ChiCTR2600125677 版本V1.0 版本创建时间2026/05/29 11:05:58 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：

ChiCTR2600125677 

最近更新日期：

Date of Last Refreshed on：

2026-05-29 11:05:51 

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：

新辅助化疗不敏感三阴性乳腺癌联合特瑞普利单抗+放疗的II期单臂临床研究

Public title：

Phase II Single-Arm Clinical Study of Toripalimab Combined with Radiotherapy in Triple-Negative Breast Cancer Insensitive to Neoadjuvant Chemotherapy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

新辅助化疗不敏感三阴性乳腺癌联合特瑞普利单抗+放疗的II期单臂临床研究

Scientific title：

Phase II Single-Arm Clinical Study of Toripalimab Combined with Radiotherapy in Triple-Negative Breast Cancer Insensitive to Neoadjuvant Chemotherapy

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：

邵青 

研究负责人：

曾晓华 

Applicant：

Qing Shao  

Study leader：

Xiaohua Zeng 

申请注册联系人电话：

Applicant telephone：

+86 158 2318 0603

研究负责人电话：

Study leader's telephone：

+86 158 2318 0603

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：

810806925@qq.com

研究负责人电子邮件：

Study leader's E-mail：

810806925@qq.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：

重庆市沙坪坝区汉渝路 181 号

研究负责人通讯地址：

重庆市沙坪坝区汉渝路 181 号

Applicant address：

No. 181 Hanyu Road, Shapingba District, Chongqing, China

Study leader's address：

No. 181 Hanyu Road, Shapingba District, Chongqing, China

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：

重庆大学附属肿瘤医院

Applicant's institution：

Chongqing University Cancer Hospital

研究负责人所在单位：

重庆大学附属肿瘤医院

Affiliation of the Leader：

Chongqing University 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：

CZLL 2025-076-001

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：

重庆大学附属肿瘤医院伦理委员会

Name of the ethic committee：

Ethics Committee of Chongqing University Cancer Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025-09-22 00:00:00

伦理委员会联系人：

汤晓华

Contact Name of the ethic committee：

Xiaohua Tang

伦理委员会联系地址：

中国重庆市沙坪坝区汉渝路 181 号

Contact Address of the ethic committee：

No. 181 Hanyu Road, Shapingba District, Chongqing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 23 6507 5695

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：

重庆大学附属肿瘤医院

Primary sponsor：

Chongqing University Cancer Hospital

研究实施负责（组长）单位地址：

中国重庆市沙坪坝区汉渝路 181 号

Primary sponsor's address：

No. 181 Hanyu Road, Shapingba District, Chongqing, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

重庆

市(区县)：

Country：

China

Province：

Chongqing

City：

单位(医院)：

重庆大学附属肿瘤医院

具体地址：

中国重庆市沙坪坝区汉渝路 181 号

Institution
hospital：

Chongqing University Cancer Hospital

Address：

No. 181 Hanyu Road, Shapingba District, Chongqing, China

经费或物资来源：

无

Source(s) of funding：

None

Target disease：

Breast cancer

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：

初步探索化疗联合特瑞普利单抗+低剂量及立体定向放疗新辅助治疗经新辅助化疗2周期后不敏感的IIB期或III期三阴性乳腺癌的有效性和安全性，探寻三阴性乳腺癌患者中对单纯新辅助化疗不敏感人群的有效新辅助治疗手段，寻找潜在的疗效预测因素，协助早期识别获益人群，若该方案有效，将为下一步开展III期随机对照研究以及开展多中心的临床试验奠定基础。  

Objectives of Study：

To preliminarily explore the efficacy and safety of neoadjuvant therapy combining chemotherapy with toripalimab plus low-dose radiotherapy and stereotactic radiotherapy in patients with stage IIB or III triple-negative breast cancer who are insensitive after 2 cycles of neoadjuvant chemotherapy; to explore effective neoadjuvant treatment strategies for triple-negative breast cancer patients with insensitivity to neoadjuvant chemotherapy alone; to identify potential predictive factors of therapeutic response and assist in the early recognition of benefit populations. If this regimen is proven effective, it will lay a foundation for the subsequent conduct of phase III randomized controlled trials and multicenter clinical trials.

