ChiCTR2500098742 版本V1.1 版本创建时间2025/12/31 14:06:05 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：

ChiCTR2500098742 

最近更新日期：

Date of Last Refreshed on：

2025-03-13 09:17:16 

注册时间：

Date of Registration：

2025-03-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

口服泊沙康唑联合化疗、PD-1抑制剂在早期或局部晚期三阴性乳腺癌新辅助治疗的疗效和安全性的多中心、随机对照II期临床研究

Public title：

A multicenter, randomized controlled phase II clinical study of oral posaconazole combined with chemotherapy and PD-1 inhibitors as neoadjuvant treatment for early or locally advanced triple-negative breast cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

口服泊沙康唑联合化疗、PD-1抑制剂在早期或局部晚期三阴性乳腺癌新辅助治疗的疗效和安全性的多中心、随机对照II期临床研究

Scientific title：

A multicenter, randomized controlled phase II clinical study of oral posaconazole combined with chemotherapy and PD-1 inhibitors as neoadjuvant treatment for early or locally advanced 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：

石志强 

研究负责人：

邱鹏飞 

Applicant：

Shi Zhiqiang 

Study leader：

Qiu Pengfei 

申请注册联系人电话：

Applicant telephone：

+86 183 9686 6223

研究负责人电话：

Study leader's telephone：

+86 186 1520 5204

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：

shizhiqiang1024@163.com

研究负责人电子邮件：

Study leader's E-mail：

qiu.pf@outlook.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：

山东省济南市槐荫区济兖路440号

研究负责人通讯地址：

山东省济南市槐荫区济兖路440号

Applicant address：

No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province

Study leader's address：

No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province

申请注册联系人邮政编码：

Applicant postcode：

250117

研究负责人邮政编码：

Study leader's postcode：

250117

申请人所在单位：

山东第一医科大学附属肿瘤医院(山东省肿瘤医院 山东省肿瘤防治研究院)

Applicant's institution：

Cancer Hospital of Shandong First Medical University (Shandong Cancer institute, Shandong Cancer Hospital)

研究负责人所在单位：

山东第一医科大学附属肿瘤医院(山东省肿瘤医院 山东省肿瘤防治研究院

Affiliation of the Leader：

Cancer Hospital of Shandong First Medical University (Shandong Cancer institute, Shandong 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：

SDZLEC2025-029-02

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：

山东第一医科大学附属肿瘤医院伦理委员会

Name of the ethic committee：

Ethics Committee of Cancer Hospital of Shandong First Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-02-28 00:00:00

伦理委员会联系人：

李朝伟

Contact Name of the ethic committee：

Li Chaowei

伦理委员会联系地址：

山东省济南市槐荫区济兖路440号

Contact Address of the ethic committee：

No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 531 6762 6929

伦理委员会联系人邮箱：

Contact email of the ethic committee：

sdzlllh803@126.com

研究实施负责（组长）单位：

山东第一医科大学附属肿瘤医院(山东省肿瘤医院 山东省肿瘤防治研究院)

Primary sponsor：

Cancer Hospital of Shandong First Medical University (Shandong Cancer institute, Shandong Cancer Hospital)

研究实施负责（组长）单位地址：

山东省济南市槐荫区济兖路440号

Primary sponsor's address：

No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

山东

市(区县)：

济南

Country：

China

Province：

Shandong

City：

Jinan

单位(医院)：

山东第一医科大学附属肿瘤医院(山东省肿瘤医院 山东省肿瘤防治研究院)

具体地址：

山东省济南市槐荫区济兖路440号

Institution
hospital：

Cancer Hospital of Shandong First Medical University (Shandong Cancer institute, Shandong Cancer Hospital)

Address：

No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province

经费或物资来源：

中国医药卫生事业发展基金会医药科研课题项目，吴阶平医学基金会临床科研专项资助基金项目，英国皇家学会国际合作交流项目

Source(s) of funding：

Medical research project of China Medical and Health Development Foundation, Clinical Research Special funding project of Wu Jieping Medical Foundation, International cooperation and exchange project of the Royal Society of Britain

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1.口服泊沙康唑的有效性和安全性 2.口服泊沙康唑与PD-1抑制剂联合在抗肿瘤免疫治疗中的协同机制  

Objectives of Study：

1.The efficacy and safety of oral posaconazole. 2. The synergistic mechanism of oral posaconazole combined with PD-1 inhibitors in antitumor immune therapy.

