Chinese Clinical Trial Register (ChiCTR) - The world health organization international clinical trials registered organization registered platform

注册号： Registration number：	ChiCTR2400094918
最近更新日期： Date of Last Refreshed on：	2024-12-30 16:14:14
注册时间： Date of Registration：	2024-12-30 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	重组人血管内皮抑制素联合曲拉西利、紫杉醇、卡铂及抗PD-(L)1一线治疗晚期（IIIB-IV期）鳞状非小细胞肺癌的研究
Public title：	A prospective, single-arm, phase II clinical study of recombinant human endostatin in combination with trilaciclib, paclitaxel, carboplatin, and anti-PD-(L)1 as first-line treatment for advanced (stage IIIB-IV) squamous non-small cell lung cancer
注册题目简写：
English Acronym：
研究课题的正式科学名称：	重组人血管内皮抑制素联合曲拉西利、紫杉醇、卡铂及抗PD-(L)1一线治疗晚期（IIIB-IV期）鳞状非小细胞肺癌的前瞻性、单臂II期临床研究
Scientific title：	A prospective, single-arm, phase II clinical study of recombinant human endostatin in combination with trilaciclib, paclitaxel, carboplatin, and anti-PD-(L)1 as first-line treatment for advanced (stage IIIB-IV) squamous non-small cell lung 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：	逯海娇	研究负责人：	储天晴
Applicant：	Haijiao Lu	Study leader：	Tianqing Chu
申请注册联系人电话： Applicant telephone：	+86 18538210177	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：	luhj1989@126.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：	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/Yes
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	IS24126	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：	2024-09-05 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：	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：

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：	241 Huaihai West Road, Xuhui District, Shanghai

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

China International Medical Exchange Foundation

Target disease：

Advanced squamous 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：

II期临床试验

Study phase：

2

研究设计：

单臂

Study design：

Single arm

研究目的：

本研究旨在探索抗PD-(L)1免疫治疗联合标准紫杉醇/卡铂方案、重组人血管内皮抑制素以及曲拉西利一线治疗晚期（IIIB-IV期）鳞状NSCLC，旨在评估其疗效和安全性，通过与目前标准一线治疗方案进行初步疗效和安全性对比，将有可能为晚期鳞状非小细胞肺癌的一线治疗提供新的、潜在的治疗选择，从而改善患者预后，提高生存质量。

Objectives of Study：

The aim of this study is to explore the efficacy and safety of anti-PD - (L) 1 immunotherapy combined with standard paclitaxel/carboplatin regimen, recombinant human endostatin, and Trilaciclib as first-line treatment for advanced (stage IIIB-IV) squamous NSCLC. By comparing its efficacy and safety with current standard first-line treatment regimens, it may provide new and potential treatment options for first-line treatment of advanced squamous non-small cell lung cancer, thereby improving patient prognosis and enhancing quality of life.

