ChiCTR2500112241 版本V1.0 版本创建时间2025/11/11 17:55:54 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：

ChiCTR2500112241 

最近更新日期：

Date of Last Refreshed on：

2025-11-11 17:55:40 

注册时间：

Date of Registration：

2025-11-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

菲诺利单抗联合卡铂、白蛋白结合型紫杉醇用于可切除局晚期头颈鳞 癌治疗的前瞻性、单臂、II 期临床研究

Public title：

A Prospective, Single-Arm, Phase II Clinical Study of Finotonlimab Combined with Carboplatin and Nab-Paclitaxel in the Treatment of Resectable 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：

菲诺利单抗联合卡铂、白蛋白结合型紫杉醇用于可切除局晚期头颈鳞 癌治疗的前瞻性、单臂、II 期临床研究

Scientific title：

A Prospective, Single-Arm, Phase II Clinical Study of Finotonlimab Combined with Carboplatin and Nab-Paclitaxel in the Treatment of Resectable 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：

李博文 

研究负责人：

李劲松 

Applicant：

Li Bowen 

Study leader：

Li Jinsong 

申请注册联系人电话：

Applicant telephone：

+86 152 5609 9862

研究负责人电话：

Study leader's telephone：

+86 20 8133 2402

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：

1434547541@qq.com

研究负责人电子邮件：

Study leader's E-mail：

lijinsong1967@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：

广东省广州市中山大学孙逸仙纪念医院口腔科

研究负责人通讯地址：

广州市越秀区沿江西路107号

Applicant address：

Department of Stomatology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou City, Gu

Study leader's address：

No. 107 Yanjiang West Road, Guangzhou

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：

孙逸仙纪念医院

Applicant's institution：

Sun Yat-sen Memorial Hospital

研究负责人所在单位：

中山大学孙逸仙纪念医院

Affiliation of the Leader：

SUN YAT-SEN MEMORIAL 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：

SYSKY-2025-716-02

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：

中山大学孙逸仙纪念医院医学伦理委员会（第二）

Name of the ethic committee：

Medical Ethics Committee of Sun Yat-sen Memorial Hospital Sun Yat-sen University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-10-29 00:00:00

伦理委员会联系人：

区柳珊

Contact Name of the ethic committee：

Qu LiuShan

伦理委员会联系地址：

广州市越秀区沿江西路107号

Contact Address of the ethic committee：

No. 107 Yanjiang West Road, Guangzhou

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 20 8133 2587

伦理委员会联系人邮箱：

Contact email of the ethic committee：

liushan3219@163.com

研究实施负责（组长）单位：

中山大学孙逸仙纪念医院

Primary sponsor：

SUN YAT-SEN MEMORIAL HOSPITAL

研究实施负责（组长）单位地址：

广州市越秀区沿江西路107号

Primary sponsor's address：

No. 107 Yanjiang West Road, Guangzhou

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东省

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

中山大学孙逸仙纪念医院

具体地址：

广州市越秀区沿江西路107号

Institution
hospital：

SUN YAT-SEN MEMORIAL HOSPITAL

Address：

No. 107 Yanjiang West Road, Guangzhou

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-raised

Target disease：

Resectable locally advanced squamous cell carcinoma of the head and neck

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 上市后药物 

Study phase：

4

研究设计：

单臂 

Study design：

Single arm 

研究目的：

评估菲诺利单抗，联合卡铂+白蛋白紫杉醇新辅助治疗可切除局晚期头颈鳞癌（口腔鳞癌和口咽鳞癌）患者原发灶的主要病理缓解（MPR）；评估入组患者的病理完全缓解率（pCR）；评估入组患者的 1 年和 2 年的无事件生存率（event free survival rate，EFS rate）；评估入组患者的 1 年和 2 年的总生存率（overall rate，OS rate）；评估入组患者的客观响应率（ORR）率。  

Objectives of Study：

To evaluate the primary tumor's major pathological response (MPR) to neoadjuvant therapy with finolidimab in combination with carboplatin and nab-paclitaxel in patients with resectable locally advanced head and neck squamous cell carcinoma (oral squamous cell carcinoma and oropharyngeal squamous cell carcinoma); to assess the pathological complete response rate (pCR) in enrolled patients; to evaluate the 1-year and 2-year event-free survival (EFS) rates in enrolled patients; to determine the 1-year and 2-year overall survival (OS) rates in enrolled patients; and to assess the objective response rate (ORR) in enrolled patients.

