ChiCTR2600118276 版本V1.0 版本创建时间2026/02/03 18:26:45 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：

 ChiCTR2600118276 

最近更新日期：

Date of Last Refreshed on：

 2026-02-03 18:26:41 

注册时间：

Date of Registration：

 2026-02-03 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SKB264用于可切除食管癌新辅助治疗的探索性研究

Public title：

An exploratory study on the combination of evoximab and SKB264 for neoadjuvant therapy of resectable esophageal cancer

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SKB264用于可切除食管癌新辅助治疗的探索性研究

Scientific title：

An exploratory study on the combination of evoximab and SKB264 for neoadjuvant therapy of resectable esophageal cancer

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：

徐苗 

研究负责人：

闫小龙 

Applicant：

Miao Xu 

Study leader：

Xiaolong Yan 

申请注册联系人电话：

Applicant telephone：

 +86 151 1480 5811

研究负责人电话：

Study leader's
telephone：

+86 159 9126 9383

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：

 1322738094@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 yanxiaolong@fmmu.edu.cn

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：

西安市灞桥区新寺路569号第四军医大学唐都医院

研究负责人通讯地址：

西安市灞桥区新寺路569号第四军医大学唐都医院

Applicant address：

Tangdu Hospital, Fourth Military Medical University, No. 569, Xinsi Road, Baqiao District, Xi 'an City

Study leader's address：

Tangdu Hospital, Fourth Military Medical University, No. 569, Xinsi Road, Baqiao District, Xi 'an 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：

康方赛诺医药有限公司

Applicant's institution：

Akeso

研究负责人所在单位：

空军军医大学第二附属医院

Affiliation of the Leader：

The Second Affiliated Hospital of Air Force Military 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：

 第202506-21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：

第四军医大学唐都医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Tangdu Hospital, Fourth Military Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-06-19 00:00:00

伦理委员会联系人：

李诗草

Contact Name of the ethic committee：

Shicao Li

伦理委员会联系地址：

西安市灞桥区新寺路569号第四军医大学唐都医院药剂科新办公楼304室

Contact Address of the ethic committee：

Room 304, New Office Building of the Pharmacy Department, Tangdu Hospital, Fourth Military Medical University, No. 569, Xansi Road, Baqiao District, Xi 'an City

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 29 8471 7761

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：

空军军医大学第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Air Force Military Medical University

研究实施负责（组长）单位地址：

西安市灞桥区新寺路569号第四军医大学唐都医院

Primary sponsor's address：

Tangdu Hospital, Fourth Military Medical University, No. 569, Xinsi Road, Baqiao District, Xi 'an 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)：

陕西省

市(区县)：

Country：

China

Province：

Shaanxi Province

City：

单位(医院)：

空军军医大学第二附属医院

具体地址：

西安市灞桥区新寺路569号第四军医大学唐都医院

Institution
hospital：

The Second Affiliated Hospital of Air Force Military Medical University

Address：

Tangdu Hospital, Fourth Military Medical University, No. 569, Xinsi Road, Baqiao District, Xi 'an City

经费或物资来源：

康方赛诺医药有限公司

Source(s) of funding：

Akeso

研究疾病：

食管鳞癌  

Target disease：

ESCC

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：

 其它 

Study phase：

N/A

研究设计：

单臂 

Study design：

Single arm 

研究目的：

初步探索依沃西单抗联合SKB264用于可切除食管癌新辅助治疗的有效性和安全性。  

Objectives of Study：

To preliminarily explore the efficacy and safety of evoximab combined with SKB264 in neoadjuvant therapy for resectable esophageal cancer.

