ChiCTR2600125653 版本V1.0 版本创建时间2026/05/29 09:54:20 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：

 ChiCTR2600125653 

最近更新日期：

Date of Last Refreshed on：

 2026-05-29 09:54:14 

注册时间：

Date of Registration：

 2026-05-29 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

安罗替尼联合贝莫苏拜单抗用于可切除食管鳞癌新辅助治疗的有效性及安全性临床研究

Public title：

Clinical trial on the efficacy and safety of anlotinib combined with bemocizumab for neoadjuvant therapy of resectable esophageal squamous cell carcinoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

安罗替尼联合贝莫苏拜单抗用于可切除食管鳞癌新辅助治疗的有效性及安全性临床研究

Scientific title：

Clinical trial on the efficacy and safety of anlotinib combined with bemocizumab for neoadjuvant therapy of resectable esophageal 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：

饶旭光 

研究负责人：

饶旭光 

Applicant：

Xuguang Rao 

Study leader：

Xuguang Rao 

申请注册联系人电话：

Applicant telephone：

 +86 20 6278 7726

研究负责人电话：

Study leader's
telephone：

+86 20 6278 7726

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：

 347901213@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 raoxuguang1971@126.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：

广东省广州市白云区广州大道北1838号

研究负责人通讯地址：

广州大道北1838号

Applicant address：

No. 1838, Guangzhou Avenue North, Baiyun District, Guangzhou City, Guangdong Province

Study leader's address：

1838 North Guangzhou Avenue

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：

南方医科大学南方医院

Applicant's institution：

Nanfang Hospital, Southern Medical University

研究负责人所在单位：

南方医科大学南方医院

Affiliation of the Leader：

Southern Medical University Southern Hospital

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：

 NFEC-2026-220

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：

南方医科大学南方医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Nanfang Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-02 00:00:00

伦理委员会联系人：

胡兴媛

Contact Name of the ethic committee：

Hu XingYuan

伦理委员会联系地址：

广州大道北1838号

Contact Address of the ethic committee：

1838 North Guangzhou Avenue

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 6278 7238

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 nfyyec@163.com

研究实施负责（组长）单位：

南方医科大学南方医院

Primary sponsor：

Southern Medical University Southern Hospital

研究实施负责（组长）单位地址：

广州大道北1838号

Primary sponsor's address：

1838 North Guangzhou Avenue

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)：

南方医科大学南方医院

具体地址：

广州大道北1838号

Institution
hospital：

Southern Medical University Southern Hospital

Address：

1838 North Guangzhou Avenue

经费或物资来源：

正大天晴药业集团股份有限公司

Source(s) of funding：

NONE

研究疾病：

食管鳞状细胞癌  

Target disease：

Esophageal 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：

 其它 

Study phase：

N/A

研究设计：

单臂 

Study design：

Single arm 

研究目的：

本研究旨在探索安罗替尼联合贝莫苏拜单抗用于可切除食管鳞癌新辅助治疗的有效性和安全性，以期提高食管癌手术患者的病理完全缓解率pCR率、R0切除率，并提高食管癌术后患者的无病生存期（DFS），为局部晚期食管癌患者治疗提供指导及新选择。  

Objectives of Study：

This study aims to explore the efficacy and safety of anlotinib combined with bemocizumab as neoadjuvant therapy for resectable esophageal squamous cell carcinoma, with the goal of improving the pathological complete response (pCR) rate and R0 resection rate in patients undergoing esophageal cancer surgery, as well as enhancing disease-free survival (DFS) in postoperative patients. This will provide guidance and new options for the treatment of patients with locally advanced 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.年龄18-70岁，男女均可；
2.经胃镜/超声胃镜活检，病理提示为食管鳞状细胞癌，且临床诊断为cT2N1-2M0或cT3N0-2M0，TNM分期为II-ⅢB 期；
3.非颈段食管癌患者；
4.既往未接受过针对食管癌的全身和局部治疗，根据RECIST 1.1标准至少有一个可测量病灶用于新辅助治疗影像学评价；
5.ECOG PS：0-1分；
6.预计生存期≥12个月；
7.受试者无主要器官的功能障碍，研究者评估甲状腺、肺、肝、肾功能及心脏功能基本正常；
8.育龄妇女必须已经采取可靠的避孕措施或在入组前7天内进行妊娠试验（血清或尿液），且结果为阴性，并且愿意在试验期间和末次给予试验药物后8周采用适当的方法避孕。对于男性，须同意在试验期间和末次给予试验药物后8周采用适当的方法避孕或已手术绝育；
9.受试者自愿加入本研究，并签署知情同意书，依从性好，遵循计划的日程积极配合回到医院进行规律的临床随访及必要的治疗，配合定期血液和组织样本获取；

