ChiCTR2500101370 版本V1.0 版本创建时间2025/04/24 09:16:13 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：

 ChiCTR2500101370 

最近更新日期：

Date of Last Refreshed on：

 2025-04-24 09:16:06 

注册时间：

Date of Registration：

 2025-04-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

利厄替尼联合贝伐珠单抗对比利厄替尼一线治疗EGFR突变且PD-L1高表达的局部晚期或复发转移非鳞NSCLC的疗效性和安全性的前瞻性、对照II期临床研究

Public title：

A prospective, controlled Phase II clinical study on the efficacy and safety of the combination of lerotinib and bevacizumab versus lerotinib monotherapy as first - line treatment for locally advanced or recurrent metastatic non - squamous NSCLC with EGFR mutations and high PD-L1 expression.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

利厄替尼联合贝伐珠单抗对比利厄替尼一线治疗EGFR突变且PD-L1高表达的局部晚期或复发转移非鳞NSCLC的疗效性和安全性的前瞻性、对照II期临床研究

Scientific title：

A prospective, controlled Phase II clinical study on the efficacy and safety of the combination of lerotinib and bevacizumab versus lerotinib monotherapy as first - line treatment for locally advanced or recurrent metastatic non - squamous NSCLC with EGFR mutations and high PD-L1 expression

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：

储天晴 

研究负责人：

储天晴 

Applicant：

Tianqing Chu 

Study leader：

Tianqing Chu 

申请注册联系人电话：

Applicant telephone：

 +86 21 22200000

研究负责人电话：

Study leader's
telephone：

+86 21 22200000

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：

 ctqxkyy@163.com

研究负责人电子邮件：

Study leader's E-mail：

 ctqxkyy@163.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：

上海市徐汇区淮海西路241号

研究负责人通讯地址：

上海市徐汇区淮海西路241号

Applicant address：

No. 241, Huaihai West Road, Xuhui District, Shanghai

Study leader's address：

No. 241, Huaihai West Road, Xuhui District, Shanghai

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：

上海市胸科医院

Applicant's institution：

Shanghai Chest Hospital

研究负责人所在单位：

上海市胸科医院

Affiliation of the Leader：

Shanghai Chest?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：

 IS25059

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：

上海市胸科医院伦理委员会

Name of the ethic committee：

Ehtics Committee of Shanghai Chest Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-03-31 00:00:00

伦理委员会联系人：

陈仲林

Contact Name of the ethic committee：

Carlos

伦理委员会联系地址：

上海市徐汇区淮海西路241号

Contact Address of the ethic committee：

No. 241, Huaihai West Road, Xuhui District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 21 22200000

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 chestgcp@126.com

研究实施负责（组长）单位：

上海市胸科医院

Primary sponsor：

Shanghai Chest?Hospital

研究实施负责（组长）单位地址：

上海市徐汇区淮海西路241号

Primary sponsor's address：

No. 241, Huaihai West Road, Xuhui District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海市胸科医院

具体地址：

上海市徐汇区淮海西路241号

Institution
hospital：

Shanghai Chest?Hospital

Address：

No. 241, Huaihai West Road, Xuhui District, Shanghai

经费或物资来源：

自筹

Source(s) of funding：

Self-raised funds

研究疾病：

携带 EGFR敏感突变且PD-L1高表达（CPS≥25%）的局部晚期或转移复发的非鳞NSCLC  

Target disease：

Locally advanced or metastatic recurrent non - squamous NSCLC with EGFR - sensitive mutations and high PD - L1 expression (CPS ≥ 25%).

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：

随机平行对照 

Study design：

Parallel 

研究目的：

携带EGFR突变且PD-L1高表达时，靶向治疗获益有限，且预后可能更差，免疫治疗或免疫联合靶向治疗也均因为疗效差、毒副反应高而被停用。靶向联合抗血管治疗显示出一定的治疗潜力，但仍需前瞻性临床研究的探索。故本研究旨在探索利厄替尼联合贝伐珠单抗对比利厄替尼单药在EGFR突变且PD-L1高表达非鳞NSCLC人群中一线治疗的疗效和安全性。  

