ChiCTR2500100687 版本V1.0 版本创建时间2025/04/14 10:51:55 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：

ChiCTR2500100687 

最近更新日期：

Date of Last Refreshed on：

2025-04-14 10:51:41 

注册时间：

Date of Registration：

2025-04-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

双侧胸腔淋巴结清扫在N3非小细胞肺癌免疫治疗后缓解病人中的应用

Public title：

The application of bilateral thoracic lymph node dissection in patients with N3 non-small cell lung cancer after immunotherapy remission.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

双侧胸腔淋巴结清扫在N3非小细胞肺癌免疫治疗后缓解病人中的应用

Scientific title：

The application of bilateral thoracic lymph node dissection in patients with N3 non-small cell lung cancer after immunotherapy remission.

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：

邓汉宇 

研究负责人：

朱大兴 

Applicant：

Hanyu Deng 

Study leader：

Daxing Zhu 

申请注册联系人电话：

Applicant telephone：

+86 182 0029 5920

研究负责人电话：

Study leader's telephone：

+86 189 8060 1801

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：

hanyudeng@scu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

zhuda200023@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

华西临床医学院

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：

四川省成都市国学巷37号

研究负责人通讯地址：

四川省成都市国学巷37号

Applicant address：

No. 37, Guoxue Lane, Chengdu, Sichuan Province

Study leader's address：

No. 37, Guoxue Lane, Chengdu, Sichuan Province

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：

四川大学华西医院

Applicant's institution：

West China Hospital, Sichuan University

研究负责人所在单位：

四川大学华西医院

Affiliation of the Leader：

West China Hospital, Sichuan University

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：

2023年审(2097)号

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：

四川大学华西医院生物医学伦理委员会

Name of the ethic committee：

Ethics Committee of West China Hospital, Sichuan University.

伦理委员会批准日期：

Date of approved by ethic committee：

2024-02-29 00:00:00

伦理委员会联系人：

邓绍林

Contact Name of the ethic committee：

Shaolin Deng

伦理委员会联系地址：

四川省成都市国学巷37号

Contact Address of the ethic committee：

No. 37, Guoxue Lane, Chengdu, Sichuan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 28 8542 2851

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：

四川大学华西医院

Primary sponsor：

West China Hospital, Sichuan University

研究实施负责（组长）单位地址：

四川省成都市国学巷37号

Primary sponsor's address：

No. 37, Guoxue Lane, Chengdu, Sichuan 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)：

四川

市(区县)：

成都

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

四川大学华西医院

具体地址：

中国四川省成都市国学巷37号

Institution
hospital：

West China Hospital, Sichuan University

Address：

No. 37, Guoxue Lane, Chengdu, Sichuan Province

经费或物资来源：

华西医院临床新技术基金（医临新2023-271）

Source(s) of funding：

West China Hospital Clinical New Technology Fund (Yilinxin 2023-271)

Target disease：

Non-small cell lung 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：

单臂 

Study design：

Single arm 

研究目的：

1.探索手术在N3非小细胞肺癌多学科治疗中的作用； 2.探究双侧胸腔淋巴结清扫术在N3非小细胞肺癌患者中的安全性和有效性； 3.探索新辅助免疫治疗联合双侧胸腔手术和术后辅助免疫治疗的创新治疗模式在N3非小细胞肺癌的价值和意义  

Objectives of Study：

1. Explore the role of surgery in the multidisciplinary treatment of N3 non-small cell lung cancer; 2. Investigate the safety and efficacy of bilateral thoracic lymph node dissection in patients with N3 non-small cell lung cancer; 3. Explore the value and significance of an innovative treatment model combining neoadjuvant immunotherapy with bilateral thoracic surgery and postoperative adjuvant immunotherapy in N3 non-small cell lung 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：