Inclusion criteria

1.Aged 18-70, both male and female;
2.After gastroscopy/ultrasonic gastroscopy biopsy, the pathology suggests squamous cell carcinoma of the esophagus, and the clinical diagnosis is cT2N1-2M0 or cT3N0-2M0, with TNM staging of II-III B;
3.Patients with non-cervical esophageal cance;
4.The patient has not previously received systemic or local treatment for esophageal cancer, and according to the RECIST 1.1 criteria, there is at least one measurable lesion for imaging evaluation of neoadjuvant therapy;
5.ECOG PS: 0-1;
6.Expected survival duration ≥ 12 months;
7.The subjects had no functional disorders of major organs, and the researchers assessed that thyroid, lung, liver, kidney, and heart functions were basically normal;
8.Women of childbearing age must have already taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and be willing to use appropriate contraception during the trial and for 8 weeks after the last administration of the trial medication. For males, they must agree to use appropriate contraception during the trial and for 8 weeks after the last administration of the trial medication, or have undergone surgical sterilization;
9.The subjects voluntarily joined this study, signed the informed consent form, exhibited good compliance, actively cooperated with the planned schedule by returning to the hospital for regular clinical follow-ups and necessary treatments, and cooperated with the regular collection of blood and tissue samples;

排除标准：

1. 5年内出现过或当前同时患有其它恶性肿瘤，治愈的子宫颈原位癌、非黑色素瘤的皮肤癌和表浅的膀胱肿瘤除外 [Ta (非浸润性肿瘤)，Tis (原位癌) 和T1 (肿瘤浸润基膜)]； 2. 溃疡型的食管鳞癌患者； 3. 食管瘘或气管瘘患者； 4. 对安罗替尼、贝莫苏拜单抗过敏者； 5. 有免疫缺陷病史，包括HIV阳性或患有其它获得性、先天性免疫缺陷疾病，或有器官移植史者； 6. 存在任何重度和/或未能控制的疾病的患者； 7. 由于任何既往治疗引起的高于CTC AE 1级以上的未缓解的毒性反应，不包括脱发； 8. 具有影响口服药物的多种因素（比如无法吞咽、慢性腹泻和肠梗阻等）者； 9. 尿常规提示尿蛋白>=++，且证实24小时尿蛋白定量>1.0 g者； 10. 分组前28天内接受了重大外科治疗、切开活检或明显创伤性损伤； 11. 凝血功能异常：INR>1.5或凝血酶原时间（PT）>ULN+4秒或APTT>1.5ULN，具有出血倾向或正在接受溶栓或抗凝治疗；在分组前4周内，出现任何出血或流血事件>=CTCAE 3级的患者，存在未愈合创口、溃疡或骨折； 12. 6个月内发生过动/静脉血栓事件，如脑血管意外（包括暂时性缺血性发作）、深静脉血栓及肺栓塞者； 13. 怀孕或哺乳期妇女； 14. 出现远处转移者； 15. 有明显骨髓抑制患者； 16. 有精神疾病，或者精神类药物滥用史； 17. 4周内参加过其他药物临床试验的患者； 18. 根据研究者的判断，有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； 19. 有遗传性出血倾向、凝血功能障碍、潜在侵犯大血管及其他出血风险，入组前3个月内出现过有临床意义的出血症状或具有明确的出血倾向，如消化道出血、出血性胃溃疡、基线期大便潜血++及以上； 20. 研究者认为不适合纳入者。

