ChiCTR2600127200 版本V1.0 版本创建时间2026/06/26 14:30:17 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：

 ChiCTR2600127200 

最近更新日期：

Date of Last Refreshed on：

 2026-06-26 14:29:40 

注册时间：

Date of Registration：

 2026-06-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

NeoTRECAMCT-01：SHR-A1811+卡瑞利珠单抗在围手术期联合或序贯化疗治疗 ER(-)/ER(1-10%)、HER2 低表达早期或局部晚期乳腺癌的前瞻性、非随机对照临床研究

Public title：

NeoTRECAMCT-01：A prospective, non-randomized controlled clinical study of SHR-A1811 plus camrelizumab in perioperative combination or sequential chemotherapy for ER(-)/ER(1-10%), HER2-low expressing early or locally advanced breast cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

NeoTRECAMCT-01：SHR-A1811+卡瑞利珠单抗在围手术期联合或序贯化疗治疗 ER(-)/ER(1-10%)、HER2 低表达早期或局部晚期乳腺癌的前瞻性、非随机对照临床研究

Scientific title：

NeoTRECAMCT-01：A prospective, non-randomized controlled clinical study of SHR-A1811 plus camrelizumab in perioperative combination or sequential chemotherapy for ER(-)/ER(1-10%), HER2-low expressing early or locally advanced 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：

张伟 

研究负责人：

张伟 

Applicant：

Zhang Wei 

Study leader：

Zhang Wei 

申请注册联系人电话：

Applicant telephone：

 +86 15929323845

研究负责人电话：

Study leader's
telephone：

+86 29 85324926

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：

 59004940@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 59004940@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：

陕西省西安市雁塔区雁塔西路277号

研究负责人通讯地址：

陕西省西安市雁塔西路277号

Applicant address：

No. 277, Yanta West Road, Yanta District, Xi'an, Shaanxi ,China

Study leader's address：

No. 277, Yanta West Road, Yanta District, Xi'an, Shaanxi ,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：

西安交通大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Xi'an Jiaotong University

研究负责人所在单位：

西安交通大学第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Xi'an Jiaotong 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：

 XJTU1AF2026LSYY-0355

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：

西安交通大学第一附属医院医学伦理委员会

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Xian Jiaotong University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-05-26 00:00:00

伦理委员会联系人：

易秋月

Contact Name of the ethic committee：

Yi QiuYue

伦理委员会联系地址：

陕西省西安市雁塔西路277号

Contact Address of the ethic committee：

No. 277, Yanta West Road, Yanta District, Xi'an, Shaanxi ,China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 29 85323473

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 yqy0118@163.com

研究实施负责（组长）单位：

西安交通大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Xi'an Jiaotong University

研究实施负责（组长）单位地址：

陕西省西安市雁塔西路277号

Primary sponsor's address：

No. 277, Yanta West Road, Yanta District, Xi'an, Shaanxi ,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)：

陕西省

市(区县)：

Country：

China

Province：

Shaanxi

City：

单位(医院)：

西安交通大学第一附属医院

具体地址：

陕西省西安市雁塔西路277号

Institution
hospital：

The First Affiliated Hospital of Xi'an Jiaotong University

Address：

No. 277, Yanta West Road, Yanta District, Xi'an, Shaanxi ,China

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-selected project (self-funded)

研究疾病：

雌激素受体低表达（ER <10%）、HER2低表达［定义为免疫组化（IHC）1+，或IHC 2+且原位杂交（ISH）检测无扩增］的早期或局部晚期乳腺癌  

Target disease：

Early or locally advanced breast cancer with low estrogen receptor expression (ER <10%) and low HER2 expression, defined as immunohistochemistry (IHC) 1+, or IHC 2+ with no amplification detected by in situ hybridization (ISH).

