ChiCTR2500107060 版本V1.0 版本创建时间2025/08/01 19:35:05 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：

ChiCTR2500107060 

最近更新日期：

Date of Last Refreshed on：

2025-08-01 19:34:47 

注册时间：

Date of Registration：

2025-08-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

依沃西单抗联合多西他赛加顺铂诱导治疗局部晚期头颈部鳞状细胞癌的前瞻性，单臂，II期临床研究

Public title：

A prospective, single-arm, phase II clinical study of ivocizumab combined with docetaxel and cisplatin induction therapy for locally advanced head and neck squamous cell carcinoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

依沃西单抗联合多西他赛加顺铂诱导治疗局部晚期头颈部鳞状细胞癌的前瞻性，单臂，II期临床研究

Scientific title：

A prospective, single-arm, phase II clinical study of ivocizumab combined with docetaxel and cisplatin induction therapy for locally advanced head and neck squamous cell carcinoma

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：

周行 

研究负责人：

周行 

Applicant：

Hang Zhou 

Study leader：

Hang Zhou 

申请注册联系人电话：

Applicant telephone：

+86 18908190258

研究负责人电话：

Study leader's telephone：

+86 28 85420295

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：

zhouhang_1024@163.com

研究负责人电子邮件：

Study leader's E-mail：

zhouhang_1024@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：

成都市武侯区人民南路四段55号

研究负责人通讯地址：

成都市武侯区人民南路四段55号

Applicant address：

No. 55, Section 4, Renmin South Road, Wuhou District, Chengdu City

Study leader's address：

No. 55, Section 4, Renmin South Road, Wuhou District, Chengdu City

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：

四川省肿瘤医院

Applicant's institution：

Sichuan Cancer Hospital

研究负责人所在单位：

四川省肿瘤医院

Affiliation of the Leader：

Sichuan Cancer Hospital

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：

SCCHEC-02-2024-243

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：

四川省肿瘤医院医学科研与医疗新技术伦理委员会

Name of the ethic committee：

Ethics Committee for Medical Research and New Medical Technology of Sichuan Cancer Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-12-18 00:00:00

伦理委员会联系人：

王青青

Contact Name of the ethic committee：

Wang Qingqing

伦理委员会联系地址：

成都市武侯区人民南路四段55号

Contact Address of the ethic committee：

No. 55, Section 4, Renmin South Road, Wuhou District, Chengdu City

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 28 85420681

伦理委员会联系人邮箱：

Contact email of the ethic committee：

975095403@qq.com

研究实施负责（组长）单位：

四川省肿瘤医院

Primary sponsor：

Sichuan Cancer Hospital

研究实施负责（组长）单位地址：

成都市武侯区人民南路四段55号

Primary sponsor's address：

No. 55, Section 4, Renmin South Road, Wuhou District, Chengdu City

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)：

四川省肿瘤医院

具体地址：

成都市武侯区人民南路四段55号

Institution
hospital：

Sichuan Cancer Hospital

Address：

No. 55, Section 4, Renmin South Road, Wuhou District, Chengdu City

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

None

Target disease：

Locally Advanced Head and Neck Squamous Cell 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：

基于意向治疗（ITT）分析集评估依沃西单抗联合多西他赛加顺铂诱导治疗局部晚期头颈鳞癌的客观缓解率（ORR）  

Objectives of Study：

Evaluation of the objective response rate (ORR) of ivocizumab combined with docetaxel plus cisplatin induction therapy for locally advanced head and neck squamous cell carcinoma based on the intention-to-treat (ITT) analysis set.

