中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2200067005
最近更新日期： Date of Last Refreshed on：	2025-05-07 17:02:09
注册时间： Date of Registration：	2022-12-23 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	评价卡度尼利单抗联合化疗在三阴性乳腺癌新辅助治疗中的疗效及安全性的临床研究
Public title：	Efficacy and safety of Cadonilimab combined with chemotherapy in neoadjuvant therapy for triple-negative breast cancer
注册题目简写：
English Acronym：
研究课题的正式科学名称：	评价卡度尼利单抗联合化疗在三阴性乳腺癌新辅助治疗中的疗效及安全性的临床研究
Scientific title：	Efficacy and safety of Cadonilimab combined with chemotherapy in neoadjuvant therapy for triple-negative breast 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：	陈子琴	研究负责人：	吴涛
Applicant：	Chen Ziqin	Study leader：	Wu Tao
申请注册联系人电话： Applicant telephone：	+86 133 9766 1720	研究负责人电话： Study leader's telephone：	+86 158 7364 4000
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：	chenziqin1001@126.com	研究负责人电子邮件： Study leader's E-mail：	20689452@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：	湖南省常德市人民路818号	研究负责人通讯地址：	湖南省常德市人民路818号
Applicant address：	818 Renmin Road, Changde, Hu'nan	Study leader's address：	818 Renmin Road, Changde, Hu'nan
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：	常德市第一人民医院
Applicant's institution：	Changde First People's Hospital
研究负责人所在单位：	常德市第一人民医院
Affiliation of the Leader：	Changde First People's 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：	2022-253-01	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：	常德市第一人民医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Changde First People's Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2022-11-28 00:00:00
伦理委员会联系人：	周述香
Contact Name of the ethic committee：	Zhou Shuxiang
伦理委员会联系地址：	湖南省常德市人民路818号
Contact Address of the ethic committee：	818 Renmin Road, Changde, Hu'nan
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 137 8787 5628	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：

常德市第一人民医院

Primary sponsor：

Changde First People's Hospital

研究实施负责（组长）单位地址：

湖南省常德市人民路818号

Primary sponsor's address：

818 Renmin Road, Changde, Hu'nan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	湖南	市(区县)：	常德
Country：	China	Province：	Hunan	City：	Changde
单位(医院)：	常德市第一人民医院	具体地址：	湖南省常德市人民路818号
Institution hospital：	Changde First People's Hospital	Address：	818 Renmin Road, Changde, Hu'nan

经费或物资来源：

中山康方生物医药有限公司

Source(s) of funding：

Zhongshan Kangfang Biomedical Co. LTD

研究疾病：

三阴性乳腺癌

Target disease：

Triple Negative Breast Cancer

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：

II期临床试验

Study phase：

2

研究设计：

单臂

Study design：

Single arm

研究目的：

评价卡度尼利单抗联合化疗在三阴性乳腺癌新辅助治疗中的有效性和安全性。

Objectives of Study：

To evaluate the efficacy and safety of cardonilizumab combined with chemotherapy in neoadjuvant therapy for triple negative breast 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：