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) 18 周岁≤年龄≤65 周岁； 2) 细胞学或组织学诊断为可手术切除的头颈鳞状细胞癌，分期如下： 临床分期III/IVA (cT1-2/cN1-2/M0 or cT3-4a/cN0-2/M0); 3) 根据实体肿瘤疗效评价标准（RECIST 1.1 版），至少有一处影像学可测量病灶；既往未接受过任何治疗的患者允许入组本研究； 4) ECOG 评分 0-1 分； 5) 预期生存时间>3 个月； 6) 足够器官功能，受试者需满足如下试验室指标： (1) 近 14 天未使用粒细胞集落刺激因子的情况下，中性粒细胞绝对值（ANC） ≥1.5x109/L； (2) 近 14 天未输血的情况下，血小板≥100×109/L； (3) 近 14 天内无输血或使用促红细胞生成素的情况下，血红蛋白≥90g/L； (4) 总胆红素≤1.5×正常值上限（ULN）； (5) 天门冬氨酸转氨酶（AST）、丙氨酸转氨酶（ALT）在≤2.5×ULN（有肝转移的患者允许 ALT 或 AST ≤5×ULN）； (6) 血肌酐≤1.5×ULN 并且肌酐清除率（采用 Cockcroft-Gault 公式计算） ≥60ml/min； 7) 凝血功能良好，定义为国际标准化比值（ INR）或凝血酶原时间（PT） ≤1.5倍 ULN； 8) 甲状腺功能正常，定义为促甲状腺激素（TSH）在正常范围内。如基线 TSH超出正常范围，如果总 T3（或 FT3）及 FT4 在正常范围内的受试者亦可入组； 9) 心肌酶谱在正常范围内（如研究者综合判断为不具有临床意义的单纯试验室异常也允许入组）； 10) 对于育龄期女性受试者，应在接受首次研究药物给药（第 1 周期第 1 天）之前的 3 天内接受尿液或血清妊娠试验且结果为阴性。如果尿液妊娠试验结果无法确认为阴性，则要求进行血液妊娠试验。非育龄期女性定义为绝经后至少１年，或进行过手术绝育或子宫切除术； 11) 如存在受孕风险，所有受试者（不论男性或女性）均需在整个治疗期间直至治疗末次研究药物给药后 120 天（或末次化疗药物给药后 180 天）内采用年失败率低于 1%的避孕措施。

Inclusion criteria

1) Age between 18 and 65 years old; 2) Cytological or histological diagnosis of surgically resectable head and neck squamous cell carcinoma, staged as follows: clinical stage III/IVA (cT1-2/cN1-2/M0 or cT3-4a/cN0-2/M0); 3) According to the RECIST 1.1 criteria for solid tumor efficacy evaluation, at least one measurable lesion on imaging; patients who have not received any prior treatment are eligible for this study; 4) ECOG score 0-1; 5) Expected survival time >3 months; 6) Sufficient organ function, with the following laboratory criteria: (1) Absolute neutrophil count (ANC) >= 1.5x10^9/L without the use of granulocyte colony-stimulating factor within the past 14 days; (2) Platelet count >= 100×10^9/L without blood transfusion in the past 14 days; (3) Hemoglobin >= 90 g/L without blood transfusion or use of erythropoiesis-stimulating agents in the past 14 days; (4) Total bilirubin <= 1.5× upper limit of normal (ULN); (5) AST and ALT <= 2.5×ULN (for patients with liver metastases, ALT or AST <= 5×ULN is allowed); (6) Serum creatinine <= 1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) >= 60 ml/min; 7) Good coagulation function, defined as INR or PT <= 1.5×ULN; 8) Normal thyroid function, defined as TSH within the normal range. Subjects with baseline TSH outside the normal range may also be enrolled if total T3 (or FT3) and FT4 are within the normal range; 9) Normal myocardial enzyme spectrum (subjects with minor isolated laboratory abnormalities deemed clinically insignificant by the investigator are also allowed); 10) For women of childbearing potential, a urine or serum pregnancy test must be performed within 3 days prior to the first administration of the study drug (Cycle 1, Day 1) and be negative. If the urine pregnancy test cannot confirm a negative result, a blood pregnancy test is required. Women not of childbearing potential are defined as postmenopausal for at least 1 year, or surgically sterile or having had a hysterectomy; 11) If there is a risk of pregnancy, all subjects (male and female) must use contraception with a failure rate of less than 1% throughout the treatment period and until 120 days after the last administration of the study drug (or 180 days after the last administration of chemotherapy).