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.筛选前自愿签署书面知情同意书；
2.年龄18-65岁；
3.ECOG体能状态评分0-1；
4.经组织学或病理学确诊的头颈部鳞状细胞癌(口腔、口咽、喉、下咽、副鼻窦)；对于口腔和口咽部肿瘤HPV状态需已知；
5.初治分期为局部晚期（III-IVB期，AJCC第8版）且经外科评估后无法根治性切除；
6.根据实体瘤疗效评价标准（RECIST版本1.1），有可评估的病灶；
7.器官功能充分，定义为在治疗之前≤14天达到以下实验室检查结果（患者在采集血样之前14天内不得因中性粒细胞计数、血小板或血红蛋白低于研究要求而接受过输血或生长因子支持）：（1）患者必须符合下列实验室检查结果：绝对中性粒细胞计数 ≥ 1.5×10^9/L，血小板 ≥ 100×10^9/L，血红蛋白 ≥ 90g/L；（2）治疗前4周内的肾功能要求: 内生肌酐清除率 ≥ 60mL/min.（根据24小时尿肌酐计算或 Cockcroft-Gault公式法）；（3）血清总胆红素 ≤ 1.5倍正常范围上限（ULN）（Gilbert综合征患者若总胆红素 ＜ 3倍ULN则可以入组）；（4） AST和ALT ≤ 3倍ULN；
8.存在乙型肝炎病毒（HBV）感染的患者以及非活动性/无症状的HBV携带者，或存在慢性或活动性HBV的患者；在筛选时如果HBV DNA ＜ 2000 copies/mL将允许入组；丙型肝炎抗体阳性的患者，在筛选时如果HCV-RNA阴性将允许入组；
9.育龄期女性（WOCBP）须愿意在研究期间、以及最后一次研究治疗（包括化疗）给药后 ≥ 60天采取高效避孕措施，在治疗前 ≤ 7天内尿液或血清妊娠检测结果为阴性；育龄期女性定义为任何已经有过月经初潮并且没有做过绝育手术（子宫切除术或双侧卵巢切除术）且还没有绝经的女性；绝经定义为 ＞ 45岁的女性在没有其他生物学或生理学原因的情况下闭经12个月；此外为确认绝经，年龄在55岁以下的女性血清促卵泡激素（FSH）的水平必须 ＞ 40mIU/mL；
10.未绝育的男性受试者须愿意在研究期间及最后一次研究治疗（包括化疗）给药后 ≥ 60天内采取高效避孕措施；

Inclusion criteria

1. Voluntary written informed consent before screening; 2.Age 18-65 years old; 3.ECOG performance status score 0-1; 4. Histologically or pathologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, larynx, hypopharynx, paranasal sinuses);HPV status for oral and oropharyngeal tumors must be known; 5.The initial treatment stage is locally advanced (stage III-IVB, AJCC 8th edition) and cannot be radically resected after surgical evaluation; 6.According to the solid tumor response evaluation criteria (RECIST version 1.1), there are evaluable lesions; 7.Adequate organ function, defined as the following laboratory test results <=14 days before treatment (patients must not have received blood transfusions or growth factor support within 14 days before blood sampling due to neutrophil counts, platelets or hemoglobin below the study requirements): (1) Patients must meet the following laboratory test results: absolute neutrophil count >= 1.5×10^9/L, platelets >= 100×10^9/L, hemoglobin >= 90g/L;(2)Renal function requirements within 4 weeks before treatment: endogenous creatinine clearance >= 60mL/min. (calculated based on 24-hour urine creatinine or Cockcroft-Gault formula);(3)Serum total bilirubin <= 1.5 times the upper limit of normal range (ULN) (Gilbert syndrome patients can be included if the total bilirubin is < 3 times ULN);(4) AST and ALT <= 3 times ULN; 8. Patients with hepatitis B virus (HBV) infection and inactive/asymptomatic HBV carriers, or patients with chronic or active HBV;if HBV DNA < 2000 copies/mL at screening will be allowed to enroll;patients with positive hepatitis C antibodies will be allowed to enroll if HCV-RNA is negative at screening; 9.Women of childbearing age (WOCBP) must be willing to take highly effective contraceptive measures during the study and for >= 60 days after the last study treatment (including chemotherapy), and have a negative urine or serum pregnancy test result <= 7 days before treatment;women of childbearing age are defined as any woman who has had menarche and has not undergone sterilization surgery (hysterectomy or bilateral oophorectomy) and has not yet menopausal;menopause is defined as women aged > 45 years with 12 months of amenorrhea without other biological or physiological reasons;in addition, to confirm menopause, women under the age of 55 must have a serum follicle-stimulating hormone (FSH) level of > 40mIU/mL; 10.Male subjects who are not sterilized must be willing to take highly effective contraceptive measures during the study and for >= 60 days after the last study treatment (including chemotherapy).

