radiotherapy must have been completed more than 6 months before the screening imaging examination; 5. Having >= 1 measurable lesion (in accordance with the RECIST 1.1 criteria); 6. ECOG performance status score: 0–2; 7. Adequate organ function, as defined by: (1) Routine blood test: Absolute Neutrophil Count (ANC) >= 1.5×10?/L; Platelet (PLT) >= 100×10?/L; Hemoglobin (HGB) >= 90 g/L; (2) Liver function: Aspartate Aminotransferase (AST) <= 2.5×Upper Limit of Normal (ULN) or <= 5×ULN (for patients with liver metastasis); Alanine Aminotransferase (ALT) <= 2.5×ULN or <= 5×ULN (for patients with liver metastasis); Total Bilirubin (TBIL) <= 1.5×ULN; (3) Renal function: Serum Creatinine (Cr) <= 1.5×ULN or Creatinine Clearance (CrCl) >= 60 mL/min (if the calculated CrCl < 60 mL/min, the investigator may require a 24-hour CrCl test for confirmation); (4) Corrected serum calcium, potassium, and magnesium levels within the normal range (electrolyte correction is permitted during the screening period); 8. Estimated survival time >= 3 months; No plans for pregnancy, childbirth, or breastfeeding from 2 weeks before the start of study treatment to 3 months after the end of the study.

排除标准：

1.接受过系统化疗，但不包括作为多模式治疗的一个环节针对局部晚期疾病进行的化疗（此项治疗必须距试验开始完成超过6个月）。 2.入组前4周之内接受过重大手术或放射治疗。 3.既往接受过以EGFR为靶点的单克隆抗体或信号转导抑制剂治疗。 4.鼻咽癌。 5.已知对于本试验治疗的任何成分会产生过敏反应。 6.活动性感染，包括活动性结核、已知和确证的人免疫缺陷病毒（HIV）感染或引起肝功能损害或硬化的活动性乙型/丙型肝炎病毒感染（HBV/HCV）。 7.器官同种移植、自体/异体干细胞移植和肾脏替代治疗史。 8.无症状性重度高血压或高血压危象，定义为静息状态收缩压≥180 mmHg和/或舒张压≥110 mmHg。 9.心脏功能损害，表现为任何下列状况： 左心室射血分数<45%；严重心律失常；不稳定性心绞痛；纽约心脏协会III或IV级充血性心力衰竭；随机化之前近12个月之内发生过心肌梗塞；心包积液。 10.已知发生了中枢神经系统转移和/或软脑膜疾病。有症状的受试者应接受一次脑部CT/MRI检查以排除脑转移。 11.已知未得到控制的糖尿病、肺纤维化、间质性肺病、急性肺病或肝衰竭。 12. ≥2级外周神经疾病或听力丧失。 13.未从既往手术、化疗或放疗的任何急性影响中恢复，即未降至≤1级（CTCAE，版本5.0）的受试者。如果营养状态稳定，允许既往放疗和/或手术产生的慢性晚期毒性（咽/喉毒性，即口腔干燥，言语、吞咽异常等）。 14.已知酒精和/或药物滥用。 15.会妨碍受试者完成试验或签署知情同意书的医学或心理状况。 16.具有SCCHN以外肿瘤的病史或现病史，不包括经根治性治疗的非黑色素皮肤癌、原位宫颈癌，或者其他经过根治性治疗且至少5年无疾病迹象的癌症。 17.入组前30天之内接受过任何研究药物。 18.孕妇（未经血清β-人绒毛膜促性腺激素[HCG]试验确认）或哺乳期女性受试者，或者具有生育能力而不愿或不能够采用一种高效节育/避孕方法以防止在接受试验治疗之前2周到接受最后一剂试验治疗之后3个月期间发生妊娠的男性和女性。高效避孕方法定义为坚持正确使用时失败率较低（每年<1%）的避孕方法。 19.同时接受一种方案规定的禁用药物治疗。 20.具有任何研究者判定可能会损害本试验开展的并存的医学情况或疾病的受试者无法律行为能力/限制行为能力。