排除标准：

1.首次给药前5年内诊断为头颈鳞癌之外的其他恶性疾病（不包括经过根治的皮肤基底细胞癌、皮肤鳞状上皮癌、和/或经过根治性切除的原位癌）；
2.当前正在参与干预性临床研究治疗，或在首次给药前4周内接受过其他研究药物或使用过研究器械治疗；
3.既往接受过下列疗法：抗PD-1、抗PD-L1或抗PD-L2药物或者针对另一种刺激或协同抑制T细胞受体（例如，CTLA-4、OX-40、CD137）的药物；
4.首次给药前2周内接受过具有抗头颈鳞状细胞癌适应症的中成药或免疫调节作用的药物（包括胸腺肽、干扰素、白介素，除外为控制胸水局部使用）系统性全身治疗；
5.首次给药前2年内发生过需要全身性治疗（例如使用缓解疾病药物、糖皮质激素或免疫抑制剂）的活动性自身性免疫疾病。替代疗法（例如甲状腺素、胰岛素或者用于肾上腺或垂体机能不全的生理性糖皮质激素等）不视为全身性治疗；
6.研究首次给药前7天内正在接受全身性糖皮质激素治疗（不包括喷鼻、吸入性或其他途径的局部糖皮质激素）或任何其他形式的免疫抑制疗法； 注：允许使用生理剂量的糖皮质激素（≤10 mg/天的泼尼松或等效药物）；
7.存在临床上不可控制的胸腔积液/腹腔积液（不需要引流积液或停止引流3天积液无明显增加的患者可以入组）；
8.已知异体器官移植（角膜移植除外）或异体造血干细胞移植；
9.已知对本研究药物菲诺利单抗、卡铂、白蛋白结合型紫杉醇的活性成分或辅料过敏者;
10.在开始治疗前，尚未从任何干预措施引起的毒性和/或并发症中充分恢复（即，≤1级或达到基线，不包括乏力或脱发）；
11.已知人类免疫缺陷病毒（HIV）感染史（即HIV 1/2抗体阳性）；
12.未经治疗的活动性乙肝（定义为HBsAg阳性同时检测到HBV-DNA拷贝数大于所在研究中心检验科正常值上限）； 注：符合下列标准的乙肝受试者亦可入组： 1) 首次给药前HBV病毒载量<1000拷贝/ml（200 IU/ml），受试者应在整个研究治疗期间接受抗HBV治疗避免病毒再激活 2) 对于抗HBc（+）、HBsAg（-）、抗HBs（-）和HBV病毒载量（-）的受试者，不需要接受预防性抗HBV治疗，但是需要密切监测病毒再激活；
13.活动性的HCV感染受试者（HCV抗体阳性且HCV-RNA水平高于检测下限）；
14.首次给药之前（第 1 周期，第 1 天）30 天内接种过活疫苗； 注：允许首次给药前 30 天内接受针对季节性流感的注射用灭活病毒疫苗；但是不允许接受鼻内用药的减毒活流感疫苗。
15.妊娠或哺乳期妇女；
16.存在任何严重或不能控制的全身性疾病，例如： 1) 静息心电图在节律、传导或形态上出现有重大且症状严重难以控制的异常，如完全性左束支传导阻滞，Ⅱ度以上心脏传导阻滞，室性心律失常或心房颤动； 2) 不稳定型心绞痛，充血性心力衰竭，纽约心脏病协会（NYHA）分级≥ 2 级的慢性心衰； 3) 在入选治疗前6个月内发生过任何动脉血栓、栓塞或缺血，如心肌梗死、不稳定型心绞痛、脑血管意外或一过性脑缺血发作等； 4) 血压控制不理想（收缩压＞140 mmHg，舒张压＞90 mmHg）； 5) 首次给药前1年内存在需要糖皮质激素治疗的非感染性肺炎病史，或当前存在临床活动性间质性肺病； 6) 活动性肺结核； 7) 存在需要全身性治疗的活动性或未能控制的感染； 8) 存在临床活动性憩室炎、腹腔脓肿、胃肠道梗阻； 9) 肝脏疾病如肝硬化、失代偿性肝病、急性或慢性活动性肝炎； 10) 糖尿病控制不佳（空腹血糖（FBG）＞10mmol/L）； 11) 尿常规提示尿蛋白≥++，且证实24小时尿蛋白定量＞1.0 g者；12) 存在精神障碍且无法配合治疗的患者；
17.有可能干扰试验结果、妨碍受试者全程参与研究的病史或疾病证据、治疗或试验室检查值异常，或研究者认为其他不适合入组的情况研究者认为存在其他潜在风险不适合参加本研究。