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：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

为探索更高疗效的强化治疗方案，本研究设计了一项前瞻性、非随机对照研究。试验组拟采用瑞康曲妥珠单抗（SHR-A1811）联合卡瑞利珠单抗序贯多西他赛、卡铂联合卡瑞利珠单抗的创新方案。基于前述靶免联合方案的卓越数据，预设试验组 pCR 率为 75%。对照组将来源于同期在本中心接受传统新辅助化疗的患者队列（预估 pCR 率 38%）。为增强组间可比性、控制混杂偏倚，研究将采用倾向评分匹配等方法，依据关键的临床病理特征（如肿瘤分期、分子分型等）从该同期队列中为试验组患者匹配对照组患者。  

Objectives of Study：

In order to explore a more effective intensive treatment, this study designed a prospective, non randomized controlled study. The experimental group plans to adopt the innovative scheme of Ruikang trastuzumab (shr-a1811) combined with carrelizumab followed by docetaxel and carboplatin combined with carrelizumab. Based on the excellent data of the above target immune combination scheme, the pre-set PCR rate of the experimental group was 75%. The control group will be from the cohort of patients who received traditional neoadjuvant chemotherapy in our center at the same time (the estimated PCR rate is 38%). In order to enhance comparability between groups and control confounding bias, the study will use propensity score matching and other methods to match the patients in the experimental group with the patients in the control group from the same cohort according to the key clinicopathological characteristics (such as tumor staging, molecular typing, etc.).

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. 年龄大于等于 18 岁且小于等于 70 岁；
2. 经组织病理学证实的浸润性乳腺癌；
3. 经组织病理学证实的、雌激素受体低表达（ER <10%）、HER2低表达［定义为免疫组化（IHC）1+，或IHC 2+且原位杂交（ISH）检测无扩增］的乳腺癌患者。
4. 肿瘤分期符合第八版AJCC乳腺癌分期标准的，临床分期为 T1cN1-2M0，或 T2-3N0-2M0 的初治乳腺癌患者；
5. 根据RECIST V1.1，至少有一个可测量的靶病灶；
6. ECOG功能状态评分 0~1分；
7. 重要器官的功能水平必须符合要求（首次用药前14天内未使用任何血液成分、细胞生长因子进行纠正治疗）;
8. 对于绝经前有生育可能的妇女必须在开始治疗之前的 7 天内做妊娠试验，血清妊娠必须为阴性，必须为非哺乳期；所有入组患者均应在整个治疗周期及治疗结束后 6 个月采取充分的屏障避孕措施；
9. 自愿加入本研究，签署知情同意，有良好的依从性并愿意配合访视和研究相关程序。

Inclusion criteria

1.Age >=18 years and <=70 years; 2.Histopathologically confirmed invasive breast cancer; 3.Histopathologically confirmed breast cancer with low estrogen receptor expression (ER <10%) and low HER2 expression [defined as immunohistochemistry (IHC) 1+, or IHC 2+ with no amplification detected by in situ hybridization (ISH)]; 4.Treatment-na?ve breast cancer patients with tumor staging according to the 8th edition of AJCC breast cancer staging criteria: clinical stage T1cN1-2M0, or T2-3N0-2M0; 5.At least one measurable target lesion according to RECIST v1.1; 6.ECOG performance status score of 0–1; 7.Adequate function of vital organs (no correction treatment with any blood components or cell growth factors within 14 days prior to the first dose); 8.For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days prior to the start of treatment and must be negative; patients must be non-lactating; all enrolled patients must adopt adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion; 9.Voluntarily agree to participate in this study, sign informed consent, have good compliance, and be willing to comply with follow-up visits and study-related procedures.