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)受试者或其法定代理人自愿书面签署知情同意书； (2)年龄为18~75周岁（包含上下限），女性； (3)经细胞学或组织学诊断为三阴性乳腺癌； (4)根据RECIST1 .1 标准，至少有一个可测量的靶病灶； (5)初诊的IIB期或III期乳腺癌，经EC方案新辅助化疗2程后，即拟行第3周期治疗前1天，依据RECIST1 .1 标准，疗效评价SD/PD的患者； (6)计划接受乳腺癌的最终手术切除； (7)ECOG 功能状态评分0~1 分； (8)具有充分的器官和骨髓功能； (9)对未绝经或未行手术绝育的女性患者：在治疗期间和研究治疗中最后一次给药后至少7 个月内，同意禁欲或使用有效的避孕方法。育龄期女性接受过外科绝育术(包括子宫切除术，双侧卵巢切除术或子宫全切术)、或已经绝经（定义为无医学原因连续12 个月以上没有月经），即视为没有怀孕的可能性。

Inclusion criteria

(1) The subject or their legal representative voluntarily signs the written informed consent form. (2) Female patients aged 18 to 75 years (inclusive). (3) Diagnosed with triple-negative breast cancer by cytological or histological examination. (4) Having at least one measurable target lesion according to the RECIST 1.1 criteria. (5) Patients with newly diagnosed stage IIB or III breast cancer, who are evaluated as stable disease (SD) or progressive disease (PD) per RECIST 1.1 criteria on the day before the planned third cycle of treatment after receiving 2 cycles of neoadjuvant chemotherapy with the EC regimen. (6) Planned to undergo definitive surgical resection for breast cancer. (7) Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. (8) With adequate organ and bone marrow function. (9) For premenopausal females or those without surgical sterilization: agree to abstain from sexual intercourse or adopt effective contraceptive measures during the treatment period and for at least 7 months after the last dose of study treatment. Women of childbearing potential who have undergone surgical sterilization (including hysterectomy, bilateral oophorectomy or total hysterectomy) or are postmenopausal (defined as absence of menses for at least 12 consecutive months without medical cause) will be considered to have no potential for pregnancy.

排除标准：

(1)双侧乳腺癌、多中心乳腺癌、炎性乳腺癌、存在远处转移的乳腺癌患者； (2)既往接受过内分泌治疗、免疫治疗、靶向治疗、放疗等除新辅助化疗外任何抗肿瘤治疗的患者，或接受过乳腺手术的乳腺癌患者（原发性乳腺癌的诊断活检除外）； (3)既往高血压危象或高血压脑病病史；存在药物未能控制的高血压(收缩压＞140 mmHg 和/或舒张压＞90 mmHg)； (4)入组前6 个月内的动脉血栓、深静脉血栓病史：如肺栓塞、脑梗死、短暂性脑缺血发作、心肌梗死等，但不需要治疗的导管相关附壁血栓可以入组； (5)显著的血管疾病（包括但不限于需要手术修复的主动脉瘤或近期动脉血栓形成）、不稳定型心绞痛、纽约心脏病协会(NYHA)分类≥Ⅲ级的心功能不全、药物无法控制的严重心律失常； (6)入组前4 周内有重大手术、重大外伤史；不管严重程度如何，存在任何出血体质迹象或病史的受试者；在首次给药前4 周内，出现任何出血或流血事件≥CTCAE 3 级的受试者；或存在未愈合创口、骨折、胃及十二指肠活动性溃疡、溃疡性结肠炎等消化道疾病或未切除的肿瘤存在活动出血，或研究者判定的可能引起消化道出血、穿孔的其他状况； (7)存在任何活动性自身免疫病或有自身免疫病病史且预期复发(如系统性红斑狼疮、类风湿性关节炎、炎症性肠病、多发性硬化、垂体炎、血管炎等)；但不包括以下疾病：经固定剂量胰岛素治疗病情稳定的Ⅰ型糖尿病；只需接受激素替代治疗或无需进行治疗的甲状腺功能减退症；无需进行全身治疗的皮肤疾病(如湿疹，占体表10%以下的皮疹，无眼科症状的银屑病等)； (8)有明确临床诊断为间质性肺炎，肺纤维化，药物性肺炎病史或3月内胸部CT 检查发现有需要治疗的活动性肺炎的证据；患有活动性肺结核(TB)的患者，正在接受抗结核治疗或者筛选前1 年内接受过抗结核治疗； (9)不能控制的需要反复引流的胸腔积液、心包积液或腹水； (10)人类免疫缺陷病毒（HIV）感染或已知有获得性免疫缺陷综合征（艾滋病），活动性乙型肝炎（HBV DNA ≥1000 IU/ml），丙型肝炎（丙肝抗体阳性，且HCV-RNA 高于分析方法的检测下限）或合并乙肝和丙肝共同感染； (11)妊娠期或哺乳期女性受试者；不愿或不能在本试验的整个治疗期间及试验用药品末次给药后7个月内采用可接受的方法进行避孕的育龄妇女（育龄妇女包括：任何有过月经初潮，以及未接受过成功的人工绝育手术[子宫切除术、双侧输卵管结扎、或双侧卵巢切除术]或未绝经）或男性受试者； (12)任何精神或认知障碍，可能会限制其对知情同意书的理解、执行； (13)研究者认为不适合参与本试验的其他情况，如依从性差等。