Exclusion criteria：

1.Within the past 5 years, there has been or is currently a co-occurrence of other malignant tumors, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invades the basement membrane)];
2.Patients with ulcerative esophageal squamous cell carcinoma;
3.Patients with esophageal fistula or tracheal fistula;
4.Those who are allergic to anlotinib and bemusuban;
5.Those with a history of immune deficiency, including HIV-positive or suffering from other acquired or congenital immune deficiency diseases, or those who have undergone organ transplantation;
6.Patients with any severe and/or uncontrolled diseases;
7.Unresolved toxic reactions above CTC AE Grade 1 caused by any previous treatment, excluding alopecia;
8.Individuals with multiple factors affecting oral medication administration, such as inability to swallow, chronic diarrhea, and intestinal obstruction;
9.Urine routine test indicates proteinuria ≥++ and confirmed 24-hour urine protein quantitation > 1.0 g;
10.Subjects who underwent major surgical procedures, incisional biopsies, or significant traumatic injuries within 28 days prior to grouping;
11.Abnormal coagulation function: INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5ULN), with a tendency to bleed or undergoing thrombolytic or anticoagulant therapy; patients who have experienced any bleeding or hemorrhagic events ≥ CTCAE Grade 3 within 4 weeks before grouping, have unhealed wounds, ulcers, or fractures;
12.Those who have experienced arterial or venous thromboembolic events within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism;
13.Pregnant or lactating women;
14.Patients with distant metastasis;
15.Patients with significant bone marrow suppression;
16.Suffering from mental illness or having a history of abuse of psychotropic drugs;
17.Patients who have participated in other drug clinical trials within 4 weeks;
18.Patients with concomitant diseases that, according to the researcher's judgment, pose serious risks to patient safety or affect patients' ability to complete the study;
19.Individuals with hereditary bleeding tendency, coagulation dysfunction, potential invasion of large blood vessels, and other bleeding risks, who have experienced clinically significant bleeding symptoms or have a clear tendency to bleed within the previous 3 months before enrollment, such as gastrointestinal bleeding, bleeding gastric ulcer, and baseline fecal occult blood test result of ++ or above;
20.Researchers consider those who are not suitable for inclusion;

研究实施时间：

Study execute time：

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

征募观察对象时间：

Recruiting time：

从 From 2026-06-01 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：

治疗组

样本量：

 25

Group：

Treatment group

Sample size：

干预措施：

术前接受新辅助治疗3-4周期，具体方案为：贝莫苏拜单抗，1200mg q3w；安罗替尼，8mg qd d1-d14

干预措施代码：

Intervention：

Received neoadjuvant therapy for 3-4 cycles before surgery, with the specific regimen as follows: bevacizumab, 1200mg q3w; anlotinib, 8mg qd d1-d14

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)：

 南方医科大学南方医院 

单位级别：

 三级甲等 

Institution
hospital：

Southern Medical University Southern Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

总生存时间

指标类型：

次要指标

Outcome：

OS

Type：

Secondary indicator

测量时间点：

从患者被随机分配至治疗组或对照组（即随机化分组）开始，直至因任何原因死亡的时间；若患者存活，则以最后一次确认存活的随访时间作为截止点

测量方法：

采用Kaplan-Meier法进行生存分析，计算中位OS时间

Measure time point of outcome：

The duration starts from the time when the patient is randomly assigned to the treatment group or co

Measure method：

The Kaplan-Meier method was used for survival analysis to calculate the median overall survival (OS) time

指标中文名：

R0切除率

指标类型：

次要指标

Outcome：

Resection with no residual

Type：

Secondary indicator

测量时间点：

术后

测量方法：

统计在一组接受肿瘤手术的患者中，达到R0切除（即显微镜下切缘无癌细胞残留）的患者所占的比例，计算公式为：R0切除数 ÷ 总手术患者数 × 100%

Measure time point of outcome：

postoperative

Measure method：

Calculate the proportion of patients who achieved R0 resection (i.e., no residual cancer cells at the resection margin under the microscope) among a group of patients who underwent tumor surgery. The calculation formula is: R0 resection cases ÷ total number of surgical patients × 100%

指标中文名：

病理完全缓解率

指标类型：

主要指标

Outcome：

PCR

Type：

Primary indicator

测量时间点：

术后病理

测量方法：

病理完全缓解率（pCR率）的测量方法是通过手术切除后的病理学检查，确认原发灶和区域淋巴结中无任何存活肿瘤细胞，以此作为“1”，未达到则为“0”，最终以达到pCR的患者数占总患者数的百分比来计算? 。

Measure time point of outcome：

Postoperative pathology

Measure method：

The measurement method for pathological complete response rate (pCR rate) involves pathological examination after surgical resection to confirm the absence of any viable tumor cells in the primary lesion and regional lymph nodes, which is denoted as "1". If this criterion is not met, it is denoted as "0". The final calculation is based on the percentage of patients achieving pCR out of the total number of patients.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 70 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

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：

病例记录表

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

Case Record Form, CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-05-29 09:54:14