排除标准：

1. 未经病理组织学确诊的乳腺癌；
2. 双侧乳腺癌、炎性乳腺癌或隐匿性乳腺癌；
3. 既往5年内患有其它恶性肿瘤，已治愈的皮肤基底细胞癌和宫颈原位癌除外；
4. 首次用药前2周内使用过免疫抑制剂或全身激素治疗以达到免疫抑制目的者（剂量>10 mg/d泼尼松或同等药物生理学剂量的其他皮质类固醇激素），不包括鼻喷或吸入性皮质类固醇激素；
5. 首次用药前4周内接种活疫苗及减毒疫苗；
6. 首次用药前4周内接受过重大与乳腺癌无关的手术操作，或尚未从此类手术操作中完全恢复；
7. 存在任何活动性自身免疫病或有自身免疫疾病史且可能复发[包括但不局限于：自身免疫性肝炎、葡萄膜炎、肠炎、垂体炎、血管炎、肾炎、甲状腺功能亢进、 甲状腺功能减退（仅通过激素替代治疗可以控制的受试者可纳入）]；受试者患有无需系统治疗的皮肤病如白癜风、银屑病、脱发，接受胰岛素治疗的经控制的I型糖尿病或在童年期哮喘已完全缓解，成人后无需任何干预的可纳入；需要支气管扩张剂进行医学干预的哮喘患者则不能纳入；
8. 存在免疫缺陷病史，包括HIV检测阳性，其他获得性、先天性免疫缺陷疾病， 或有器官移植史；
9. 存在无法控制或重要的心脑血管疾病，包括（但不限于）：首次给药前6个月内发生以下任何情况：如充血性心力衰竭（NYHA III或IV级）、心肌梗塞或脑梗塞（腔隙性脑梗塞除外），肺栓塞，不稳定型心绞痛，或者在筛选时存在需要治疗的心律失常；原发性心肌病（如扩张型心肌病、肥厚型心肌病、致心律失常性右室心肌病、限制型心肌病、未定型心肌病）；具有临床意义的QTc期延长病史， II度II型房室传导阻滞或III度房室传导阻滞或QTc间期（F法）＞470 msec（女性）； 房颤（EHRA分级≥2b级）；难以控制的高血压，经研究者判断不适合参加研究；
10. 已知或可疑有间质性肺炎的受试者；首次给药前三个月内存在其他可能干扰药物相关肺毒性检测或处理的、严重影响呼吸功能的中重度肺部疾病，包括但不限于特发性肺组织纤维化、机化性肺炎/闭塞性细支气管炎、肺栓塞、严重哮喘、 严重慢性阻塞性肺疾病（COPD）、阻塞性/限制性肺病等；以及任何肺部受累的自身免疫性、结缔组织或炎症性疾病，例如类风湿性关节炎、干燥综合症、结节病等，或既往接受过全肺切除手术等；
11. 存在活动性乙型肝炎（HBsAg阳性且HBV DNA≥500 IU/mL）、丙型肝炎（丙肝抗体阳性且HCV RNA高于正常值范围上限）、肝硬化；或需要抗生素、抗病毒药物或抗真菌药物控制的严重感染者；
12. 已知存在的遗传性或获得性出血及血栓倾向（如血友病、凝血功能障碍等）；
13. 已知对研究药物及其辅料成分过敏或禁忌的患者；
14. 妊娠期、哺乳期女性患者，有生育能力且基线妊娠试验检测阳性的女性患者或在整个试验期间不愿意采取有效避孕措施的育龄女性患者;
15. 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（包括但不限于药物无法控制的严重高血压、严重的糖尿病、活动性感染等）；
16. 既往有明确的神经或精神障碍史，包括癫痫或痴呆，或研究者认为患者不适合参加本研究的其他任何情况。