Exclusion criteria：

1.Within 5 years prior to the first administration, diagnosed with any other malignant disease other than head and neck squamous cell carcinoma (excluding skin basal cell carcinoma that has undergone radical treatment, skin squamous cell carcinoma, and/or carcinoma in situ that has undergone radical resection); 2.Currently participating in an intervention clinical study for treatment, or having received other study drugs or used study equipment within 4 weeks prior to the first administration; 3.Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, or drugs targeting another type of stimulatory or synergistic inhibitory T-cell receptor (for example, CTLA-4, OX-40, CD137); 4.Within 2 weeks prior to the first administration, the subject had received systemic and systemic treatment with traditional Chinese medicine or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, excluding those used locally to control pleural effusion) for the treatment of head and neck squamous cell carcinoma. 5.Within 2 years prior to the first administration, there has been an occurrence of active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants). Alternative therapies (such as thyroid hormone, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered as systemic treatment. 6.The study excluded subjects who were receiving systemic glucocorticoid therapy (excluding nasal, inhalational or other local glucocorticoid routes) or any other form of immunosuppressive therapy within 7 days prior to the first administration; Note: Administration of physiological doses of glucocorticoids (<= 10 mg/day of prednisone or equivalent drugs) is permitted; 7.There are cases of uncontrollable pleural effusion or peritoneal effusion in clinical practice (patients who do not require fluid drainage or who have no significant increase in fluid volume after 3 days of stopped drainage can be included in the study). 8.Known cases of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9.Known allergies to the active ingredients or excipients of the study drugs phenolizumab, carboplatin, or albumin-bound paclitaxel. 10.Before starting the treatment, there was no sufficient recovery from the toxicities and/or complications caused by any intervention (i.e., <= grade 1 or reaching the baseline, excluding fatigue or hair loss); 11.It is known that there is a history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1/2 antibodies). 12.Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected to be greater than the upper limit of normal value in the laboratory of the research center where the test was conducted); Note: Hepatitis B subjects meeting the following criteria can also be enrolled: 1) Before the first administration, the HBV viral load was < 1000 copies/ml (200 IU/ml), and the subject should receive anti-HBV treatment throughout the study treatment period to avoid viral reactivation. 2) For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and negative HBV viral load, no preventive anti-HBV treatment is required, but close monitoring of viral reactivation is necessary. 13.Active HCV-infected subjects (HCV antibody positive and HCV-RNA level above the detection limit); 14.Before the first administration (during the 1st cycle, on the 1st day), 30 days prior to the first administration, one had received an inactivated live vaccine; Note: It is permitted to receive an injectable inactivated virus vaccine for seasonal influenza within 30 days prior to the first administration; However, intranasal attenuated live influenza vaccine is not allowed. 15.Pregnant or lactating women; 16.There are any serious or uncontrollable systemic diseases, such as: 1) Abnormalities in rhythm, conduction or morphology of the resting electrocardiogram that are significant and severe and difficult to control, such as complete left bundle branch block, second-degree or above cardiac conduction block, ventricular arrhythmia or atrial fibrillation; 2) Unstable angina pectoris, congestive heart failure, chronic heart failure with NYHA classification >= 2; 3) Any arterial thrombosis, embolism or ischemia that occurred within 6 months before the inclusion in the treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemic attack; 4) Poor blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 5) History of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or current clinical active interstitial lung disease; 6) Active tuberculosis; 7) Active or uncontrolled infections requiring systemic treatment; 8) Clinical active diverticulitis, abdominal abscess, gastrointestinal obstruction; 9) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 10) Poor diabetes control (fasting blood glucose (FBG) > 10 mmol/L); 11) Urine test indicates urine protein >= ++, and confirmed 24-hour urine protein quantification > 1.0 g; 12) Patients with mental disorders and unable to cooperate with treatment. 17.There may be medical history or disease evidence that interferes with the test results and hinders the full participation of the subjects in the research. There may be abnormal values from treatments or laboratory tests, or other situations that the researcher deems unsuitable for inclusion in the study. The researcher also considers that there are other potential risks that make participation in this study inappropriate.