Exclusion criteria：

1. Having received systemic chemotherapy, excluding chemotherapy administered as part of multimodal therapy for locally advanced disease (such chemotherapy must have been completed more than 6 months before the start of the trial). 2. Having undergone major surgery or radiotherapy within 4 weeks prior to enrollment. 3. A history of prior treatment with epidermal growth factor receptor (EGFR)-targeted monoclonal antibodies or signal transduction inhibitors. 4. Nasopharyngeal carcinoma. 5. Known history of hypersensitivity (allergic reactions) to any component of the study treatment. 6. Active infections, including active tuberculosis, known and confirmed human immunodeficiency virus (HIV) infection, or active hepatitis B virus (HBV)/hepatitis C virus (HCV) infection that causes liver function impairment or cirrhosis. 7. History of solid organ transplantation, autologous/allogeneic stem cell transplantation, or renal replacement therapy. 8. Asymptomatic severe hypertension or hypertensive emergency, defined as resting systolic blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110 mmHg. 9. Cardiac function impairment, manifested by any of the following conditions: left ventricular ejection fraction (LVEF) < 45%; severe arrhythmia; unstable angina pectoris; New York Heart Association (NYHA) Class III or IV congestive heart failure; myocardial infarction occurring within the past 12 months before randomization; pericardial effusion. 10. Known central nervous system (CNS) metastasis and/or leptomeningeal disease. Symptomatic subjects should undergo a brain computed tomography (CT)/magnetic resonance imaging (MRI) scan to rule out brain metastasis. 11. Known uncontrolled diabetes mellitus, pulmonary fibrosis, interstitial lung disease, acute lung disease, or liver failure. 12. Grade >= 2 peripheral neuropathy or hearing loss. 13. Subjects who have not recovered from any acute effects of prior surgery, chemotherapy, or radiotherapy (i.e., the effects have not resolved to Grade <= 1 per the Common Terminology Criteria for Adverse Events [CTCAE], Version 5.0). Chronic late toxicities from prior radiotherapy and/or surgery (such as pharyngeal/laryngeal toxicities: xerostomia, speech or swallowing disorders, etc.) are permitted if the nutritional status is stable. 14. Known history of alcohol and/or substance abuse. 15. Medical or psychological conditions that would prevent the subject from completing the trial or signing the informed consent form. 16. A history (past or current) of malignancies other than squamous cell carcinoma of the head and neck (SCCHN), excluding the following: non-melanoma skin cancer treated with curative intent, carcinoma in situ of the cervix, or other cancers treated with curative intent and with no evidence of disease for at least 5 years. 17. Having received any investigational drug within 30 days prior to enrollment. 18. Pregnant subjects (not confirmed by serum beta-human chorionic gonadotropin [β-HCG] test) or breastfeeding women; or men and women of childbearing potential who are unwilling or unable to use a highly effective contraceptive method to prevent pregnancy from 2 weeks before receiving the study treatment to 3 months after the last dose of the study treatment. A highly effective contraceptive method is defined as one with a low failure rate (< 1% per year) when used correctly and consistently. 19. Concurrently receiving treatment with any protocol-specified prohibited medications. 20. Subjects with legal incompetence/restricted capacity, or those with comorbid medical conditions or diseases deemed by the investigator to potentially impair the conduct of the trial.

研究实施时间：

Study execute time：

从 From 2025-06-30 00:00:00至 To 2026-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-09-30 00:00:00 至 To 2026-07-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 20

Group：

Test group

Sample size：

干预措施：

西妥昔单抗β联合化疗

干预措施代码：

Intervention：

Cetuximab β combined with chemotherapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

 泸州 

Country：

China

Province：

Sichuan

City：

Luzhou

单位(医院)：

 西南医科大学附属医院 

单位级别：

 三甲 

Institution
hospital：

The Affiliated Hospital of Southwest Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

客观缓解率

指标类型：

主要指标

Outcome：

Objective Response 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：

疾病控制率

指标类型：

次要指标

Outcome：

disease control 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：

无进展生存期

指标类型：

次要指标

Outcome：

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：

总生存期

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：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

Not Applicable

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 18 岁 years
最大 Max age 75 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)：

Not Applicable

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

是Yes

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）：

文章发表

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Article Publication

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(Case Record Form, CRF)

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

Case Record Form

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：

  2025-09-26 10:36:19