中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500099426
最近更新日期： Date of Last Refreshed on：	2025-03-24 11:59:40
注册时间： Date of Registration：	2025-03-24 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	信迪利单抗联合托莱西单抗治疗一线免疫治疗失败的晚期驱动基因阴性非小细胞项目名称肺癌患者的疗效和安全性的前瞻性、单臂Ⅱ期临床研究
Public title：	A Prospective, Single-Arm Phase II Clinical Study of the Efficacy and Safety of Sintilimab in Combination With Tolecimab in Patients With Advanced Driver Gene Negative Non-Small Cell Lung Cancer Who Have Failed First-Line Immunotherapy
注册题目简写：
English Acronym：
研究课题的正式科学名称：	信迪利单抗联合托莱西单抗治疗一线免疫治疗失败的晚期驱动基因阴性非小细胞项目名称肺癌患者的疗效和安全性的前瞻性、单臂Ⅱ期临床研究
Scientific title：	A Prospective, Single-Arm Phase II Clinical Study of the Efficacy and Safety of Sintilimab in Combination With Tolecimab in Patients With Advanced Driver Gene Negative Non-Small Cell Lung Cancer Who Have Failed First-Line Immunotherapy
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：	李子明	研究负责人：	李子明
Applicant：	Ziming Li	Study leader：	Ziming Li
申请注册联系人电话： Applicant telephone：	+86 21 62821990	研究负责人电话： Study leader's telephone：	+86 21 62821990
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：	liziming1980@163.com	研究负责人电子邮件： Study leader's E-mail：	liziming1980@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：	IS24209	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：	2025-01-02 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：

信达生物制药（苏州）有限公司

Source(s) of funding：

Innovent Biologics (Suzhou) Co., Ltd.

研究疾病：

肺癌

Target disease：

Lung cancer

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：

其它

Study phase：

N/A

研究设计：

单臂

Study design：

Single arm

研究目的：

在一线免疫或联合含铂化疗失败的晚期驱动基因阴性的PCSK9高表达非小细胞肺癌受试者中评估托莱西单抗联合信迪利单抗治疗的有效性和安全性研究。

Objectives of Study：

A Study to Evaluate the Efficacy and Safety of Tolelisib Combined with Sintilimab in Subjects with Advanced Driver Gene-Negative Non-Small Cell Lung Cancer Who Have High PCSK9 Expression and Have Failed First-Line Immunotherapy or Platinum-Based Chemotherapy.

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.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周岁且＜＝80周岁； 
3.组织学或细胞学证实局部晚期（IIIB-IIIC）、转移或复发性（IV期）NSCLC（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）； 
4.既往接受PD-(L)1抑制剂 (单独或与另一种全身性治疗联合)治疗后失败(CR、PR、SD＞6个月）； 
5.经组织学标本证实无EGFR基因敏感突变、ALK基因融合变异、ROS1基因突变、RET基因突变； 
6.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； 
7.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;
8.允许受试者接受姑息性放射治疗（包括针对症状性脑转移的颅脑放疗），但放疗需在入组前至少1周结束，并且放疗相关的毒性恢复至小于或等于1度（CTCAE 5.0，脱发除外）； 9.ECOG评分0-2分； 
10.预期生存时间>3个月； 
11.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）； 
12.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； 13.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