研究实施时间：

Study execute time：

从 From 2025-12-01 00:00:00至 To 2028-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-12-01 00:00:00 至 To 2026-12-31 00:00:00  

干预措施：

Interventions：

组别：

试验组（单臂试验）

样本量：

35

Group：

Experimental Group

Sample size：

干预措施：

菲诺利单抗联合卡铂、白蛋白结合型紫杉醇

干预措施代码：

Intervention：

Finotonlimab in combination with carboplatin and nab-paclitaxel

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China 

Province：

Guangdong 

City：

 

单位(医院)：

中山大学孙逸仙纪念医院 

单位级别：

三级甲等 

Institution
hospital：

SUN YAT-SEN MEMORIAL HOSPITAL

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

主要病理缓解率

指标类型：

主要指标

Outcome：

Major pathological response rate, MPR

Type：

Primary indicator

测量时间点：

手术结束时

测量方法：

定义为切除标本中的存活肿瘤细胞≤10%的受试者占总受试者的比例，MPR 率=达到 MPR 的受试者例数/总受试者数*100%，采用二项分布计算其 95%CI。

Measure time point of outcome：

At the end of the operation

Measure method：

MPR rate is defined as the proportion of subjects with viable tumor cells <= 10% in the resection specimen among the total subjects. MPR rate = (Number of subjects achieving MPR / Total number of subjects) * 100%, and its 95% CI is calculated using the binomial distribution.

指标中文名：

病理完全缓解率

指标类型：

次要指标

Outcome：

Pathologic Complete Response Rate, PCR

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：

采集的血液（或血液衍生物）

组织：

Sample Name：

ollected blood (or blood derivatives）

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

标本中文名：

基于存档和/或新鲜采集的肿瘤组织

组织：

Sample Name：

Retained or freshly collected tumor tissues

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation 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)：

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：

无

Blinding：

None

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）：

不开放共享

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

Not open for sharing

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：

采用病例报告表（CRF）进行数据采集，储存，并调取分析

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

Data collection, storage and retrieval analysis were carried out using case report forms

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-11-11 17:55:40