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≥18周岁； 2. 根据国际肺癌研究协会和美国癌症分类联合委员会第8版肺癌TNM分期分类，具有组织学或细胞学证实的不能手术治疗且不能接受根治性同步放化疗的局部晚期（IIIB/IIIC期）、转移性或复发性（IV期）鳞状 NSCLC的患者； 3. 根据实体肿瘤疗效评价标准（RECIST 1.1版），至少有一处影像学可测量病灶； 4. 东部肿瘤协作组（ECOG）体能状态评分为0-1； 5. 既往未接受过针对晚期/转移性疾病的任何系统性抗肿瘤治疗。对于既往曾接受过含铂辅助/新辅助化疗，或针对进展期疾病接受过根治性放化疗的患者，如疾病进展或复发与末次化疗药物治疗结束间隔至少6个月以上，允许入组本研究； 6. 预期生存时间>3个月； 7. 具有充分的器官和骨髓功能，入组前7天内实验室检查值符合下列要求(获得实验室检查的前14天内不允许给予任何血液成分、细胞生长因子、白蛋白及其他纠正治疗的药物)，具体如下： 1）血常规：中性粒细胞绝对计数（ANC）≥1.5×109/L，血小板（PLT）≥75×109/L，血红蛋白（HGB）≥90 g/L（14日内无输血或无促红细胞生成素依赖性） 2）肝功能：血清总胆红素（TBIL）≤2倍正常上限（ULN）；丙氨酸氨基转移酶（ALT）和/或天门冬氨酸氨基转移酶（AST）≤5倍ULN，血清白蛋白≥28 g/L；碱性磷酸酶（alkaline phosphatase, ALP≤5×ULN。 3）肾功能：血清肌酐（Cr）≤1.5×ULN，或肌酐清除率≥50 mL/min（应用标准的 Cockcroft-Gault公式）：尿常规结果显示尿蛋白＜2+；对基线时尿常规检测显示尿蛋白≥2+的患者，应进行24小时尿液采集且24小时尿蛋白定量＜1g。 4）凝血功能：国际标准化比值（INR）或凝血酶原时间（PT）≤1.5倍ULN；若受试者正接受抗凝治疗，只要INR在抗凝药物拟定的使用范围内即可。 8.对于育龄期女性受试者，应在接受首次研究药物给药之前的3天进行尿液或血清妊娠试验且结果为阴性； 9. 受试者与受试者性伴侣需要在研究治疗期间和研究治疗期结束后6个月内采用一种经医学认可的避孕措施（如宫内节育器，避孕药或避孕套等）。

Inclusion criteria

1. Age >=18 years old; 2. Patients with histologically or cytologically confirmed, locally advanced (stage IIIB/IIIC), metastatic or recurrent (stage IV) squamous NSCLC according to the International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer 8th Edition TNM classification of lung cancer, who are inoperable and not amenable to definitive concurrent chemoradiotherapy; 3. At least one radiographic measurable lesion according to response evaluation Criteria in Solid Tumors (RECIST, version 1.1); 4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1; 5. Had not received any previous systemic antitumor therapy for advanced/metastatic disease. Patients who had received previous platinum-based adjuvant or neoadjuvant chemotherapy or definitive chemoradiotherapy for advanced disease were allowed if they had disease progression or relapse at least 6 months after the last dose of chemotherapy. 6. Expected survival time >3 months; 7. Adequate organ and bone marrow function and laboratory values within the 7 days before enrollment (no administration of blood components, cell growth factors, albumin, or other corrective medications during the 14 days before laboratory testing was obtained) were required, as follows: 1) Complete blood count: absolute neutrophil count (ANC) >=1.5×109/L, platelet (PLT) >=75×109/L, hemoglobin (HGB) >=90 g/L (no blood transfusion or erythropoietin dependence within 14 days) 2) Liver function: serum total bilirubin (TBIL) <=2 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) <=5 times ULN, serum albumin >=28 g/L; alkaline phosphatase (ALP<=5×ULN). 3) Renal function: serum creatinine (Cr) <=1.5×ULN, or creatinine clearance >=50 mL/min (using the standard Cockcroft-Gault formula) : urine routine results showed urine protein < 2+; Patients with a urine protein level of 2+ or more on routine urinalysis at baseline should undergo a 24-hour urine collection with a 24-hour urinary protein quantification of less than 1g. 4) Coagulation function: INR or PT <=1.5 times ULN; If the subject was receiving anticoagulant therapy, the INR was within the intended range for anticoagulant therapy. 8. For women of childbearing age, a negative urine or serum pregnancy test should be performed 3 days prior to receiving the first dose of study drug; 9. Participants and their sexual partners are required to use a medically approved contraceptive method (e.g. intrauterine device, contraceptive pill or condom) during the study treatment period and for 6 months after the end of the study treatment period.