药物成份或治疗方案详述：

试验组： 泊沙康唑肠溶片：第1天，300 mg bid；第2天开始维持剂量，300 mg qd，口服给药，21天为一个治疗周期，共8个周期。 白蛋白紫杉醇 260mg/m2+卡铂 AUC 6mg/mL/min 持续4周期序贯表柔比星 100mg/m2或多柔比星 60mg/m2+环磷酰胺 600mg/m2 持续4周期，每个周期第1天静脉给药一次，21天为一个治疗周期，共8个周期。根据患者实际情况，由研究者判断选择不同的化学治疗药物，根据说明书用药，可剂量调整。 PD-1抑制剂：帕博利珠单抗，200mg， 每个周期第1天静脉给药一次，21天为一个治疗周期，共8个周期。根据患者实际情况，由研究者判断选择不同的免疫治疗药物，根据说明书用药，可剂量调整。 对照组： 白蛋白紫杉醇 270mg/m2+卡铂 AUC 6mg/mL/min 持续4周期序贯表柔比星 100mg/m2或多柔比星 60mg/m2+环磷酰胺 600mg/m2 持续4周期，每个周期第1天静脉给药一次，21天为一个治疗周期，共8个周期。根据患者实际情况，由研究者判断选择不同的化学治疗药物，根据说明书用药，可剂量调整。 PD-1抑制剂：帕博利珠单抗等，200mg， 每个周期第1天静脉给药一次，21天为一个治疗周期，共8个周期。根据患者实际情况，由研究者判断选择不同的免疫治疗药物，根据说明书用药，可剂量调整。 

Description for medicine or protocol of treatment in detail：

Experimental Group: Posaconazole Delayed-Release Tablets: On the 1st day, 300 mg twice daily (bid); starting from the 2nd day, maintenance dose of 300 mg once daily (qd), oral administration, with a 21-day treatment cycle, for a total of 8 cycles. Albumin-bound paclitaxel 260mg/m2 + carboplatin AUC 6mg/mL/min for 4 cycles, followed by epirubicin 100mg/m2 or doxorubicin 60mg/m2 + cyclophosphamide 600mg/m2 for 4 cycles, administered intravenously once on the 1st day of each cycle, with a 21-day treatment cycle, for a total of 8 cycles. Based on the actual condition of the patient, the researcher may choose different chemotherapy drugs, according to the instructions for use, with possible dose adjustments. PD-1 Inhibitor: Pembrolizumab, etc., 200mg, administered intravenously once on the 1st day of each cycle, with a 21-day treatment cycle, for a total of 8 cycles. Based on the actual condition of the patient, the researcher may choose different immunotherapy drugs, according to the instructions for use, with possible dose adjustments. Control Group: Albumin-bound paclitaxel 270mg/m2 + carboplatin AUC 6mg/mL/min for 4 cycles, followed by epirubicin 100mg/m2 or doxorubicin 60mg/m2 + cyclophosphamide 600mg/m2 for 4 cycles, administered intravenously once on the 1st day of each cycle, with a 21-day treatment cycle, for a total of 8 cycles. Based on the actual condition of the patient, the researcher may choose different chemotherapy drugs, according to the instructions for use, with possible dose adjustments. PD-1 Inhibitor: Pembrolizumab, 200mg, administered intravenously once on the 1st day of each cycle, with a 21-day treatment cycle, for a total of 8 cycles. Based on the actual condition of the patient, the researcher may choose different immunotherapy drugs, according to the instructions for use, with possible dose adjustments. 