排除标准：

1.既往曾接受过针对肿瘤的任何治疗；
2.曾接受以PD-1、PD-L1，PD-L2、CTLA4和VEGF为靶点的治疗；
3.经病理判定为HPV阳性的口腔或口咽鳞癌；
4.有瘘管（食管/支气管或食管/主动脉）的证据的患者；
5.有活动性自身免疫性疾病或者有自身免疫性疾病史但可能复发的患者（以下疾病的患者不排除，可以进入进一步筛选：（1）可控的1型糖尿病；（2）甲状腺机能减退（如果仅用激素替代疗法可以控制）；（3）可控的乳糜泻；（4）无需全身治疗的皮肤病（例如白癜风、银屑病、脱发）；（5）如无外部触发因素则预期不会复发的其它任何疾病）；
6.在治疗之前 ≤ 2年内有任何活动性恶性肿瘤，本研究中正在研究的特定癌症以及已经治愈的局部复发性癌症（例如切除的基底细胞或鳞状细胞性皮肤癌，浅表性膀胱癌，原位宫颈癌或乳腺癌）除外；
7.在治疗之前 ≤ 14天内有任何需要用皮质类固醇全身治疗（剂量高于10mg/日的强的松或同类药物同等剂量）或其它免疫抑制剂治疗的病症；目前或之前曾使用过以下任何类固醇方案的患者可以入选：（1） 肾上腺素替代性类固醇（强的松≤10mg/日或同类药物同等剂量）；（2）全身吸收量极小的局部、眼用、关节内、鼻内和吸入性皮质类固醇；（3）预防性地短期（≤7天）使用皮质类固醇（例如，预防造影剂过敏）或用于治疗非自身免疫病症（例如由接触过敏原引起的迟发型超敏反应）；
8.有间质性肺病、非感染性肺炎或未控的疾病史，包括肺纤维化、急性肺病等；
9.在治疗前14天内存在需要给予全身抗菌剂、抗真菌剂或抗病毒治疗的重度慢性或活动性感染（包括肺结核感染等）；
10.已知有HIV感染史；
11.在治疗之前 ≤ 28天内曾进行任何必须全身麻醉的大手术；
12.既往曾进行同种异体干细胞移植或者器官移植；
13.有以下任何心血管风险因素：（1）在治疗之前 ≤ 28天内出现心源性胸痛，定义为限制日常生活的器具性活动的中度疼痛；（2）治疗之前 ≤ 28天内曾出现症状性肺栓塞；（3）治疗之前 ≤ 6个月内曾发生急性心肌梗塞；（4）在治疗之前 ≤ 6个月内有达到纽约心脏病协会III或IV级的任何心力衰竭史；（5）在治疗之前 ≤ 6个月内曾发生 ≥ 2级的室性心律失常；（6）在治疗之前 ≤ 6个月内曾发生脑血管意外；（7）未控的高血压：尽管在治疗前或研究药物首次给药前 ≤ 28天内使用了降压药，仍然收缩压 ≥ 160mmHg或舒张压 ≥ 100mmHg（8）在治疗前 ≤ 28天曾出现任何晕厥或惊厥发作；
14.曾有对其它单克隆抗体严重超敏反应史；
15.在研究药物首次给药前14天内曾接受用于控制癌症的中草药或中成药；
16.在治疗之前 ≤ 4周内曾接受活疫苗注射（季节性流感疫苗通常是灭活疫苗，允许使用；鼻腔内使用的疫苗是活疫苗，不允许使用）；
17.存在不利于研究药物给药或影响药物毒性或AE的解读，或者可能使受试者在研究期间的依从性降低的基础医学状况（包括实验室检查值异常）或酒精/药物滥用或依赖；
18.同时参加另一项治疗性临床试验；
19.哺乳期女性；
20.在治疗前 ≤ 14天，存在未控的糖尿病、尽管进行了标准药物治疗仍 ＞ 1级的钾、钠或校正钙实验室检查值异常或 ≥ 3级的低白蛋白血症； 21)在研究药物首次给药前14天或5个半衰期内（以较长者为准），曾接受过任何化疗、免疫治疗（例如白介素、干扰素、胸腺素）或任何研究治疗；
21.在研究药物首次给药前14天或5个半衰期内（以较长者为准），曾接受过任何化疗、免疫治疗（例如白介素、干扰素、胸腺素）或任何研究治疗；