排除标准：

1.组织学为非鳞状细胞NSCLC； 2.已知EGFR敏感突变或ALK重排的患者； 3.影像学（CT或者MRI）显示肿瘤侵犯大血管者或经判断后续研究期间肿瘤极有可能侵袭重要血管引起致命大出血者； 4.当前正在参与干预性临床研究治疗，或在首次给药前4周内接受过其他研究药物或研究器械治疗； 5.既往接受过下列疗法：抗PD-1、抗PD-L1或抗PD-L2药物或者针对另一种刺激或协同抑制T细胞受体（例如，CTLA-4、OX-40、CD137）的药物； 6.首次给药前2周内接受过具有抗肿瘤适应症的中成药或免疫调节作用的药物（胸腺肽、干扰素、白介素等），或首次给药前3周内接受过重大手术治疗； 7.存在需临床干预的活动性咯血、活动性憩室炎、腹腔脓肿、胃肠道梗阻和腹膜转移； 8.III-IV级充血性心力衰竭（纽约心脏病协会分级），控制不佳且有临床意义的心律失常； 9.在入选治疗前6个月内发生过任何动脉血栓、栓塞或缺血，如心肌梗死、不稳定型心绞痛、脑血管意外或一过性脑缺血发作等； 10.已知对PD-1/L1单抗、紫杉醇类药物、顺铂或卡铂、重组人血管内皮抑制素、曲拉西利活性成分和或任何辅料有过敏反应； 11.需要长期全身性使用皮质类固醇的患者。由于COPD、哮喘需要间断使用支气管扩张药、吸入性皮质类固醇，或局部注射皮质类固醇的患者可以入组； 12.存在脑膜转移，以及其他有症状的中枢神经转移； 13.有需要治疗的活动性感染或首次给药前一周内使用过全身性抗感染药物； 14.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）； 15.已知人类免疫缺陷病毒（HIV）感染史（即HIV 1/2抗体阳性）； 16.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化疗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 17.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）； 18.首次给药之前（第1周期，第1天）30天内接种过活疫苗； 19.妊娠或哺乳期妇女； 20.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：

1. Histologically non-squamous cell NSCLC; 2. Patients with known EGFR sensitive mutations or ALK rearrangements; 2. 3. If the tumor had invaded large blood vessels by imaging (CT or MRI) or it was judged that the tumor was likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study; 4. Currently participating in an interventional clinical study treatment, or receiving another study drug or study device within 4 weeks before the first dose; 5. Previous therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent targeting another T-cell receptor that stimulates or coinhibits it (e.g., CTLA-4, OX-40, CD137); 6. Received Chinese patent medicine or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) with anti-tumor indications within 2 weeks before the first dose, or received major surgical treatment within 3 weeks before the first dose; 7. Presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction, and peritoneal metastasis requiring clinical intervention; 8. Grade III-IV congestive heart failure (New York Heart Association class) with poorly controlled clinically significant arrhythmias; 9. Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, occurred within 6 months before enrollment; 10. Known allergic reactions to PD-1/L1 monoclonal antibodies, taxanes, cisplatin or carboplatin, recombinant human endostatin, the active ingredient of treaclib, and or any excipients; 11. Patients requiring long-term systemic corticosteroids. Patients who required intermittent use of bronchodilators, inhaled corticosteroids, or topical corticosteroid injections due to COPD or asthma were eligible. 12. Presence of leptomeningeal metastases and other symptomatic central nervous system metastases; 13. Active infection requiring treatment or use of systemic anti-infective drugs within one week before the first dose; 14. Has not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., grade ≤1 or at baseline, excluding fatigue or alopecia); 15. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 16. Untreated active hepatitis B (defined as both HBsAg positivity and HBV-DNA copies greater than the upper limit of normal range in the laboratory of 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 chemotherapy 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 viral reactivation should be closely monitored 17. Active HCV-infected subjects (HCV-antibody positive and HCV-RNA level above the lower limit of detection); 18. Received a live vaccine within 30 days before the first dose (cycle 1, day 1); 19. Pregnant or lactating women; 20. Medical history or evidence of disease, abnormal treatment or laboratory test values that may interfere with the results of the trial, prevent the subjects from participating in the study fully, or other conditions considered by the investigator to be unsuitable for enrollment.