纳入标准：

1.在实施任何试验相关流程之前，签署书面知情同意 2.女性，年龄18岁或以上，70岁或以下 3.ECOG PS 0-1 4.病理证实的原发性单灶浸润性乳腺癌： (1) 肿瘤分期：cT1cN1-3M0 or cT2-4N0-3M0，TNM分期参考《第八版AJCC癌症分期手册》 (2) HER2阴性：定义为IHC0或IHC1+或IHC2+且FISH- (3) 雌激素受体（ER）和孕激素受体（PR）阴性：＜1% 5.有生育能力的女性患者必须同意在研究期间和末次研究用药6个月内使用有效的避孕方法。育龄期女性妊娠试验（尿液或血清）必须为阴性 6.主要器官功能正常（在入组前14天），即符合下列标准： (1) 血常规检查标准需符合（入组前14天内未输血及未接受粒细胞集落刺激因子治疗）： a) 血红蛋白（HB）≥90g/L b) 中性粒细胞（ANC）≥1.0×109/L c) 血小板（PLT）≥75×109/L (2) 无功能器质性疾病，需符合以下标准： a) 血清总胆红素≤1.5 X ULN或直接胆红素≤ULN（总胆红素水平>1.5 ULN） b) 谷丙转氨酶（ALT）和谷草转氨酶（AST）≤2.5×ULN； c) 碱性磷酸酶ALP ，如果大于2.5 X ULN，则肝脏分数应≤2.5 X ULN d) 血清肌酐水平Cr≤1.5xULN或计算出的肌酐清除率（MDRD公式计算）≥40ml/min且Cr＞1.5xULN e) 尿蛋白<2+，如果试纸≥2+，则24小时尿蛋白必须<2g，或尿蛋白-肌酐比值（UPC）必须<2 f) 国际标准化比值（INR）、活化部分凝血活酶时间（aPTT）：≤1.5×ULN

Inclusion criteria

1. Sign written informed consent before implementing any procedures related to the trial 2. Female, age 18 or older, 70 or younger 3.ECOG PS 0-1 4. Pathologically confirmed primary single-focal invasive breast cancer: (1) Tumor staging: cT1cN1-3M0 or cT2-4N0-3M0, TNM staging refer to the Eighth Edition AJCC Cancer Staging Manual (2) HER2 negative: defined as IHC0 or IHC1+ or IHC2+ and FISH- (3) Estrogen receptor (ER) and progesterone receptor (PR) negative: < 1% 5. Fertile female patients must consent to the use of an effective contraceptive method during the study period and within 6 months of the last study medication. Pregnancy tests (urine or serum) for women of childbearing age must be negative 6. Major organ function is normal (14 days before enrollment), which meets the following criteria: (1) Blood routine examination criteria should be met (no blood transfusion and no treatment with granulocyte colony stimulating factor within 14 days prior to enrollment) : a) Hemoglobin (HB) >=90g/L b) Neutrophils (ANC) >=1.0×109/L c) Platelet (PLT) >=75×109/L (2) No functional organic disease, must meet the following criteria: a) Serum total bilirubin <=1.5 X ULN or direct bilirubin <=ULN (total bilirubin level >1.5 ULN) b) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5×ULN; c) Alkaline phosphatase ALP, if greater than 2.5 X ULN, the liver fraction should be <=2.5 X ULN d) Serum creatinine level (Cr) <=1.5xULN or calculated creatinine clearance (calculated by MDRD formula) >=40ml/min and Cr > 1.5xULN e) Urinary protein <2+, if the test strip is >=2+, the 24-hour urinary protein must be <2g, or the urinary protein-creatinine ratio (UPC) must be <2 f) International Standardized ratio (INR), activated partial thromboplastin time (aPTT) : <=1.5×ULN