Objectives of Study：

When EGFR - mutated and PD - L1 - high - expressing, targeted therapy has limited benefits and the prognosis may be worse. Immunotherapy or the combination of immunotherapy and targeted therapy has been discontinued due to poor efficacy and high toxicity. Targeted therapy combined with anti - angiogenic therapy has shown some therapeutic potential, but still needs to be explored in prospective clinical studies. Therefore, this study aims to explore the efficacy and safety of the combination of lerotinib and bevacizumab versus lerotinib monotherapy as first - line treatment in patients with EGFR - mutated and PD - L1 - high - expressing non - squamous NSCLC.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

合格入选本研究的受试者必须符合以下所有标准： 1. 在实施任何试验相关流程之前，签署书面知情同意； 2. 年龄≥18周岁； 3. 组织学或细胞学证实的非鳞状非小细胞肺癌； 4. 按照国际肺癌研究协会和美国癌症分类联合委员会第9版TNM肺癌分期的局部晚期（IIIB-IIIC）、转移或复发性（IV期）患者，不适合通过手术或放射治疗进行治疗； 5. 经肿瘤组织学或细胞学或血液学证实存在EGFR敏感突变（Ex19del、L858R）； 6. PD-L1表达CPS≥25%； 7. ECOG评分0-1分； 8. 既往未接受过抗血管生成抑制剂治疗或EGFR-TKI治疗； 9. 根据实体肿瘤疗效评价标准（RECIST v1.1版），至少有一处影像学可测量病灶。位于既往放疗照射野内的病灶如证实发生进展可视为可测量病灶； 10. 允许无症状或经局部治疗后症状稳定的脑转移受试者入组，只要受试者满足以下条件： 1) 中枢神经系统之外有可测量病灶 2) 无中枢神经系统症状或至少2周内症状无加重 3) 无需糖皮质激素治疗，或首次给药前7天内停用糖皮质激素治疗，或首次给药前7天内糖皮质激素用量稳定且减至10mg/天泼尼松（或等效剂量）以下。 11. 预期生存时间>3个月； 12. 足够器官功能，受试者需满足如下实验室指标： 1) 近14天未使用粒细胞集落刺激因子的情况下，中性粒细胞绝对值（ANC）≥1.5x10^9/L； 2) 近14天未输血的情况下，血小板≥100×10^9/L； 3) 近14天内无输血或使用促红细胞生成素的情况下，血红蛋白>9g/dL； 4) 总胆红素≤1.5×正常值上限（ULN）； 5) 天门冬氨酸转氨酶（AST）、丙氨酸转氨酶（ALT）在≤2.5×ULN（有肝转移的受试者允许ALT 或AST ≤5×ULN）； 6) 血肌酐≤1.5×ULN并且肌酐清除率（采用Cockcroft-Gault 公式计算）≥60 ml/min； 7) 凝血功能良好，定义为国际标准化比值（INR）或凝血酶原时间（PT）≤1.5倍ULN； 8) 甲状腺功能正常，定义为促甲状腺激素（TSH）在正常范围内。如基线TSH超出正常范围，如果总T3（或FT3）及FT4在正常范围内的受试者亦可入组； 9) 心肌酶谱在正常范围内（如研究者综合判断为不具有临床意义的单纯实验室异常也允许入组）； 13. 对于育龄期女性受试者，应在接受首次研究药物给药（第1周期第1天）之前的3天内接受尿液或血清妊娠试验且结果为阴性。如果尿液妊娠试验结果无法确认为阴性，则要求进行血液妊娠试验。非育龄期女性定义为绝经后至少１年，或进行过手术绝育或子宫切除术； 14. 如存在受孕风险，所有受试者（不论男性或女性）均需在整个治疗期间直至治疗末次研究药物给药后120天（或末次研究药物给药后180天）内采用年失败率低于1%的避孕措施。