研究实施时间：

Study execute time：

从 From 2024-12-31 00:00:00至 To 2027-09-30 00:00:00

征募观察对象时间：

Recruiting time：

从From 2024-12-31 00:00:00 至 To 2026-03-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	40
Group：	Experimental group	Sample size：	40
干预措施：	重组人血管内皮抑制素+注射用盐酸曲拉西利+免疫治疗+含铂化疗	干预措施代码：
Intervention：	Recombinant human endostatin+trilaciclib+immunotherapy+platinum based chemotherapy	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

国家：	中国	省(直辖市)：	江西	市(区县)：
Country：	China	Province：	Jiangxi	City：
单位(医院)：	南昌大学第一附属医院	单位级别：	三甲
Institution hospital：	The first affiliated hostipal of nanchang university	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	湖北	市(区县)：
Country：	China	Province：	Hubei	City：
单位(医院)：	华中科技大学同济医学院附属协和医院	单位级别：	三甲
Institution hospital：	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	12个月无进展生存期	指标类型：	主要指标
Outcome：	12month-PFS	Type：	Primary indicator
测量时间点：	首次用药后12个月	测量方法：	事件定义为自随机至首次影像学疾病进展或死亡（以先发生者为准）
Measure time point of outcome：	12 months after the first medication	Measure method：	The event is defined as the progression or death of the disease from randomization to the first imaging (whichever occurs first)

指标中文名：	客观缓解率	指标类型：	主要指标
Outcome：	ORR	Type：	Primary indicator
测量时间点：	治疗阶段每6周（2个周期，42天）评估一次；维持治疗阶段每隔9周评估一次	测量方法：	根据RECIST1.1进行肿瘤影像学疗效评价。评估结果分为完全缓解（CR）、部分缓解（PR）、疾病稳定（SD）、疾病进展（PD）和不可评价（NE）。客观缓解率（ORR），定义为完全缓解（CR）及部分缓解（PR）的受试者占分析人群的比例。
Measure time point of outcome：	Every 6 weeks during the treatment phase; every 9 weeks during the maintenance treatment phase	Measure method：	Evaluate the therapeutic effect of tumor imaging according to RECIST 1.1. The evaluation results are divided into complete remission (CR), partial remission (PR), disease stability (SD), disease progression (PD), and non evaluable (NE). Objective response rate (ORR) is defined as the proportion of subjects who achieved complete response (CR) and partial response (PR) in the analyzed population.

指标中文名：	疾病控制率	指标类型：	次要指标
Outcome：	DCR	Type：	Secondary indicator
测量时间点：	治疗阶段每6周（2个周期，42天）评估一次；维持治疗阶段每隔9周评估一次	测量方法：	根据RECIST1.1进行肿瘤影像学疗效评价。评估结果分为完全缓解（CR）、部分缓解（PR）、疾病稳定（SD）、疾病进展（PD）和不可评价（NE）。疾病控制率（DCR），定义为完全缓解（CR）、部分缓解（PR）及疾病稳定（SD）的受试者占分析人群的比例。
Measure time point of outcome：	Every 6 weeks during the treatment phase; every 9 weeks during the maintenance treatment phase	Measure method：	Evaluate the therapeutic effect of tumor imaging according to RECIST 1.1. The evaluation results are divided into complete remission (CR), partial remission (PR), disease stability (SD), disease progression (PD), and non evaluable (NE). Disease control rate (DCR) is defined as the proportion of subjects in complete response (CR), partial response (PR), and disease stability (SD) in the analyzed population.