Exclusion criteria：

1.Breast cancer not confirmed by histopathology; 2.Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer; 3.Diagnosis of another malignancy within the past 5 years, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ; 4.Use of immunosuppressive agents or systemic hormone therapy for immunosuppressive purposes within 2 weeks prior to the first dose (dose >10 mg/day of prednisone or equivalent physiological doses of other corticosteroids), excluding nasal or inhaled corticosteroids; 5.Receipt of live or attenuated vaccines within 4 weeks prior to the first dose; 6.Major surgery unrelated to breast cancer within 4 weeks prior to the first dose, or not fully recovered from such surgery; 7.Presence of any active autoimmune disease or history of autoimmune disease with potential for relapse [including but not limited to: autoimmune hepatitis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (subjects controlled with hormone replacement therapy only may be included)]; subjects with skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia), controlled type I diabetes mellitus managed with insulin therapy, or childhood asthma that has completely resolved and requires no intervention in adulthood may be included; asthmatic patients requiring medical intervention with bronchodilators are excluded; 8.History of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 9.Presence of uncontrolled or significant cardiovascular or cerebrovascular disease, including (but not limited to): any of the following occurring within 6 months prior to the first dose – congestive heart failure (NYHA class III or IV), myocardial infarction or cerebral infarction (excluding lacunar infarction), pulmonary embolism, unstable angina, or arrhythmia requiring treatment at screening; primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy); history of clinically significant QTc prolongation, second-degree type II atrioventricular block, third-degree atrioventricular block, or QTcF >470 msec (female); atrial fibrillation (EHRA grade ≥2b); uncontrolled hypertension that the investigator deems makes the subject unsuitable for study participation; 10.Subjects with known or suspected interstitial lung disease; presence within 3 months prior to the first dose of other moderate-to-severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity or seriously affect respiratory function, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/obliterative bronchiolitis, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), obstructive/restrictive lung disease, etc.; and any autoimmune, connective tissue, or inflammatory disease involving the lungs, such as rheumatoid arthritis, Sj?gren's syndrome, sarcoidosis, etc., or previous total pneumonectomy; 11.Presence of active hepatitis B (HBsAg positive and HBV DNA >=500 IU/mL), hepatitis C (HCV antibody positive and HCV RNA above the upper limit of normal range), or cirrhosis; or severe infection requiring control with antibiotics, antivirals, or antifungal agents; 12.Known inherited or acquired bleeding or thrombotic tendencies (e.g., hemophilia, coagulation dysfunction, etc.). 13.Known allergy or contraindication to the study drug or any of its excipients; 14.Pregnant or lactating women, women of childbearing potential with a positive baseline pregnancy test, or women of childbearing potential who are unwilling to use effective contraceptive measures throughout the study period; 15.According to the investigator's judgment, presence of any concomitant disease that may seriously endanger patient safety or affect the patient's ability to complete the study (including but not limited to severe hypertension uncontrollable by medication, severe diabetes, active infection, etc.); 16.A definite history of neurological or psychiatric disorders, including epilepsy or dementia, or any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study.

研究实施时间：

Study execute time：

从 From 2026-06-30 00:00:00至 To 2028-12-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-30 00:00:00 至 To 2027-06-30 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 37

Group：

Control group

Sample size：

干预措施：

传统新辅助化疗

干预措施代码：

Intervention：

Conventional neoadjuvant chemotherapy

Intervention code：

组别：

试验组

样本量：

 37

Group：

Treatment group

Sample size：

干预措施：

瑞康曲妥珠单抗（SHR-A1811）联合卡瑞利珠单抗序贯多西他赛、卡铂联合卡瑞利珠单抗

干预措施代码：

Intervention：

Trasturzrmb Rezetean(SHR-A1811) combined with camrelizumab, sequentially followed by docetaxel and carboplatin combined with camrelizumab

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

City：

单位(医院)：

 西安交通大学第一附属医院 

单位级别：

 三级甲等 

Institution
hospital：

The First Affiliated Hospital of Xi'an Jiaotong University

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 remission rate

Type：

Primary indicator

测量时间点：

新辅助治疗结束后手术时

测量方法：

术后病理评估

Measure time point of outcome：

At surgery post-neoadjuvant therapy

Measure method：

Postoperative pathology assessment

指标中文名：

安全性指标

指标类型：

次要指标

Outcome：

Safety outcome

Type：

Secondary indicator

测量时间点：

从签署知情同意书至治疗结束后30天

测量方法：

不良事件（AE）和严重不良事件（SAE）按照NCI CTCAE v5.0标准进行分级和记录；同时监测生命体征、体格检查、实验室检查（血常规、血生化、尿常规、甲状腺功能、心肌酶等）、心电图（QTcF）、免疫相关不良事件等。

Measure time point of outcome：

From informed consent through 30 days after last dose

Measure method：

Adverse events (AEs) and serious adverse events (SAEs) graded according to NCI CTCAE v5.0; monitoring of vital signs, physical examination, laboratory tests (complete blood count, blood chemistry, urinalysis, thyroid function, cardiac enzymes, etc.), electrocardiogram (QTcF), immune-related adverse events, etc.