入选标准 1.能够提供书面知情同意书，并且能理解并同意依从本项研究的要求以及评估时间表。 2.签署知情同意书之日已年满 18 周岁且小于70周岁（通过EBUS活检后组织学证实为 N3 IIIB、IIIC 期非小细胞肺癌 分期应基于第 8 版美国癌症联合委员会/国际抗癌联盟非小细胞肺癌分期体系。临床分期T1-4N3M0的患者入组：T1：肿瘤最大径<=3cm, 周围包绕肺组织及脏层胸膜，支气管镜见肿瘤位于叶支气管开口远端，未侵及主支气管；T2：肿瘤最大径>3cm, <=5cm；侵犯主支气管，但未侵及隆突；侵及脏层胸膜；有阻塞性肺炎或者部分或全肺不张。 T3: 肿瘤最大径>5cm, <=7cm；侵及以下任何一个器官，包括：胸壁、膈神经、心包；同一肺叶出现孤立性癌结节。 T4：肿瘤最大径>7cm；无论大小，侵及以下任何一个器官，包括：纵膈、心脏、大血管、隆突、喉返神经、主气管、食管、椎体、膈肌；同侧不同肺叶出现孤立癌结节。N3：转移到对侧纵隔淋巴结。 3. 在行计划切除前 6个月内将对患者进行肺功能测试，如有临床指征，可在筛选时再次测试，测试指标包括肺容量、呼吸肺活量测定和扩散能力。如果肺功能测试结果有异常，可通过定量通气/灌注扫描或心肺运动测试做进一步评估。术后需进行一秒用力呼吸容量预测用力呼气量百分比（FEV1）和扩散能力检查，预测的百分比必须为>=40%，和/或最大耗氧量（VO2max）应为>= 10 分比（FEV1）和扩散能力检查，预测的百分比必须为>=40%，和/或最大耗氧量（VO2max）应为>= 10 mL/kg/分钟。 4. 心脏功能良好，确认符合出于根治性治疗的目的进行手术切除的要求。 a.如果有临床指征，心脏病专家应在术前评估患者是否有缺血性、瓣膜性或有其他重大心脏病等基础疾病。 5. 研究者根据 RECIST 1.1 版评估为可测量疾病。 6. ECOG体能状态为0或 1。 7. 筛选过程中或入组前<=14天，以下筛选期实验室检查值提示患者的器官功能良好： a.在筛选期检测以下项目时，患者在抽血前<=14天内没有输血或使用生长因子支持治疗：中性粒细胞绝对计数>=1.5x10^9/L，血小板>=75×10^9/L，血红蛋白>=90g/L； b.慢性肾病流行病学协作方程估算的肾小球滤过率（GFR）>=45mL/min/1.73 m2，计划接受卡铂的患者：GFR >=45 mL/min。 c.血清总胆红素<=1.5×正常值上限（ULN）（Gilbert’s 综合征患者的总胆红素必须＜3×ULN）。AST 和 ALT<=2.5×ULN。 d.没有接受抗凝治疗的患者：国际标准化比或活化部分促凝血酶原时间<=1.5×ULN 8. 治疗前NGS结果显示驱动基因EGFR、ALK、ROS-1阴性。

Inclusion criteria

Inclusion Criteria 1. Able to provide written informed consent, and can understand and agree to comply with the requirements of this study as well as the evaluation schedule. 2. Have been at least 18 years old and less than 70 years old on the date of signing the informed consent form (confirmed by histology after EBUS biopsy for N3 IIIB, IIIC stage non-small cell lung cancer Staging should be based on the 8th edition of the American Joint Committee on Cancer/International Union Against Cancer (IUC) NSCLC staging system. Patients with clinical stage T1-4N3M0 were enrolled: T1: the maximum diameter of the tumor was <=3cm, surrounded by lung tissue and visceral pleura, and bronchoscopy showed that the tumor was located at the distal end of the lobe bronchial opening and did not invade the main bronchus; T2: maximum tumor diameter>3cm, <=5cm; invasion of the main bronchus, but not of the carina; invasion of the visceral pleura; Have obstructive pneumonia or partial or total atelectasis. T3: Maximum tumor diameter>5cm, <=7cm; Invasion of any of the following organs, including: chest wall, phrenic nerve, pericardium; Solitary cancerous nodules in the same lobe. T4: maximum tumor diameter>7cm; Regardless of size, it affects any of the following organs, including: mediastinum, heart, large vessels, carina, recurrent laryngeal nerve, main trachea, esophagus, vertebral body, diaphragm; Solitary cancerous nodules in different lobes of the same side. N3: metastasis to contralateral mediastinal lymph nodes. 3. Patients will be tested for pulmonary function within 6 months prior to planned resection, and can be retested at screening if clinically indicated, with test indicators including lung volume, respiratory spirometry and diffusion capacity. If pulmonary function tests are abnormal, further evaluation can be done with quantitative ventilation/perfusion scans or cardiopulmonary exercise testing. Postoperatively, a one-second forced respiratory volume predicted percent forced expiratory volume (FEV1) and diffusion capacity test must be performed with a predicted percentage of >=40%, and/or maximum oxygen consumption (VO2max) of > = 10 points ratio (FEV1) and a diffusion capacity test, with a predicted percentage of >=40%, and/or a maximum oxygen consumption (VO2max) of >= 10 mL/kg/min. 4. Cardiac function is good, and it is confirmed that surgical resection for the purpose of curative treatment is met. a. If clinically indicated, a cardiologist should evaluate the patient for an underlying disease such as ischemic, valvular or other major cardiac disease before surgery. 5. Measurable disease as assessed by the investigator according to RECIST version 1.1. 6. ECOG performance status of 0 or 1. 7. During the screening process or <=14 days before enrollment, the following laboratory test values during the screening period indicate that the patient's organ function is good: a. Patients have no blood transfusion or use of growth factor supportive therapy within <=14 days prior to blood draw: absolute neutrophil count > = 1.5x10^9/L, platelet > = 75×10^9/L, hemoglobin > = 90 g/L when the following items are tested during the screening period; b. Glomerular filtration rate (GFR) estimated by the Cooperative Equation of Epidemiology of Chronic Kidney Disease >=45mL/min/1.73 m2, patients who planned to receive carboplatin: GFR >=45 mL/min. c. Serum total bilirubin < = 1.5 × upper limit of normal (ULN) (total bilirubin must be <3×ULN in patients with Gilbert's syndrome). AST and ALT<=2.5×ULN. d. Patients without anticoagulant therapy: international normalized ratio or activated partial prothrombin time <=1.5×ULN 8. Pre-treatment NGS results showed negative driver genes EGFR, ALK, ROS-1.