Exclusion criteria：

1.Patients who have received any treatment for tumors in the past; 2. Patients who have received treatment targeting PD-1, PD-L1, PD-L2, CTLA4 and VEGF; 3.Oral or oropharyngeal squamous cell carcinoma diagnosed as HPV positive by pathology; 4.Patients with evidence of fistula (esophagus/bronchus or esophagus/aorta); 5. Patients with active autoimmune diseases or a history of autoimmune diseases but with possible recurrence (patients with the following diseases are not excluded and can enter further screening: (1) Controllable type 1 diabetes;(2) Hypothyroidism (if it can be controlled with hormone replacement therapy alone);(3) Controllable celiac disease; (4) Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia);(5) Any other diseases that are not expected to recur if there are no external triggers); 6. <= 2 before treatment Any active malignancy within the year, excluding the specific cancer being studied in this study and locally recurrent cancer that has been cured (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical cancer in situ, or breast cancer); 7. Any condition requiring systemic treatment with corticosteroids (doses greater than 10 mg/day of prednisone or equivalent) or other immunosuppressive agents within <= 14 days before treatment;patients who are currently or have previously used any of the following steroid regimens can be included: (1) Adrenaline replacement steroids (prednisone <=10mg/day or equivalent dose of similar drugs);(2) topical, ophthalmic, intra-articular, intranasal and inhaled corticosteroids with minimal systemic absorption;(3) short-term (<=7 days) use of corticosteroids for prevention (e.g., prevention of contrast agent allergy) or for the treatment of non-autoimmune diseases (e.g., delayed hypersensitivity reactions caused by contact allergens); 8. History of interstitial lung disease, non-infectious pneumonia or uncontrolled diseases, including pulmonary fibrosis, acute lung disease, etc. 9.Severe chronic or active infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal or antiviral treatment within 14 days before treatment; 10.Known history of HIV infection; 11.Any major surgery requiring general anesthesia within <= 28 days before treatment; 12. Previous allogeneic stem cell transplantation or organ transplantation; 13.Any of the following cardiovascular risk factors: (1) cardiac chest pain, defined as moderate pain that limits instrumental activities of daily life, within 28 days before treatment; (2) symptomatic pulmonary embolism within 28 days before treatment; (3) acute myocardial infarction within 6 months before treatment; (4) any history of heart failure reaching New York Heart Association class III or IV within 6 months before treatment; (5) ventricular arrhythmia of >= grade 2 within 6 months before treatment; (6) cerebrovascular accident within 6 months before treatment; (7) uncontrolled hypertension: systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg despite the use of antihypertensive drugs within 28 days before treatment or before the first dose of study drug; (8) any syncope or seizure within 28 days before treatment; 14. History of severe hypersensitivity reaction to other monoclonal antibodies; 15. Received Chinese herbal medicine or Chinese patent medicine for cancer control within 14 days before the first dose of study drug; 16. Received live vaccine injection <= 4 weeks before treatment (seasonal influenza vaccine is usually inactivated vaccine, which is allowed; 8.intranasal vaccine is live vaccine, which is not allowed); 17. There are basic medical conditions (including abnormal laboratory values) that are not conducive to the administration of study drugs or affect the interpretation of drug toxicity or AE, or may reduce the subject's compliance during the study, or alcohol/drug abuse or dependence; 18.Participating in another therapeutic clinical trial at the same time; 19.Lactating women; 20. <= 14 days before treatment, there are uncontrolled diabetes, potassium, sodium or corrected calcium laboratory test values ??>= 1 grade abnormalities or >= Grade 3 hypoalbuminemia; 21.Patients who have received any chemotherapy, immunotherapy (e.g., interleukin, interferon, thymosin) or any study treatment within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug;

研究实施时间：

Study execute time：

从 From 2025-01-01 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-08-01 00:00:00 至 To 2027-12-31 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

20

Group：

Experimental Group

Sample size：

干预措施：

多西他赛+顺铂+依沃西单抗

干预措施代码：

Intervention：

Docetaxel + cisplatin + ivocizumab

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川省 

市(区县)：

  

Country：

China 

Province：

Sichuan 

City：

 

单位(医院)：

四川省肿瘤医院 

单位级别：

三级甲等 

Institution
hospital：

Sichuan Cancer Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

客观缓解率ORR

指标类型：

主要指标

Outcome：

ORR

Type：

Primary indicator

测量时间点：

3周期诱导化疗后

测量方法：

根据实体瘤疗效评价标准（RECIST版本1.1）

Measure time point of outcome：

After 3 cycles of induction chemotherapy

Measure method：

According to RECIST version 1.1

指标中文名：

1年的总生存率

指标类型：

次要指标

Outcome：

One year-OS

Type：

Secondary indicator

测量时间点：

从患者入组，观察时间1年

测量方法：

非参数方法（KM曲线）

Measure time point of outcome：

From patient enrollment, observation time 1 year

Measure method：

Kaplan-Meier

指标中文名：

1年的无事件发生率

指标类型：

次要指标

Outcome：

One year-EFS

Type：

Secondary indicator

测量时间点：

从患者入组，观察时间1年

测量方法：

非参数方法（KM曲线）

Measure time point of outcome：

From patient enrollment, observation time 1 year

Measure method：

Kaplan-Meier

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 18 岁 years
最大 Max age 65 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)：

NA

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：

无

Blinding：

None

是否共享原始数据：

IPD sharing

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）：

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：

CRF

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

CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-08-01 19:34:47