排除标准：

1. IV期转移性乳腺癌 2. 炎性乳腺癌 3. 双侧原发乳腺癌（包括浸润性癌和原位癌） 4. 既往因任何恶性肿瘤接受过抗肿瘤治疗或放射治疗，不包括已治 愈的宫颈原位癌、皮肤基底细胞癌和鳞状细胞癌 5. 接受任何性激素治疗（例如避孕药、卵巢激素替代治疗等），或任 何激素药物（如雷洛昔芬、他莫昔芬或其他选择性雌激素受体调 节剂）治疗骨质疏松症或乳腺癌预防 6. 随机化前4周内接受过与乳腺癌无关的重大手术操作或患者尚未 完全恢复 7. 有症状的周围神经病变 CTCAE 5.0 等级评价≥2 级 8. 严重的心脑血管疾病，包括但不限于： (1)充血性心力衰竭或收缩功能障碍（LVEF<50%）病史 (2)需要使用抗心绞痛药物的心绞痛 (3)高风险未控制的心律失常或严重传导异常，如需要临床干预的室性心律失常、II-III 度房室传导阻滞等；静息状态下，3 次12导联心电图检查得出的平均 QTcF>470ms (4)有临床意义的心脏瓣膜病伴心脏功能损害 (5)临床无法控制的高血压 (6)心肌梗死病史 9. 对本方案任何药物的任何成分有过敏者 10. 不适合使用皮质类固醇者 11. 有活动性感染，且目前需要系统性抗感染治疗者 12. 免疫缺陷病史，包括HIV检测阳性，或患有其他获得性、先天性免 疫缺陷疾病，或有器官移植史 13. 随机前28天内参加过其他干预性药物临床试验者或同时参与另一 项临床试验或者使用其他研究性的治疗 14. 妊娠期（妊娠试验阳性）、哺乳期患者 15. 任何干扰治疗方案实施的其他合并疾病，或研究者认为受试者存 在其他严重的系统性疾病史、或其他原因而不宜参加本试验者

Exclusion criteria：

1. Stage IV metastatic breast cancer 2. Inflammatory breast cancer 3. Bilateral primary breast cancer (including invasive and in situ cancer) 4. Previous antitumor therapy or radiation therapy for any malignancy, excluding cervical carcinoma in situ, skin basal cell carcinoma, and squamous cell carcinoma that have been cured 5. Receive any sex hormone therapy (such as birth control pills, ovarian hormone replacement therapy, etc.), or any hormone medication (such as raloxifene, tamoxifen, or other selective estrogen receptor toner) for osteoporosis or breast cancer prevention 6. Patients who had undergone a major surgical procedure unrelated to breast cancer within 4 weeks prior to randomization or who had not Full recovery 7. CTCAE 5.0 grade evaluation for symptomatic peripheral neuropathy ≥ grade 2 8. Serious cardiovascular and cerebrovascular diseases, including but not limited to: A history of congestive heart failure or systolic dysfunction (LVEF<50%) (2) Angina pectoris requiring the use of anti-angina drugs (3) high-risk uncontrolled arrhythmias or severe conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, degree II-III atrioventricular block, etc.; At rest, the average QTcF of 3 12-lead electrocardiograms was >470ms (4) Clinically significant valvular heart disease with impaired heart function (5) Clinically uncontrollable hypertension (6) History of myocardial infarction 9. Allergic to any component of any drug in this program 10. People who are not suitable for corticosteroids 11. People with active infection who currently require systemic anti-infective treatment 12. History of immunodeficiency, including HIV positive test, or other acquired, congenital immunity Disease defects, or a history of organ transplantation 13. Participants who had participated in another interventional drug clinical trial or concurrently participated in another within 28 days prior to randomization A clinical trial or other investigational treatment 14. Pregnancy (pregnancy test positive), breastfeeding patients 15. Any other comorbidities that interfere with the implementation of the treatment regimen, or subjects with a history of other serious systemic diseases that the investigator deems unsuitable for participation in the study

研究实施时间：

Study execute time：

从 From 2025-03-15 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-03-20 00:00:00 至 To 2025-12-01 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

20

Group：

Experimental Group

Sample size：

干预措施：

泊沙康唑+新辅助化疗+PD-1抑制剂

干预措施代码：

Intervention：

Posaconazole combined with neoadjuvant chemotherapy and PD-1 inhibitors

Intervention code：

组别：

对照组

样本量：

20

Group：

Control group

Sample size：

干预措施：

新辅助化疗+PD-1抑制剂

干预措施代码：

Intervention：

Neoadjuvant chemotherapy and PD-1 inhibitors

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东 

市(区县)：

 济南 

Country：

China 

Province：

Shandong 

City：

Jinan 

单位(医院)：

山东第一医科大学附属肿瘤医院(山东省肿瘤医院 山东省肿瘤防治研究院) 

单位级别：

三甲 

Institution
hospital：

Cancer Hospital of Shandong First Medical University (Shandong Cancer institute, Shandong Cancer Hospital)