排除标准：

排除标准 1.之前曾针对当前所患肺癌进行过任何治疗，包括靶向、免疫、化疗或放疗。 2.活动性自身免疫性疾病或可能复发的自身免疫性疾病病史。 注：患有以下疾病的患者不需要排除，而且可继续进行进一步筛选： 控制良好的I型糖尿病 甲状腺功能减退症（只要单纯采用激素替代疗法进行治疗） 控制良好的乳糜泻 不需要全身性治疗的皮肤疾病（例如白癜风、银屑病、脱发） 没有外部触发因素的情况下预期不会复发的任何其他疾病 3.入组分组前≤2年曾罹患任何活动期恶性肿瘤，除了本研究中研究的特定癌症和已经行根治治疗后局部复发的癌症（例如，已切除的基底细胞或鳞状细胞皮肤癌、浅表膀胱癌、宫颈或乳腺原位癌）4.在入组化前≤14天内里罹患过需要使用皮质类固醇（泼尼松或同等药物的剂量＞10mg/天）或其他免疫抑制药物进行全身治疗的任何病症。 注：目前或既往使用过以下任何类固醇治疗方案的患者不必排除： 肾上腺替代类固醇（泼尼松或同等药物的剂量＞10mg/天） 局部、眼部、关节内、鼻内或吸入用皮质类固醇，全身吸收量极低 短期（<=7 天）预防性使用皮质类固醇（例如造影剂过敏）或用于治疗非自身免疫性疾病（例如接触性过敏原引起的迟发型超敏反应） 5.入组分组前≤14内前患有控制不佳的糖尿病，或钾、钠或校正钙＞1级的实验室检查结果异常（不考虑是否采用标准医疗管理）或≥3级低白蛋白血症。 6.有间质性肺病史、非感染性肺炎或控制不佳的疾病，包括肺纤维化、急性肺病等。 7.严重慢性或活动性感染，需要全身抗菌、抗真菌或抗病毒治疗，包括结核感染等。 入组化前4周内发生严重感染，包括但不限于因感染、菌血症或重症肺炎并发症住院治。 入组分组前2周接受过口服或静脉注射抗生素治疗。 8.已知有 HIV 病毒感染史。 9.未治疗的慢性乙型肝炎患者或乙肝病毒（ HBV）DNA>=500IU/mL的 HBV携带者、或携带活动性丙型肝炎病毒（ HCV）的患者应排除。 注：非活动性乙型肝炎表面抗原（HBsAg）携带者，经治疗且稳定的乙型肝炎患携带者（ HBV DNA <500 IU/mL），已治愈的丙型肝炎患者可以入组。 10.若入组分组前<=28天内进行过需要全身麻醉的任何大型外科手术。 11.既往进行过异体干细胞移植或器官移植。 12.以下任意一项心血管风险因素： 入组分组前28天内（含）发生过心源性胸痛，定义为工具性日常生活活动受限的中度疼痛。 入组分组前28天内（含）发生过症状性肺栓塞。 入组分组前6个月内（含）有任何急性心肌梗塞病史。 入组分组前≤6个月有任何符合纽约心脏协会分类III或 IV级的心力衰竭病史。 入组分组前6个月内（含）发生过任何>=2级的室性心律失常事件 。 入组分组前6个月内（含）有任何脑血管意外病史。 在入组化前28天内使用标准降压药物治疗仍然无法控制的高血压。 入组化前<=28天出现过晕厥或癫痫发作。 13.毒副作用（由于既往抗肿瘤治疗）未恢复到基线或稳定水平的患者，除非不认为这种AE 可能带来安全性风险（例如脱发、神经病和特定实验室异常）。 14.入组分组前<=4周内接种过活体疫苗。注：季节性注射的流感疫苗通常是灭活疫苗，因此允许使用。鼻内接种疫苗属于活体疫苗，所以不允许使用。 15.存在研究者认为不利于研究药物给药或影响药物毒性或不良事件解读的基本医学状况（包括实验室异常）或酒精/药物滥用或依赖，或者研究者判断该患者在研究期间的依从性不够会可能使依从性受影响的情况。