Inclusion criteria

To be eligible for this study, subjects had to meet all of the following criteria: 1. Provided written informed consent before performing any trial-related procedures; 2. Age>=18 years old; 3. Non-squamous non-small cell lung cancer confirmed by histology or cytology; 4. According to the International Association for the Study of Lung Cancer and the American Joint Committee on Classification of Cancer 9th edition TNM stage of lung cancer, locally advanced (IIIB-IIIC), metastatic or recurrent (stage IV) patients are not suitable for treatment by surgery or radiotherapy; 5. The presence of EGFR sensitive mutations (Ex19del, L858R) confirmed by tumor histology or cytology or hematology; 6. PD-L1 expression CPS>=25%; 7. ECOG score 0-1; 8. No previous anti-angiogenesis inhibitor or EGFR-TKI therapy; 9. At least one radiographic measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST), version v1.1. Lesions within the previous irradiation field could be considered measurable if progression was confirmed. 10. Subjects with asymptomatic or symptomatic stable brain metastases after local treatment were allowed to participate as long as they met the following conditions: 1) measurable lesions outside the central nervous system 2) no central nervous system symptoms or worsening of symptoms for at least 2 weeks 3) no need for glucocorticoid therapy, glucocorticoids discontinued within 7 days before the first dose, or glucocorticoids that were stable and reduced to less than 10mg per day of prednisone (or the equivalent) within 7 days before the first dose. 11. Expected survival time >3 months; 12. Adequate organ function was defined as: 1) absolute neutrophil count (ANC) >=1.5x10^9/L without granulocyte colony-stimulating factor administration for the last 14 days; 2) platelet count >=100×10^9/L without blood transfusion in the past 14 days; 3) hemoglobin >9g/dL in the absence of blood transfusion or erythropoietin use in the past 14 days; 4) Total bilirubin <=1.5× upper limit of normal value (ULN); 5) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <=2.5×ULN (ALT or AST <=5×ULN were allowed for patients with liver metastasis); 6) serum creatinine <=1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) >=60 ml/min; 7) good coagulation function, defined as INR or PT <=1.5 times ULN; 8) Euthyroid, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH was beyond the normal range, the subjects could be included if the total T3 (or FT3) and FT4 were within the normal range. 9) Myocardial enzymes within the normal range (simple laboratory abnormalities that were judged by the investigators as not clinically significant were also allowed); 13. For women of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days prior to receiving the first dose of study drug (day 1 of cycle 1). If a urine pregnancy test result could not be confirmed as negative, a blood pregnancy test was requested. Women who were not of reproductive age were defined as those who had been postmenopausal for at least 1 year or had undergone surgical sterilization or hysterectomy. 14. If there was a risk of pregnancy, all subjects (male or female) were required to use contraception with an annual failure rate of less than 1% for the entire treatment period until 120 days (or 180 days) after the last dose of study drug.