Inclusion criteria

1. Subjects voluntarily enrolled in the study, signed an informed consent form, and were compliant;
2. Age: 18-75 years (at the time of signing the informed consent form); ECOG PS score: 0-1; expected survival more than 6 months;
3. Patients with primary breast cancer confirmed by pathologic histology or cytology;
4. Laboratory tests confirm the diagnosis as HER2 negative;
Note: Definition of HER-2 negative: immunohistochemistry results of 0, 1+, 2+ and FISH double probe negative (2018 edition of ASCO/CAP HER2 testing guidelines);
5. Confirm that both estrogen receptor [ER] and progesterone receptor [PgR] are negative;
6. The patient agrees to undergo mastectomy for breast cancer when surgical criteria are met after neoadjuvant therapy;
7. Invasive breast cancer that, in the judgment of the investigator, meets the American Joint Committee on Cancer AJCC 8th edition TNM staging for breast cancer, stage IA-IIIC (T1c-T4 plus any N, M0) and histologically confirmed invasive breast cancer; patients with invasive breast cancer must have a solid lesion capable of coarse needle aspiration biopsy.
8. Major organs are functioning well and meet the following criteria:
(1) Criteria for routine blood tests (no blood transfusion or correction with hematopoietic-stimulating factor analogs within 7 days prior to screening):
1) Hemoglobin (HGB) >= 90 g/L;
2) Absolute neutrophil value (NEUT) >=1.5 x 10^9 /L;
3) Platelet count (PLT) >= 100 x 10^9 /L;
4) Leukocytes >= 2.5 x 10^9 /L.
(2) Biochemical tests need to meet the following criteria:
1) Total bilirubin (TBIL) <= 1.5 times the upper limit of normal (ULN);
2) Alanine-based transferase (ALT) and aspartate-based transferase (AST) <= 1.5 x ULN;
3) Serum creatinine (CR) <= 1.5 x ULN or creatinine clearance (CCR) >= 50 ml/min.
(3) Coagulation tests need to meet the following criteria:
1) Prothrombin time (PT), activated partial thromboplastin time (APTT), and International Normalized Ratio (INR) ≤ 1.5 x ULN (no anticoagulant therapy) if the patient is on anticoagulant therapy as long as the PT is within the range of anticoagulant medication proposed to be used;
9. For women who are not menopausal (menopause defined as non-treatment-induced menopause ≥ 12 months) or who are not surgically sterilized (removal of ovaries and/or uterus): consent to use non-hormonal contraception with an annual failure rate of < 1%, either singly or in combination, for the duration of the treatment period and at least 7 months after the last study treatment is required;
10. Women of childbearing age, with premenopausal or postmenopausal menopause of less than 12 months, who have not been surgically sterilized, and who have a negative serum pregnancy test.

排除标准：

1. IV期转移性乳腺癌或其他研究者判断不能通过新辅助治疗达到根治性手术切除的患者； 2. 双侧浸润性乳腺癌； 3. 既往接受过抗肿瘤治疗，如化疗、内分泌治疗或抗HER2的生物治疗或接受过乳腺手术的乳腺癌患者(除原发性乳腺癌的诊断活检外)； 4. 3年内出现过或当前同时患有其它恶性肿瘤。以下两种情况可以入组：经单一手术治疗的其他恶性肿瘤，达到连续5年的无疾病生存(DFS)；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[Ta(非浸润性肿瘤)，Tis(原位癌)和T1(肿瘤浸润基膜)]； 5. 研究治疗开始前28天内接受了重大外科治疗、切开活检或明显创伤性损伤(除原发性乳腺癌的诊断活检外)； 6. 长期未治愈的伤口或骨折； 7. 下列任何心脑血管疾病： (1) 随机前6个月内发生心肌梗死、不稳定性心绞痛、肺栓塞、主动脉夹层、深静脉血栓及任何动脉血栓栓塞事件； (2) 美国纽约心脏病协会(NYHA)心功能分级≥II级的心力衰竭； (3) 存在需要长期药物干预的严重心律失常；允许入组无症状、心室率稳定的心房颤动患者； (4) 随机前6个月内发生脑血管事件(CVA)； (5) 左室射血分数(LVEF)<50%； (6) 既往患有心肌炎或心肌病病史； (7) 经充分抗高血压药物治疗仍无法控制的高血压(定义为收缩压>150 mmHg，舒张压>100 mmHg)，或有发生高血压危象，高血压脑病的病史。 8. 具有精神类药物滥用史且无法戒除或有精神障碍者； 9. 活动性乙型病毒性肝炎受试者，非活动性或无症状的乙型肝炎病毒(HBV)携带者(乙型肝炎表面抗原[HBsAg]阳性、且HBV DNA＞1000 IU/mL)，及活动性丙型病毒性肝炎受试者；注：非活动性或无症状的携带者，经治疗且稳定的乙型肝炎受试者符合 HBV DNA ≤ 1000 IU/mL允许入组。已治愈的丙型病毒性肝炎受试者，HCVAb阳性且 HCV RNA阴性的受试者允许入组。 10. 人类免疫缺陷病毒(HIV)感染或已知患有获得性免疫缺陷综合征(艾滋病)； 11. 活动性梅毒感染； 12. 研究治疗开始前2周内接受过NMPA批准药物说明书中明确具有抗肿瘤适应症的中成药(包括复方斑蝥胶囊、康艾注射液、康莱特胶囊/注射剂、艾迪注射液、鸦胆子油注射剂/胶囊、消癌平片/注射剂、华蟾素胶囊等)治疗； 13. 影像学(CT或MRI)显示肿瘤已侵犯重要血管或经研究者判断在后续研究期间肿瘤极有可能侵袭重要血管而引起致命大出血者； 14. 研究治疗开始前2年内发生过需要全身性治疗(例如使用缓解疾病药物、皮质类固醇或免疫抑制剂)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皮质类固醇等)不视为全身性治疗； 15. 诊断为免疫缺陷或正在接受全身性糖皮质激素治疗或任何其他形式的免疫抑制疗法。(剂量>10mg/天泼尼松或其他等疗效激素)，并首次给药2周内仍在继续使用的； 16. 其他会干扰计划治疗的并发病，包括重度肺功能障碍/疾病，活动性或未能控制的严重感染(≥CTCAE 5.0 2级感染)； 17. 已知异体器官移植史和异体造血干细胞移植史； 18. 已知间质性肺病或非感染性肺炎的病史； 19. 对任何研究药物或药物中的任何成分或辅料过敏； 20. 分组前4周内参加过其他抗肿瘤药物临床试验； 21. 根据研究者的判断，有严重危害受试者安全或影响完成研究的伴随疾病者，或认为存在其他原因不适合入组的受试者； 22. 患有活动性或有病史记录的炎症性肠病(如克罗恩病、溃疡性结肠炎)、活动性憩室炎。存在胃肠道梗阻的临床表现，或需要常规肠外补液、肠外营养或留置胃管。