指标中文名：	缓解持续时间	指标类型：	次要指标
Outcome：	DOR	Type：	Secondary indicator
测量时间点：	治疗阶段每6周（2个周期，42天）评估一次；维持治疗阶段每隔9周评估一次	测量方法：	疾病缓解时间（DoR），定义为是指肿瘤第一次评估为CR或PR开始到第一次评估为PD或任何原因死亡的时间。
Measure time point of outcome：	Every 6 weeks during the treatment phase; every 9 weeks during the maintenance treatment phase	Measure method：	Disease response time (DoR) is defined as the time from the first assessment of a tumor as CR or PR to the first assessment as PD or death from any cause.

指标中文名：	总生存期	指标类型：	次要指标
Outcome：	OS	Type：	Secondary indicator
测量时间点：	生存随访每90天一次	测量方法：	总生存期（OS），定义为自随机至受试者因任何原因死亡的时间。将在FAS及可评价分析集中进行分析。如患者直至研究结束或失访前均为发生死亡，将在最后一次随访日期删失。
Measure time point of outcome：	Survival follow-up every 90 days	Measure method：	Overall survival (OS) is defined as the time from randomization to the death of the subject for any reason. The analysis will be conducted in FAS and evaluable analysis sets. If the patient has died until the end of the study or before being lost to follow-up, they will be deleted on the last follow-up date.

指标中文名：	安全性	指标类型：	次要指标
Outcome：	Satety	Type：	Secondary indicator
测量时间点：	从给药开始后开始记录不良事件，直至安全性随访期结束	测量方法：	总结各治疗组中研究期间发生的不良事件并计算其发生率。不良事件的严重程度将基于 CTCAE5.0 版进行标准分级。所有不良事件还将用最新版本的 MedDRA 编码，按系统器官分类（SystemOrganClass）和标准名称（PreferredTerm）进行总结。不良事件的严重程度：同一受试者多次发生同一不良事件，以最严重的一次参与该 AE 的严重程度分析。
Measure time point of outcome：	Record adverse events from the start of administration until the end of the safety follow-up period	Measure method：	Summarize the adverse events that occurred during the study period in each treatment group and calculate their incidence rates. The severity of adverse events will be classified according to the CTCAE 5.0 version. All adverse events will also be summarized using the latest version of MedDRA coding, categorized by System Organ Class and Preferred Term. Severity of adverse events: The same subject experiences the same adverse event multiple times, and the severity of the AE is analyzed based on th

指标中文名：	骨髓保护作用	指标类型：	次要指标
Outcome：	myelosuppression benefits	Type：	Secondary indicator
测量时间点：	从给药开始后开始记录不良事件，直至安全性随访期结束	测量方法：	骨髓保护主要将根据CTCAE标准评价≥3级中性粒细胞减少发生率，将基于FAS集，进行计算，若一名受试者多次发生ANC<1.0×109/L，则仅将其计为1例事件。因此，联合治疗期内≥3级中性粒细胞减少的发生被定义为分类变量（是或否）。在计算≥3级中性粒细胞减少发生率时，分子为发生中性粒细胞绝对计数（ANC）<1.0×109/L的人数，分母为所纳入分析集的总人数。制表显示两组在治疗期间发生≥3级中性粒
Measure time point of outcome：	Record adverse events from the start of administration until the end of the safety follow-up period	Measure method：	Myelosuppression benefits will mainly evaluate the incidence of grade ≥ 3 neutropenia based on CTCAE standards, and will be calculated based on the FAS set. If a subject experiences ANC<1.0 × 109/L multiple times, it will only be counted as one event. Therefore, the occurrence of grade ≥ 3 neutropenia during the combination therapy period is defined as a categorical variable (yes or no).

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：
Sample Name：	None	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	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）：

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	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：	临床试验中的文件（方案和方案修订，完成的 eCRF，签署的 ICF 等）需按照 GCP 的要求进行保存和管理。研究中心应将这些文件保存到研究结束后 5 年。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Documents in clinical trials (protocols and protocol revisions, completed eCRF, signed ICF, etc.) must be stored and managed in accordance with the requirements of GCP. The research center should save these files for 5 years after the end of the study.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2024-12-30 16:12:55