排除标准：

符合以下标准的受试者不能入选本研究： 1. 病理为小细胞肺癌（SCLC），包括SCLC与NSCLC混合的肺癌； 2. 患者接受过任何的EGFR-TKI治疗或抗血管生成治疗； 3. 接受过以下治疗： 1) 治疗前3周内接受过全身性抗肿瘤治疗，如化疗、靶向治疗、免疫治疗（包括以抗肿瘤为适应症的中草药治疗）等； 2) 治疗前4周内接受过任何研究性药物治疗； 3) 治疗前4周内接受过大剂量免疫抑制药物（全身性糖皮质激素超过10mg/天泼尼松或其等效的剂量）； 4) 治疗前4周内接受过减毒活疫苗（或计划在研究期间接受减毒活疫苗）； 5) 治疗前4周内接受过大型手术（如开腔、开胸或凯富等手术），或未愈合的手术伤口、溃疡或骨折。 4. 存在临床上不可控制的胸腔积液/腹腔积液（不需要引流积液或停止引流3天积液无明显增加的受试者可以入组）； 5. 在治疗前6个月内接受过大于30Gy的胸部放射治疗或在治疗前7天内接受过30Gy及更小剂量的姑息性放射治疗的受试者（允许骨病变或颅内病变的姑息性放射治疗）； 6. 首次给药前2年内发生过需要全身性治疗（例如使用缓解疾病药物、糖皮质激素或免疫抑制剂）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糖皮质激素等）不视为全身性治疗； 7. 已知异体器官移植（角膜移植除外）或异体造血干细胞移植； 8. 已知对本研究药物贝伐珠单抗、利厄替尼活性成分或辅料过敏者； 9. 在开始治疗前，尚未从任何干预措施引起的毒性和/或并发症中充分恢复（即，≤1级或达到基线，不包括乏力或脱发）； 10. 已知人类免疫缺陷病毒（HIV）感染史（即HIV 1/2抗体阳性）； 11. 未经治疗的活动性乙肝（定义为HBsAg阳性同时检测到HBV-DNA拷贝数大于所在研究中心检验科正常值上限）； 注：符合下列标准的乙肝受试者亦可入组： 1) 首次给药前HBV病毒载量<1000拷贝/ml（200 IU/ml），受试者应在整个研究药物治疗期间接受抗HBV治疗避免病毒再激活 2) 对于抗HBc（+）、HBsAg（-）、抗HBs（-）和HBV病毒载量（-）的受试者，不需要接受预防性抗HBV治疗，但是需要密切监测病毒再激活 12. 活动性的HCV感染受试者（HCV抗体阳性且HCV-RNA水平高于检测下限）； 13. 首次给药之前（第1周期，第1天）30天内接种过活疫苗； 注：允许首次给药前30天内接受针对季节性流感的注射用灭活病毒疫苗；但是不允许接受鼻内用药的减毒活流感疫苗。 14. 妊娠或哺乳期妇女； 15. 存在任何严重或不能控制的全身性疾病，例如： 1) 静息心电图在节律、传导或形态上出现有重大且症状严重难以控制的异常，如完全性左束支传导阻滞，Ⅱ度以上心脏传导阻滞，室性心律失常或心房颤动； 2) 不稳定型心绞痛，充血性心力衰竭，纽约心脏病协会（NYHA）分级≥ 2 级的慢性心衰； 3) 入组前6个月内出现心肌梗死； 4) 血压控制不理想（收缩压＞140 mmHg，舒张压＞90 mmHg）； 5) 首次给药前1年内存在需要糖皮质激素治疗的非感染性肺炎病史，或当前存在临床活动性间质性肺病； 6) 活动性肺结核； 7) 存在需要全身性治疗的活动性或未能控制的感染； 8) 存在临床活动性憩室炎、腹腔脓肿、胃肠道梗阻； 9) 肝脏疾病如肝硬化、失代偿性肝病、急性或慢性活动性肝炎； 10) 糖尿病控制不佳（空腹血糖（FBG）＞10mmol/L）； 11) 尿常规提示尿蛋白≥++，且证实24小时尿蛋白定量＞1.0 g者； 12) 存在精神障碍且无法配合治疗的受试者； 16. 有可能干扰试验结果、妨碍受试者全程参与研究的病史或疾病证据、治疗或实验室检查值异常，或研究者认为其他不适合入组的情况研究者认为存在其他潜在风险不适合参加本研究。

Exclusion criteria：

Subjects who met the following criteria were not eligible for inclusion in the study: 1. Small cell lung cancer (SCLC), including SCLC and NSCLC mixed lung cancer; 2. Patients had received any EGFR-TKI therapy or anti-angiogenic therapy; 3. Received the following treatments: 1) received systemic anti-tumor therapy within 3 weeks before treatment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal medicine for anti-tumor indications), etc.; 2) received any investigational drug within 4 weeks before treatment; 3) receipt of high-dose immunosuppressive drugs (systemic corticosteroids more than 10mg/ day of prednisone or its equivalent) within 4 weeks before treatment; 4) received a live attenuated vaccine within 4 weeks before treatment (or planned to receive a live attenuated vaccine during the study); 5) major surgery (such as open thoracotomy, thoracotomy, or Capf) or unhealed surgical wounds, ulcers, or fractures within 4 weeks before treatment. 4. Patients with clinically uncontrollable pleural effusion/peritoneal effusion (patients who did not require drainage or had no significant increase in effusion after 3 days of cessation of drainage could be enrolled); 5. Patients who received thoracic radiotherapy of more than 30Gy within 6 months prior to treatment or palliative radiotherapy of 30Gy or less within 7 days prior to treatment (palliative radiotherapy for bone or intracranial lesions was allowed); 6. Active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, glucocorticoids, or immunosuppressive agents) occurred within 2 years before the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) were not considered systemic therapy; 7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Known to be allergic to the active ingredients or excipients of bevacizumab and riertinib; 9. Has not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., grade <=1 or baseline, excluding fatigue or alopecia); 10. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 11. Untreated active hepatitis B (defined as both HBsAg positivity and HBV-DNA copies greater than the upper limit of normal in the laboratory at the participating center); Note: Subjects with hepatitis B who met the following criteria were also eligible for inclusion: 1) Subjects with HBV viral load <1000 copies /ml (200 IU/ml) before the first dose should receive anti-HBV therapy throughout the study drug treatment to avoid viral reactivation. 2) For subjects with anti-HBc (+), HBsAg (-), anti-hbs (-) and HBV viral load (-), Prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is required 12. Active HCV-infected subjects (HCV-antibody positive and HCV-RNA level above the lower limit of detection); 13. A live vaccine dose within 30 days before the first dose (cycle 1, day 1); Note: Administration of injectable inactivated virus vaccine against seasonal influenza within 30 days before the first dose is allowed; Live, attenuated, intranasal influenza vaccine was not allowed. 14. Pregnant or lactating women; 15. The presence of any serious or uncontrolled systemic disease, such as: 1) significant rhythm, conduction or morphological abnormalities in resting ECG, such as complete left bundle branch block, >= degree II heart block, ventricular arrhythmia or atrial fibrillation; 2) unstable angina, congestive heart failure, New York Heart Association (NYHA) grade >= 2 chronic heart failure; 3) myocardial infarction within 6 months before enrollment; 4) poor blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 5) patients had a history of noninfectious pneumonia requiring glucocorticoid treatment within 1 year before the first dose of glucocorticoid, or current clinically active interstitial lung disease; 6) active pulmonary tuberculosis; 7) presence of active or uncontrolled infection requiring systemic therapy; 8) presence of clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; 9) liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 10) poorly controlled diabetes (fasting blood glucose (FBG) > 10mmol/L); 11) Urine routine test showed urinary protein >=++ and confirmed 24-hour urinary protein quantitation > 1.0 g; 12) subjects with a mental disorder who are unable to cooperate with treatment; 16. Medical history or evidence of disease, treatment or laboratory abnormalities, or other conditions deemed by the investigator to be inappropriate for enrollment that may interfere with the results of the trial, prevent the participant from participating in the study fully.