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)患者年龄在18-75岁； 2)患者经组织或细胞学检查，确诊为食管鳞癌； 3)AJCC第八版分期处于II-IVA期（T2-4aNxM0；T2N0M0时，内镜下检查肿瘤长度≥2cm）；肿瘤位于颈段以下且距环咽肌≥5cm，两名高年资胸外科医师一致认为可切除; 4)有完整的影像学检查，未见远处转移； a)颈部超声和胸部/腹部增强CT； b)临床或颈部超声怀疑颈部淋巴结转移时，行超声引导下淋巴结穿刺活检术或PET/CT； c)CT检查怀疑肝转移时，行腹部平扫及增强MRI检查或PET/CT明确诊断； d)如伴有全身疼痛症状，必要时加做骨扫描 e)鼓励超声胃镜明确分期 5)既往未接受过肿瘤疾病相关治疗（包括放化疗、靶向、免疫或中医中药治疗）； 6)生活质量评分依据美国东部肿瘤协作组（Eastern Cooperative Oncology Group, ECOG）制定的活动状态评分表[1]进行评价，纳入ECOG评分0-1的患者； 7)有充足的器官和骨髓功能，满足以下定义：a)血常规（治疗前14天内未行输血、未使用粒细胞集落刺激因子（G-CSF）、未使用其他药物纠正） b)中性粒细胞计数（NE）>1500/μL; c)血红蛋白计数（HGB）>8.0 g/dL; d)血小板计数（PLT）>100 000/μL; e)血生化（肝功能） f)血清肌酐（Cr）≤ 2.5×正常值上限（upper limit of normal，ULN）； g)总胆红素（TBIL）≤ 2.5×ULN； h)谷草转氨酶（AST）或谷丙转氨酶（ALT）水平≤2.5×ULN； 8)经本人同意并签署知情同意书，并遵从计划的访视、研究治疗、实验室检查及其他试验程序。

Inclusion criteria

1)The patient is aged between 18 and 75. 2) The patient was diagnosed with esophageal squamous cell carcinoma through tissue or cytological examination. 3) The AJCC 8th edition staging is at stage II-IVA (T2-4aNxM0; at T2N0M0, the tumor length examined by endoscopy is >= 2cm); The tumor was located below the cervical segment and was >= 5cm away from the cricopharyngeal muscle. Two senior thoracic surgeons unanimously agreed that it was resectable. 4) Complete imaging examinations were conducted, and no distant metastasis was observed. a) Cervical ultrasound and enhanced CT of the chest/abdomen; b) When cervical lymph node metastasis is suspected by clinical or cervical ultrasound, ultrasound-guided lymph node biopsy or PET/CT should be performed. c) When liver metastasis is suspected by CT examination, abdominal plain scan and enhanced MRI examination or PET/CT should be performed for a clear diagnosis. d) If accompanied by systemic pain symptoms, bone scan may be necessary. e) Ultrasound gastroscopy is encouraged to determine the stage. 5) No previous treatment related to tumor diseases (including radiotherapy, chemotherapy, targeted therapy, immunotherapy or traditional Chinese medicine treatment) has been received. 6) The quality of life score was evaluated based on the activity status scoring scale developed by the Eastern Cooperative Oncology Group (ECOG) [1], and patients with an ECOG score of 0-1 were included; 7) There is sufficient organ and bone marrow function, meeting the following definitions: a) blood routine test (no blood transfusion, no use of granulocyte colony-stimulating factor (G-CSF), and no correction with other drugs within 14 days before treatment) b) Neutrophil count (NE) >1500/μL; c) Hemoglobin count (HGB) >8.0 g/dL; d) Platelet count (PLT) > 100,000 /μL; e) Blood biochemistry (liver function) f) Serum creatinine (Cr) <= 2.5× upper limit of normal (ULN); g) Total bilirubin (TBIL) <= 2.5×ULN; h) The level of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is <= 2.5×ULN; 8) With my consent and the signing of the informed consent form, and in compliance with the planned visit, research treatment, laboratory tests and other experimental procedures.

排除标准：

1)治疗前四周内接受过以下医疗干预的患者： 2)针对肿瘤的手术、放疗、化疗、免疫或分子靶向治疗； 3)参与其他临床研究的药物治疗； 4)减毒活疫苗接种史。 5)既往接受过抗程序性死亡分子（Programmed death-1, PD-1）/PD-1配体（PD-1 ligand, PD-L1）单抗，细胞毒淋巴细胞相关抗原4（cytotoxic T lymphocyte-associated antigen-4,CTLA-4）抗体或其他免疫或分子靶向治疗。 6)有计划在研究期间进行针对食管鳞癌的放疗治疗； 7)经影像学诊断，有肿瘤远处转移； ?颈部超声和胸部/腹部增强CT提示有其他脏器转移的； ?经PET/CT或MRI证实有其他脏器转移的； 8)食管鳞癌合并间质性肺炎或肺纤维化的患者； 9)开始治疗前7天之内既往使用过免疫抑制药物、糖皮质激素； 10)存在任何活动性自身免疫病或有自身免疫病病史（包括但不局限于：自身免疫性肝炎、间质性肺炎，葡萄膜炎、肠炎、肝炎、垂体炎、血管炎、肾炎、甲状腺功能亢进、甲状腺功能降低），或已知异体器官移植史或异体造血干细胞移植史； 11)治疗前4周出现活动性感染（如需要静脉滴注抗生素、抗真菌或抗病毒药物），或在筛选期间/首次给药前出现不明原因的发热>38.5°C； 12)治疗前曾诊断为任何其他恶性肿瘤。 13)已知对研究药物或其任何辅料过敏，或者对其他单克隆抗体发生过严重过敏反应。 14)妊娠期或哺乳期妇女及育龄妇女未采取可靠避孕措施。 根据研究者的判断，存在严重危害受试者安全、可能混淆研究结果、或影响受试者完成本研究的伴随疾病（如控制不佳的高血压、控制不佳的糖尿病、控制不佳的神经或精神疾病等）或其他任何情况。