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

病理完全缓解

指标类型：

主要指标

Outcome：

Total pathological complete response

Type：

Primary indicator

测量时间点：

新辅助治疗术后

测量方法：

Measure time point of outcome：

Neoadjuvant therapy followed by surgery

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

Type：

Secondary indicator

测量时间点：

新辅助治疗术后

测量方法：

Measure time point of outcome：

Neoadjuvant therapy followed by surgery

Measure method：

指标中文名：

客观缓解率

指标类型：

主要指标

Outcome：

Objective response rate

Type：

Primary indicator

测量时间点：

新辅助治疗术后

测量方法：

Measure time point of outcome：

Neoadjuvant therapy followed by surgery

Measure method：

指标中文名：

3年无事件生存率

指标类型：

次要指标

Outcome：

3-year event-free survival rate

Type：

Secondary indicator

测量时间点：

中位随访3年后

测量方法：

Measure time point of outcome：

Median follow-up was 3 years

Measure method：

指标中文名：

生存率

指标类型：

次要指标

Outcome：

Survival 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：

安全性

指标类型：

次要指标

Outcome：

Security

Type：

Secondary indicator

测量时间点：

新辅助治疗术后

测量方法：

Measure time point of outcome：

Neoadjuvant therapy followed by surgery

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

肿瘤组织

组织：

乳腺，腋窝淋巴结

Sample Name：

Tumor tissue

Tissue：

Breast, Axillary lymph nodes

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：

血液

组织：

Sample Name：

Blood

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：

尿液

组织：

Sample Name：

Urine

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 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）：

全部受试者将采用分层区组随机分配到试验组或对照组，试验组和对照组比例为1:1 。分层因素：淋巴结转移阴性N0 vs 淋巴结转移阳性N1-3。由研究者借助SAS统计软件PROCPLAN过程语句，给定种子数，产生相应的随机表。对患者进行筛选期评估后，如果符合入排标准，研究者认为可以入组，则进入相应的随机系统，将受试者随机分配到试验组或对照组，并接受相应的治疗。

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

All subjects will be randomly assigned to the experimental group or the control group using stratified block randomization, with a 1:1 ratio between the experimental and control groups. Stratification factors: lymph node metastasis negative (N0) versus lymph node metastasis positive (N1-3). Researchers will use the SAS statistical software PROCPLAN process statement to generate the corresponding randomization table with a given seed number. After the patients undergo the screening phase assessment, if they meet the inclusion and exclusion criteria and the researcher considers them eligible for enrollment, they will enter the corresponding randomization system, where subjects will be randomly assigned to the experimental group or the control group, and receive the corresponding treatment.

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：

无

Blinding：

None

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：

1. 原始数据和原始文件 原始数据 原始数据是指通过临床发现、观察或试验中其他活动产生的原始记录和原始记录的合格副本中的全部信息，这些信息对于试验的复原和评价是必要的。原始数据包含在原始记录中。 原始记录 原始记录是指最早的文件、数据和记录（例如：医院记录、临床和办公室图 表、实验室记录、备忘录、受试者日记或评价表、药物发放记录、自动化仪器记 录的数据、验证后被认定为准确复印件的合格复印件或副本、微缩胶片、照相底片、微缩胶卷或磁介质、 X光、受试者档案以及参加临床试验的药房、实验室和医药技术部门保存的记录）。 临床试验特定原始数据定义 研究者必须保存受试者记录。 在特定原始记录中受试者病史、体格检查结果和其它临床相关结果、人口统计学数据和AE，然后转录到每个受试者的eCRF。实验室参数将从据中打印并粘贴原始记录中。实验室结果将由研究者转录到eCRF中。12导联ECG评估结果将被转录到eCRF的的特定部分，并且标注为正常、异常没有临床意义或异常有临床意义。必要时，还将在eCRF中对具体的异常情况进行详细描述。 2. eCRF eCRF是一个经验证的、符合所有法规要求数据管理系统，将按申办方指定的EDC系统进行设计。在试验过程中，将向研究心提供关于相应 eCRF填写的培训和帮助文本。eCRF将以电子的形式提交给申办方，应该根据指示进行处理。 所有eCRF都应该由受委派并经过培训的研究中心工作人员填写。研究者对录入到 eCRF中的所有临床数据采集和报告负最终责任。研究者或指定助理研究 者应审查 eCRF，并进行电子签名且注明日期以证实其正确性、真实性和完整性。 在研究结束时，研究者将收到一张载有其所的中心受试数据压缩光盘，该为可读格式必须与研究记录一同保存。研究者在收到压缩光盘后需提供回执。 已完成的 eCRF属于申办方的专有财产，如无事先书面许可，不应以任何形式提供给第三方，除非是经授权的申办代表或适当监管机构。 3. 数据管理 申办方将负责本研究的数据管理，包括数据的质量检查。手工输入的数据将通过使用eCRF在EDC中采集。研究中心负责将数据输入到EDC系统中。如果出现数据差异，申办方将要求研究中心作数据澄清，该研究中心可以在EDC系统中以电子的形式解决数据疑问。 申办方将监督本研究的数据管理。申办方将产生一份EDC研究规范文件，它描述了将对数据进行的质量检查。其它电子数据将按照申办方的或指定CRO的关于处理和传输这些电子数据标准程序，直接发送给申办方或指定的CRO。eCRF 及校正记录在EDC系统中将保留稽查痕迹。将按照申办方的标准程序对数据系统备份以及研究数据记录进行保存。