Exclusion criteria：

1. Stage IV metastatic breast cancer or other patients who, in the judgment of the investigator, cannot achieve radical surgical resection with neoadjuvant therapy; 2. Bilateral invasive breast cancer; 3. Breast cancer patients with prior anti-tumor therapy, such as chemotherapy, endocrine therapy, or anti-HER2 biologic therapy, or who have undergone breast surgery (except for diagnostic biopsies for primary breast cancer); 4. Presence of or current concurrent other malignancies within 3 years. Two of the following are eligible for enrollment: other malignancies treated with a single surgical procedure to achieve 5 consecutive years of disease-free survival (DFS); cured carcinoma in situ of the uterine cervix, non-melanoma skin cancers, and superficial bladder tumors [Ta (non-invasive tumors), Tis (carcinoma in situ), and T1 (tumors infiltrating the basement membrane)]; 5. Major surgical treatment, incisional biopsy, or significant traumatic injury (other than diagnostic biopsy for primary breast cancer) within 28 days prior to the start of study treatment; 6. Long-standing unhealed wounds or fractures; 7. Any of the following cardiovascular diseases (1) Myocardial infarction, unstable angina, pulmonary embolism, aortic coarctation, deep vein thrombosis, and any arterial thromboembolic event in the 6 months prior to randomization; (2) Heart failure with a New York Heart Association (NYHA) cardiac function class >= II; (3) Presence of severe arrhythmias requiring long-term pharmacological intervention; enrollment of patients with asymptomatic, ventricular rate-stabilized atrial fibrillation is permitted; (4) Cerebrovascular event (CVA) within 6 months prior to randomization; (5) Left ventricular ejection fraction (LVEF) < 50%; (6) Previous history of myocarditis or cardiomyopathy; (7) Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and diastolic blood pressure >100 mmHg) despite adequate antihypertensive medication, or a history of hypertensive crisis, hypertensive encephalopathy. 8. Persons with a history of psychotropic substance abuse that cannot be withdrawn or who are mentally challenged; 9. Subjects with active viral hepatitis B, inactive or asymptomatic hepatitis B virus (HBV) carriers (hepatitis B surface antigen [HBsAg]-positive with HBV DNA >1000 IU/mL), and active viral hepatitis C subjects; Note: Inactive or asymptomatic carriers, treated and stable subjects with hepatitis B meeting HBV DNA <=1000 IU/mL are allowed to enroll. Cured subjects with viral hepatitis C, HCVAb-positive and HCV RNA-negative subjects are allowed to enroll. 10. Human Immunodeficiency Virus (HIV) infection or known to have Acquired Immune Deficiency Syndrome (AIDS); 11. Active syphilis infection; 12. Received treatment with proprietary Chinese medicines with anti-tumor indications as specified in the NMPA-approved drug inserts (including Compound Zebu Capsules, Kang'ai Injection, Kang'ai Capsules/Injection, Ai Di Injection, Crow's berry oil injection/capsules, Cancer elimination tablets/injection, Huazhuanin Capsules, etc) within 2 weeks prior to the commencement of study treatment; 13. Those whose imaging (CT or MRI) shows that the tumor has invaded important blood vessels or who, in the judgment of the investigator, have a high likelihood of fatal hemorrhage due to tumor invasion of important blood vessels during the follow-up study; 14.Active autoimmune disease requiring systemic therapy (e.g., use of palliative medications, corticosteroids, or immunosuppressive agents) within 2 years prior to the start of study treatment. Alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) are not considered systemic therapy; 15. Diagnosis of immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy. (dose >10 mg/day prednisone or other equipotent hormone) that is continuing within 2 weeks of the first dose; 16. Other comorbidities that would interfere with planned therapy, including severe pulmonary dysfunction/disease, active or uncontrolled serious infections (>= CTCAE 5.0 grade 2 infections); 17. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 18. History of known interstitial lung disease or non-infectious pneumonia; 19. Hypersensitivity to any of the investigational drugs or any of the ingredients or excipients in the drugs; 20. Participation in a clinical trial of another antitumor drug within 4 weeks prior to subgrouping; 21. Subjects who, in the judgment of the investigator, have a concomitant medical condition that seriously jeopardizes the safety of the subject or interferes with the completion of the study, or who are deemed to have other reasons for being unsuitable for enrollment; 22. Have active or documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), active diverticulitis. Presence of clinical signs of gastrointestinal obstruction or need for routine parenteral rehydration, parenteral nutrition, or indwelling gastrostomy tube.