Exclusion criteria：

1)Patients who have received the following medical interventions within four weeks before treatment: 2) Surgery, radiotherapy, chemotherapy, immunotherapy or molecular targeted therapy for tumors; 3) Participate in drug treatment in other clinical studies; 4) History of vaccination with attenuated live vaccines. 5) Previously received anti-programmed death-1 (PD-1) /PD-1 ligand (PD-L1) monoclonal antibody cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies or other immunotherapy or molecular targeted therapy. 6) There is a plan to carry out radiotherapy treatment for esophageal squamous cell carcinoma during the research period; 7) As diagnosed by imaging, there is distant metastasis of the tumor. Cervical ultrasound and enhanced CT of the chest/abdomen suggest metastasis to other organs; Metastasis to other organs confirmed by PET/CT or MRI; 8) Patients with esophageal squamous cell carcinoma complicated with interstitial pneumonia or pulmonary fibrosis; 9) Immunosuppressive drugs or glucocorticoids have been used in the past within 7 days before the start of treatment; 10) There is any active autoimmune disease or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 11) Active infection occurred 4 weeks before treatment (such as requiring intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever >38.5°C occurred during screening/before the first administration; 12) Had been diagnosed with any other malignant tumor before treatment. 13) Known to have been allergic to the research drug or any of its excipients, or had a severe allergic reaction to other monoclonal antibodies. 14) Pregnant or lactating women and women of childbearing age have not taken reliable contraceptive measures. According to the researchers' judgment, there are concomitant diseases (such as poorly controlled hypertension, poorly controlled diabetes, poorly controlled neurological or mental disorders, etc.) or any other conditions that seriously endanger the safety of the subjects, may confuse the research results, or affect the subjects' completion of this study.

研究实施时间：

Study execute time：

从 From 2026-02-12 00:00:00至 To 2028-02-12 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-02-12 00:00:00 至 To 2026-08-12 00:00:00

干预措施：

Interventions：

组别：

实验组

样本量：

 30

Group：

Experimental Group

Sample size：

干预措施：

术前新辅助治疗药物为依沃西单抗+SKB264，术前治疗2个周期，3周为一个周期。每个治疗周期的第 1 天静脉给药依沃西单抗注射液10mg/kg，随后静脉给药SKB264 5mg/kg。术后经研究者评估，需要进行辅助治疗的受试者，进行为期1年的辅助治疗，治疗方案同新辅助。

干预措施代码：

Intervention：

The neoadjuvant treatment drug before the operation was evoximab +SKB264. The preoperative treatment lasted for 2 cycles, with 3 weeks as one cycle. On the first day of each treatment cycle, ivosimab injection at a dose of 10mg/kg was intravenously administered, followed by SKB264 at a dose of 5mg/kg intravenously. After the operation, the subjects who needed adjuvant therapy were evaluated by the researchers and received adjuvant therapy for one year. The treatment plan was the same as that of neoadjuvant therapy.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 陕西省 

市(区县)：

  

Country：

China

Province：

Shaanxi Province

City：

单位(医院)：

 空军军医大学第二附属医院 

单位级别：

 三甲 

Institution
hospital：

The Second Affiliated Hospital of Air Force Military Medical University

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：

MPR

Type：

Primary 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：

血液及肿瘤组织

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 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)：

None

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

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）：

无

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：

edc系统

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

edc

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：

  2026-02-03 18:26:41