Exclusion criteria：

(1) Patients with bilateral breast cancer, multicentric breast cancer, inflammatory breast cancer, or breast cancer with distant metastasis. (2) Patients who have previously received any antitumor therapy other than neoadjuvant chemotherapy, including endocrine therapy, immunotherapy, targeted therapy and radiotherapy; or patients who have undergone breast surgery (excluding diagnostic biopsy for primary breast cancer). (3) History of hypertensive crisis or hypertensive encephalopathy; uncontrolled hypertension despite medication (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg). (4) History of arterial thrombosis or deep vein thrombosis within 6 months prior to enrollment, such as pulmonary embolism, cerebral infarction, transient ischemic attack, myocardial infarction, etc. Patients with catheter-related mural thrombosis that requires no treatment are eligible for enrollment. (5) Patients with significant vascular diseases (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis), unstable angina pectoris, cardiac insufficiency classified as New York Heart Association (NYHA) Class Ⅲ or above, or severe arrhythmia uncontrolled by medications. (6) Patients with a history of major surgery or severe trauma within 4 weeks prior to enrollment; subjects with any evidence or history of bleeding diathesis regardless of severity; subjects with any bleeding event >= CTCAE Grade 3 within 4 weeks before the first study drug administration; subjects with unhealed wounds, fractures, active gastroduodenal ulcer, ulcerative colitis or other gastrointestinal diseases, unresected tumors with active bleeding, or any other conditions judged by the investigator to be likely to cause gastrointestinal bleeding or perforation. (7) Patients with any active autoimmune disease, or a history of autoimmune disease with expected recurrence (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, hypophysitis, vasculitis, etc.). The following conditions are not excluded: Type 1 diabetes well-controlled with fixed-dose insulin; hypothyroidism managed with hormone replacement therapy or requiring no treatment; skin diseases without the need for systemic therapy (e.g., eczema, rash involving less than 10% of body surface area, psoriasis without ocular manifestations). (8) Patients with a confirmed clinical diagnosis of interstitial lung disease, pulmonary fibrosis or drug-induced pneumonitis, or evidence of active pneumonia requiring treatment detected on chest CT within the past 3 months; patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis therapy within 1 year prior to screening. (9) Uncontrolled pleural effusion, pericardial effusion or ascites that requires repeated drainage. (10) Patients with human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis B (HBV DNA >= 1000 IU/mL); hepatitis C infection (positive anti-HCV antibody with HCV-RNA level above the lower limit of assay detection); or co-infection with hepatitis B and hepatitis C. (11) Pregnant or lactating female subjects; women of childbearing potential or male subjects who are unwilling or unable to use acceptable contraceptive methods throughout the study treatment period and for 7 months after the last dose of investigational product. Women of childbearing potential are defined as those who have experienced menarche, and have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) and are not postmenopausal. (12) Any psychiatric or cognitive disorder that may impair the subject’s understanding and compliance with the informed consent procedure. (13) Any other conditions deemed inappropriate for study participation by the investigator, such as poor treatment compliance.

研究实施时间：

Study execute time：

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

试验组

样本量：

36

Group：

Experimental Group

Sample size：

干预措施：

TCb+特瑞普利单抗+放疗

干预措施代码：

Intervention：

TCb + Toripalimab + Radiotherapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 重庆 

市(区县)：

  

Country：

China 

Province：

Chongqing 

City：

 

单位(医院)：

重庆大学附属肿瘤医院 

单位级别：

三甲 

Institution
hospital：

Chongqing University Cancer Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

病理完全缓解率

指标类型：

主要指标

Outcome：

Pathological Complete Response

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

客观缓解率

指标类型：

次要指标

Outcome：

Objective Response 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：

无事件生存期

指标类型：

次要指标

Outcome：

Event-Free 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：

血液

组织：

乳腺

Sample Name：

Blood

Tissue：

Breast

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：

女性

Gender：

Female

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

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：

病例记录表和医院电子采集和管理系统。为保证研究全过程受试者安全和数据准确、完整和可靠，研究者在患者档案中实验室检查报告、临床记录以及患者病历，作为研究原始文件。如有需要，研究者允许申办者、有关监督部门和相应伦理审查委员会(ERB)直接调阅原始文件。

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

Case Report Form (CRF) and hospital electronic data collection and management system. To ensure subject safety throughout the study as well as the accuracy, integrity and reliability of study data, the investigator shall retain laboratory test reports, clinical records and medical charts in the patient’s file as the source documents of the study. When necessary, the investigator shall permit the sponsor, relevant regulatory authorities and the corresponding Ethical Review Board (ERB) to directly inspect the source documents.

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：

  2026-05-29 11:05:51