研究实施时间：

Study execute time：

从 From 2025-05-15 00:00:00至 To 2028-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-05-15 00:00:00 至 To 2026-11-15 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 68

Group：

Experimental group

Sample size：

干预措施：

利厄替尼联合贝伐珠单抗

干预措施代码：

Intervention：

The combination of Limertinib and bevacizumab.

Intervention code：

组别：

对照组

样本量：

 68

Group：

Control Group

Sample size：

干预措施：

利厄替尼

干预措施代码：

Intervention：

Limertinib

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China

Province：

Shanghai

City：

单位(医院)：

 上海市胸科医院 

单位级别：

 三甲 

Institution
hospital：

Shanghai Chest Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

客观缓解率

指标类型：

次要指标

Outcome：

Objective response rate, ORR

Type：

Secondary indicator

测量时间点：

每6周±7天一次

测量方法：

采用RECIST v1.1进行临床肿瘤影像学评价

Measure time point of outcome：

Every 6 weeks ± 7 days

Measure method：

Clinical tumor imaging evaluation is conducted using RECIST v1.1.

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：

每6周±7天一次

测量方法：

本研究过程中和随访期间将根据NCI CTCAE（5.0版）对不良事件的严重程度进行分级评估

Measure time point of outcome：

Every 6 weeks ± 7 days

Measure method：

The severity of adverse events will be graded according to the NCI CTCAE (version 5.0) during the study and follow - up period.

指标中文名：

无进展生存期

指标类型：

主要指标

Outcome：

Progression-free survival, PFS

Type：

Primary indicator

测量时间点：

每6周±7天一次

测量方法：

采用RECIST v1.1进行临床肿瘤影像学评价

Measure time point of outcome：

Every 6 weeks ± 7 days

Measure method：

Clinical tumor imaging evaluation is conducted using RECIST v1.1.

指标中文名：

总生存期

指标类型：

次要指标

Outcome：

Overall survival, OS

Type：

Secondary indicator

测量时间点：

每6周±7天一次

测量方法：

采用RECIST v1.1进行临床肿瘤影像学评价

Measure time point of outcome：

Every 6 weeks ± 7 days

Measure method：

Clinical tumor imaging evaluation is conducted using RECIST v1.1.

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 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）：

由EDC系统中的随机系统进行随机

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

Randomization is performed by the randomization system in the EDC (Electronic Data Capture) system.

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：

开放标签

Blinding：

Open-label study

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）：

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：

电子采集和管理系统

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

Electronic Data Capture, EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-04-24 09:16:06