1. Signed written informed consent prior to the implementation of any trial-related procedures;
2. Age>=18 years old and <=80 years old;
3. Histologically or cytologically confirmed locally advanced (IIIB-IIIC), metastatic or recurrent (stage IV) NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Cancer Classification 9th edition TNM lung cancer staging);
4. Failure of prior treatment with PD-(L)1 inhibitor (alone or in combination with another systemic therapy) (CR, PR, SD> 6 months);
5. No EGFR gene sensitivity mutations, ALK gene fusion mutations, ROS1 gene mutations, and RET gene mutations were confirmed by histological specimens;
6. At least one measurable lesion on imaging according to the efficacy evaluation criteria for solid tumors (RECIST v1.1). Lesions located in the field of prior radiotherapy can be considered measurable if progression is confirmed;
7. Subjects with brain metastases who are asymptomatic or symptomatic after local treatment are allowed to enroll, as long as the subjects meet the following conditions:
(1) Measurable lesions outside the central nervous system;
(2) No central nervous system symptoms or no aggravation of symptoms in at least 2 weeks;
(3) No glucocorticoid therapy is required, or glucocorticoid therapy is discontinued within 7 days before the first dose, or the glucocorticoid dosage is stable and reduced to less than 10mg/day prednisone (or equivalent dose) within 7 days before the first dose;
8. Subjects are allowed to receive palliative radiation therapy (including cranial radiation therapy for symptomatic brain metastases), provided that the radiotherapy is terminated at least 1 week prior to enrollment and that the radiotherapy-related toxicity recovers to less than or equal to 1 grade (CTCAE 5.0, except for alopecia); 9. ECOG score 0-2 points;
10. Expected survival time> 3 months;
11. Adequate organ function, subjects need to meet the following laboratory indicators: (1) In the case of no granulocyte colony-stimulating factor in the past 14 days, the absolute value of neutrophils (ANC) >=1.5x10^9/L; (2) In the case of no blood transfusion in the past 14 days, platelet >=100×10^9/L; (3) In the absence of blood transfusion or erythropoietin in the past 14 days, hemoglobin > 9g/dL; (4) total bilirubin <=1.5× upper limit of normal (ULN); (5) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in <=2.5× ULN (subjects with liver metastases are allowed ALT or AST <=5×ULN); (6) serum creatinine <=1.5×ULN and creatinine clearance (calculated using Cockcroft-Gault formula) >=60 ml/min; (7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) < = 1.5 times ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal limits. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) Cardiac enzyme spectrum within the normal range (if the investigator comprehensively judges that it is not clinically significant, simple laboratory abnormalities are also allowed to enroll);
12. For female subjects of childbearing age, a urine or serum pregnancy test with a negative result should be received within 3 days prior to receiving the first dose of study drug (Cycle 1 Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested. Females of non-childbearing potential are defined as at least 1 year postmenopausal, or have undergone surgical sterilization or hysterectomy; 13. If there is a risk of conception, all subjects, male or female, are required to use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of study drug).

排除标准：

1. 病理为小细胞肺癌（SCLC），包括 SCLC 与 NSCLC 混合的肺癌； 2. 患者接受过一线以上的 PD-(L)1 抑制剂单药或联合化疗治疗； 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. 已知对本研究药物信迪利单抗、托莱西单抗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. The pathology is small cell lung cancer (SCLC), including lung cancer with mixed SCLC and NSCLC; 2. Patients have received more than first-line PD-(L)1 inhibitor monotherapy or combination chemotherapy; 3. Have received the following treatments: (1) Received systemic anti-tumor therapy, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal medicine therapy with anti-tumor indications) within 3 weeks prior to treatment; (2) Treatment with any investigational drug within 4 weeks prior to treatment; (3) Receipt of high-dose immunosuppressive drugs (systemic glucocorticoids exceeding 10mg/day of prednisone or its equivalent) within 4 weeks prior to treatment; (4) Received a live attenuated vaccine within 4 weeks prior to treatment (or plans to receive a live attenuated vaccine during the study); (5) Major surgery (such as open, thoracotomy, or Kaifu surgery) within 4 weeks prior to treatment, or surgical wounds, ulcers, or fractures that have not healed. 4. Presence of clinically uncontrollable pleural effusion/ascites effusion (subjects who do not need to drain the effusion or who have stopped draining for 3 days without a significant increase in the effusion may be enrolled); 5. Subjects who have received chest radiation therapy greater than 30Gy within 6 months prior to treatment or palliative radiation therapy at doses of 30Gy and less within 7 days prior to treatment (palliative radiation therapy for bone lesions or intracranial lesions is allowed); 6. Active autoimmune disease requiring systemic therapy (e.g., use of disease-modifying medications, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or for the adrenal or pituital glands.) physiologic glucocorticoids for insufficiency) are not considered systemic therapy; 7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Those who are known to be allergic to the active ingredients or excipients of sintilimab and tolecimab of this investigational drug; 9. Have not recovered adequately from toxicity and/or complications induced by any of the interventions (i.e., ≤ Grade 1 or to baseline, excluding fatigue or alopecia, prior to initiation of treatment); 10. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 11. Untreated active hepatitis B (defined as HBsAg positivity and detection of HBV-DNA copy number greater than the upper limit of normal in the laboratory department of the study center); Note: Subjects with hepatitis B who meet the following criteria may also be enrolled: (1) HBV viral load < 1000 copies/ml (200 IU/ml) prior to the first dose, and subjects should receive anti-HBV therapy throughout the study drug treatment period to avoid viral reactivation; (2) prophylactic anti-HBV therapy is not required for subjects with anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV viral load(-), but requires close monitoring for viral reactivation; 12. Subjects with active HCV infection (HCV antibody positive and HCV-RNA levels above the lower limit of detection); 13. Vaccination with a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1); Note: Injectable inactivated virus vaccine against seasonal influenza within 30 days prior to the first dose is permitted; However, intranasal live attenuated influenza vaccine is not permitted. 14. Pregnant or lactating women; 15. Presence of any serious or uncontrolled systemic disease, such as: (1) Resting ECG has major abnormalities in rhythm, conduction or morphology and the symptoms are severe and difficult to control, such as complete left bundle branch block, heart block above the second degree, ventricular arrhythmia or atrial fibrillation; (2) unstable angina, congestive heart failure, New York Heart Association (NYHA) classification >= 2 chronic heart failure; (3) Myocardial infarction within 6 months prior to enrollment; (4) Poor blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); (5) History of non-infectious pneumonitis requiring glucocorticoid therapy within 1 year prior to the first dose, or current presence of clinically active interstitial lung disease; (6) Active tuberculosis; (7) Presence of active or uncontrolled infection requiring systemic therapy; (8) Presence of clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction; (9) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; (10) Poorly controlled diabetes mellitus (fasting blood glucose (FBG) >10mmol/L); (11) Those whose urine routine showed that urine protein was >=++, and confirmed that the 24-hour urine protein quantification > 1.0 g; (12) Subjects with mental disorders who are unable to cooperate with treatment; 16. Medical history or evidence of disease, treatment, or laboratory tests that may interfere with the results of the trial and prevent the subject from participating in the study throughout the study abnormal, or other conditions that are considered by the investigator to be unsuitable for enrollment and other potential risks that the investigator considers to be unsuitable for participation in this study.