Exclusion criteria：

Exclusion Criteria: 1. Previous treatment for current lung cancer, including targeted, immunotherapy, chemotherapy, or radiotherapy. 2. Active autoimmune disease or history of autoimmune disease that may recur. Note: Patients with the following conditions do not need to be excluded and can proceed for further screening: Well-controlled type I diabetes Hypothyroidism (as long as it is treated with hormone replacement therapy alone) Well-controlled celiac disease Skin conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, alopecia) Any other disease that is not expected to recur in the absence of an external trigger 3. < = 2 years of any active malignancy prior to enrollment, except for the specific cancer studied in this study and the cancer that has recured locally after radical therapy (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ) 4. Any condition requiring systemic treatment with corticosteroids (prednisone or equivalent> 10 mg/day) or other immunosuppressive drugs within <=14 days prior to enrollment. Note: Patients with current or prior use of any of the following steroid regimens do not need to be excluded: Adrenal replacement steroids (prednisone or equivalent> 10 mg/day) Topical, ocular, intra-articular, intranasal, or inhaled corticosteroids with very low systemic absorption Short-term (<=7 days) prophylactic use of corticosteroids (e.g., contrast allergy) or for the treatment of non-autoimmune diseases (e.g., delayed-type hypersensitivity reactions due to contact allergens) 5. Poorly controlled diabetes mellitus within <=14 years before enrollment, or abnormal laboratory test results of potassium, sodium or calibrated calcium > grade 1 (regardless of whether standard medical management is used) or >= Grade 3 hypoalbuminemia. 6. Have a history of interstitial lung disease, non-infectious pneumonia, or poorly controlled diseases, including pulmonary fibrosis, acute lung disease, etc. 7. Severe chronic or active infection requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. Severe infection within 4 weeks prior to enrollment, including but not limited to hospitalization for infection, bacteremia or complications of severe pneumonia. Received oral or intravenous antibiotic therapy 2 weeks prior to enrollment. 8. Known history of HIV virus infection. 9. Patients with untreated chronic hepatitis B or HBV carriers with hepatitis B virus (HBV) DNA >=500IU/mL, or patients with active hepatitis C virus (HCV) should be excluded. Note: Patients with inactive hepatitis B surface antigen (HBsAg), treated and stable hepatitis B carriers (HBV DNA <500 IU/mL), and cured hepatitis C patients can be enrolled. 10. If any major surgical procedure requiring general anesthesia has been performed within <=28 days prior to enrollment in the group. 11. Previous allogeneic stem cell transplantation or organ transplantation. 12. Any of the following cardiovascular risk factors: Cardiogenic chest pain within 28 days prior to enrollment (inclusive), defined as moderate pain with instrumental limitation of activities of daily living. Symptomatic pulmonary embolism within 28 days (inclusive) prior to enrollment. Any history of acute myocardial infarction within 6 months (inclusive) prior to enrollment grouping. Any history of heart failure consistent with New York Heart Association classification class III or IV <=6 months prior to enrollment grouping. Any >=2 grade ventricular arrhythmia event within 6 months prior to enrollment (inclusive). Any history of cerebrovascular accident within 6 months (inclusive) prior to enrollment in the group. Treatment of hypertension that remains uncontrolled with standard antihypertensive medications within 28 days prior to enrollment. Syncope or seizures <=28 days prior to enrollment. 13. Patients who have not returned to baseline or stable levels of toxic side effects (due to prior antineoplastic therapy), unless such AEs are not considered to pose a safety risk (e.g., alopecia, neuropathy, and specific laboratory abnormalities). 14. < = 4 weeks of live vaccination before enrollment in the group. Note: Seasonal influenza vaccines are usually inactivated and are therefore permitted. Intranasal vaccination is a live vaccine, so it is not allowed. 15. Presence of an underlying medical condition (including laboratory abnormalities) or alcohol/drug abuse or dependence that, in the opinion of the investigator, is detrimental to the administration of the study drug or affects the interpretation of drug toxicity or adverse events, or in the judgment of the investigator that the patient's adherence during the study is not adequate that may affect compliance.