研究实施时间：

Study execute time：

从 From 2022-12-01 00:00:00至 To 2027-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2023-01-01 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	35
Group：	Test group	Sample size：	35
干预措施：	卡度尼利单抗联合化疗	干预措施代码：
Intervention：	Cadonilimab combined with chemotherapy	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	湖南	市(区县)：	常德
Country：	China	Province：	Hu'nan	City：	Changde
单位(医院)：	常德市第一人民医院	单位级别：	三级甲等
Institution hospital：	Changde First People's Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	湖南	市(区县)：	岳阳
Country：	China	Province：	Hu'nan	City：	Yueyang
单位(医院)：	湖南省第三人民医院	单位级别：	三级
Institution hospital：	The third people's Hospital of Hunan Province	Level of the institution：	Tertiary

国家：	中国	省(直辖市)：	湖南	市(区县)：	永州
Country：	China	Province：	Hu'nan	City：	Yongzhou
单位(医院)：	永州市中心医院	单位级别：	三级甲等
Institution hospital：	The Central Hospital of Yongzhou	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	总病理完全缓解率	指标类型：	主要指标
Outcome：	Total pathological complete response rate	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	乳腺病理完全缓解率	指标类型：	次要指标
Outcome：	breast pathological complete 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：	保乳率	指标类型：	次要指标
Outcome：	breast-conserving surgery 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：	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：

指标中文名：	无病生存期	指标类型：	次要指标
Outcome：	Disease-free survival	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	总生存期	指标类型：	次要指标
Outcome：	Overall Survival	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	安全性	指标类型：	次要指标
Outcome：	safety	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：
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：

正在进行

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）：

非随机

Randomization Procedure (please state who generates the random number sequence and by what method)：

N/A

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）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是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）：	研究公开发表后可通过与研究者（20689452@qq.com）联系索取
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	After the study is published, it can be obtained by contacting the researcher (20689452@qq.com)..
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
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2022-12-23 14:28:49