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

1. Original Data and Original Documents Original Data Original data refers to all information in the original records and qualified copies of the original records that are necessary for the reconstruction and evaluation of the trial. This data is contained within the original records. Original Records Original records refer to the earliest documents, data, and records (e.g., hospital records, clinical and office charts, laboratory records, memos, subject diaries or evaluation forms, drug distribution records, data recorded by automated instruments, qualified photocopies or duplicates verified as accurate copies, microfilm, photographic negatives, microfilm rolls or magnetic media, X-rays, subject files, and records kept by pharmacies, laboratories, and medical technology departments participating in the clinical trial). Clinical Trial Specific Original Data Definition Investigators must keep subject records. Subject medical history, physical examination results, and other clinically relevant results, demographic data, and AEs are recorded in specific original records and then transcribed to each subject's eCRF. Laboratory parameters will be printed from the data and pasted into the original records. Laboratory results will be transcribed to the eCRF by the investigator. 12-lead ECG assessment results will be transcribed to a specific section of the eCRF, marked as normal, abnormal without clinical significance, or abnormal with clinical significance. If necessary, specific abnormalities will also be described in detail in the eCRF. 2. eCRF eCRF is a validated, regulatory-compliant data management system designed according to the EDC system specified by the sponsor. During the trial, training and help texts regarding the completion of the corresponding eCRF will be provided to the research centers. eCRFs are submitted electronically to the sponsor and should be processed according to instructions. All eCRFs should be completed by research center staff who are delegated and trained. The investigator is ultimately responsible for all clinical data collection and reporting entered into the eCRF. The investigator or designated assistant investigator should review the eCRF, electronically sign it, and date it to certify its correctness, authenticity, and completeness. At the end of the study, the investigator will receive a compressed disc containing the subject data from their center, which must be saved together with the research records in a readable format. The investigator must provide an acknowledgment after receiving the compressed disc. Completed eCRFs are the proprietary property of the sponsor and should not be provided to any third party in any form without prior written permission, unless it is an authorized sponsor representative or appropriate regulatory authority. 3. Data Management The sponsor will be responsible for the data management of this study, including data quality checks. Manually entered data will be collected using eCRFs in the EDC. The research center is responsible for entering data into the EDC system. If there are data discrepancies, the sponsor will request data clarification from the research center, which can resolve data queries electronically in the EDC system. The sponsor will oversee the data management of this study. The sponsor will produce an EDC study specification document, which describes the quality checks that will be performed on the data. Other electronic data will be sent directly to the sponsor or designated CRO according to the sponsor's or designated CRO's standard procedures for handling and transmitting such electronic data. eCRFs and correction records will retain audit trails in the EDC system. Data systems will be backed up and research data records will be stored according to the sponsor's standard procedures.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-03-13 09:17:11