研究实施时间：

Study execute time：

从 From 2024-12-01 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-04-14 00:00:00 至 To 2026-12-31 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

10

Group：

Experimental group

Sample size：

干预措施：

新辅助方案：化疗方案为：若病理类型为鳞癌，则采用白蛋白紫杉醇（200mg/m2）加顺铂（75mg/m2），若病理类型是非鳞癌，则采用培美曲塞（500mg/m2）加顺铂（75mg/m2），免疫治疗方案替雷丽珠单抗（200mg），每三周一次，共3-4周期。免疫单药方案为：免疫治疗方案为替雷丽珠单抗（200mg），每三周一次，共6-8周期；免疫单药方案的目的是筛选对免疫治疗敏感的病人。手术方案为（免疫单药治疗结束4周内）：对侧胸腔行胸腔镜纵隔淋巴结清扫，病灶侧胸腔尽可能行胸腔镜肺切除术加系统性淋巴结清扫术。先行对侧胸腔胸腔镜纵隔淋巴结清扫术时，若发现闭锁胸腔、严重致密粘连，则手术终止，行辅助治疗。术后辅助治疗（术后4-6周内）：免疫治疗方案为替雷丽珠单抗（200mg），每三周一次，维持治疗2年。

干预措施代码：

Intervention：

New adjuvant regimen: Chemotherapy regimen: If the pathological type is squamous cell carcinoma, albumin paclitaxel (200mg/m2) plus cisplatin (75mg/m2) is used. If the pathological type is non squamous cell carcinoma, pemetrexed (500mg/m2) plus cisplatin (75mg/m2) is used. Immunotherapy regimen: Trastuzumab (200mg), once every three weeks, for a total of 3-4 cycles. The immunotherapy regimen is: the immunotherapy regimen is Trastuzumab (200mg), once every three weeks for 6-8 cycles; The purpose of the immunotherapy monotherapy regimen is to screen patients who are sensitive to immunotherapy. The surgical plan is (within 4 weeks after the end of immunotherapy): thoracoscopic mediastinal lymph node dissection is performed on the contralateral chest cavity, and thoracoscopic lung resection and systematic lymph node dissection are performed on the affected side of the chest cavity as much as possible. When performing thoracoscopic mediastinal lymph node dissection on the opposite side first, if locked chest cavity and severe dense adhesions are found, the surgery is terminated and adjuvant therapy is performed. Postoperative adjuvant therapy (within 4-6 weeks after surgery): The immunotherapy regimen is Trastuzumab (200mg), administered every three weeks, and maintained for 2 years.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

 成都 

Country：

China 

Province：

Sichuan 

City：

Chengdu 

单位(医院)：

四川大学华西医院 

单位级别：

三甲 

Institution
hospital：

West China Hospital, Sichuan University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

30天内术后并发症发生率

指标类型：

主要指标

Outcome：

Incidence of postoperative complications within 30 days

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后病理pCR率

指标类型：

次要指标

Outcome：

Postoperative pathological pCR 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：

30天内死亡率

指标类型：

主要指标

Outcome：

Mortality within 30 days

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后病理MPR率

指标类型：

次要指标

Outcome：

Postoperative pathological MPR rate

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：

肺癌组织

Sample Name：

Blood

Tissue：

Tumor 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 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:

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：

CRF;EDC

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

CRF;EDC

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：

  2025-04-14 10:51:41