指标中文名：

Ki-67指数变化

指标类型：

次要指标

Outcome：

Change in Ki-67 index

Type：

Secondary indicator

测量时间点：

基线（治疗前穿刺活检）和新辅助治疗后手术时

测量方法：

采用免疫组化（IHC）法检测肿瘤组织Ki-67增殖指数，计算阳性细胞百分比。变化值 = 治疗后Ki-67值 - 治疗前Ki-67值。

Measure time point of outcome：

Baseline (pre-treatment core biopsy) and at surgery after neoadjuvant therapy

Measure method：

Ki-67 index assessed by immunohistochemistry (IHC); percentage of Ki-67-positive tumor cells. Change = post-treatment value minus baseline value.

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：

新辅助治疗结束后

测量方法：

依据RECIST 1.1标准进行影像学评估（如CT、MRI等），计算靶病灶达到完全缓解（CR）或部分缓解（PR）的患者比例。

Measure time point of outcome：

After neoadjuvant therapy

Measure method：

Radiological assessment per RECIST v1.1; ORR defined as proportion of patients achieving complete response (CR) or partial response (PR).

指标中文名：

保乳率

指标类型：

次要指标

Outcome：

Breast-conserving rate (BCR)

Type：

Secondary indicator

测量时间点：

手术后

测量方法：

保乳手术患者数 / 所有接受手术的患者数 × 100%。保乳手术定义为切除全部肿瘤且切缘阴性，保留大部分乳房外形的手术。

Measure time point of outcome：

After surgery

Measure method：

Breast-conserving rate = (Number of patients undergoing breast-conserving surgery) / (Total number of patients who received surgery) × 100%. Breast-conserving surgery is defined as complete tumor resection with negative margins while preserving the majority of the breast contour.

指标中文名：

无事件生存期

指标类型：

次要指标

Outcome：

Event-Free Survival (EFS)

Type：

Secondary indicator

测量时间点：

随访期间从首次用药至首次发生以下任何事件：疾病进展（局部或远处复发）、第二原发恶性肿瘤（非乳腺癌）、任何原因导致的死亡。

测量方法：

记录从首次给药日期至首次发生以下任何事件的时间：疾病进展（局部或远处复发）、第二原发恶性肿瘤（非乳腺癌）、任何原因导致的死亡。未发生事件的患者在末次随访时进行删失。评估依据影像学（RECIST 1.1）、临床检查及病理确认。

Measure time point of outcome：

During follow-up (from first dose to the first occurrence of any of the following events)

Measure method：

Time from first dose to first occurrence of any of the following events: disease progression (local or distant recurrence), second primary malignancy (non-breast cancer), or death from any cause. Patients without an event are censored at the last follow-up. Assessment based on imaging (RECIST 1.1), clinical examination, and pathological confirmation.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液样本

组织：

Sample Name：

Blood sample

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：

乳腺癌肿瘤组织样本

组织：

Sample Name：

Breast cancer tumor tissue sample

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 70 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:

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）：

不适用

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

Not applicable

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：

本研究采用电子病例报告表（eCRF）进行数据采集，使用电子数据采集系统（EDC，如Viedoc、Rave、或本中心自建系统）进行数据录入、核查和管理。所有数据变更保留审计追踪。研究数据由主要研究者指定的数据管理员负责，定期备份。

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

Electronic Case Report Form (eCRF) and Electronic Data Capture (EDC) system (e.g., Viedoc/Rave). Data entry, verification, and management with audit trail. Data are managed by a designated data manager under the supervision of the principal investigator.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-06-26 14:29:40