研究实施时间：

Study execute time：

从 From 2025-03-15 00:00:00至 To 2027-03-15 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-03-24 00:00:00 至 To 2026-03-15 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	53
Group：	Experimental group	Sample size：	53
干预措施：	1.托莱西单抗，300mg，每周期第 1 天腹部皮下注射，每 3 周为 1 周期（Q3W）。 2.信迪利单抗，200mg，每周期第 1 天静脉输注给药，每 3 周为 1 周期（Q3W）。信迪利单抗和托莱西单抗持续用药，直至疾病进展、死亡、毒性不可耐受、撤回知情同意、开始新的抗肿瘤治疗或方案规定的其他原因终止治疗，最长使用时间为 2 年。	干预措施代码：
Intervention：	1. Tolecimab, 300mg, administered subcutaneously into the abdomen on Day 1 of each cycle, for 1 cycle every 3 weeks (Q3W). 2. Sintilimab, 200mg, administered by intravenous infusion on Day 1 of each cycle, for 1 cycle every 3 weeks (Q3W). Sintilimab and tolecimab are continued until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new antineoplastic therapy, or discontinuation of treatment for other reasons specified in the protocol, up to a maximum of 2 years.	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：	三级甲等
Institution hospital：	Shanghai Chest?Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	总生存时间（OS）	指标类型：	次要指标
Outcome：	Overall survival	Type：	Secondary indicator
测量时间点：	每6周±7天一次	测量方法：	治疗过程中采用RECIST v1.1进行临床肿瘤影像学评价，每6周一次评估；用药24周后，可每9周一次评估。
Measure time point of outcome：	Every 6 weeks ± 7 days	Measure method：	During the treatment process, RECIST v1.1 is used for clinical tumor imaging evaluation, with assessments conducted every 6 weeks; after 24 weeks of medication, assessments can be conducted every 9 weeks.

指标中文名：	肿瘤客观缓解率(ORR)	指标类型：	次要指标
Outcome：	Objective Response Rate	Type：	Secondary indicator
测量时间点：	每6周±7天一次	测量方法：	通过实体瘤疗效评价系统RECIST v1.1的标准
Measure time point of outcome：	Every 6 weeks ± 7 days	Measure method：	Use RECIST 1.1 criteria

指标中文名：	无进展生存期(PFS)	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：	通过实体瘤疗效评价系统RECIST v1.1的标准
Measure time point of outcome：	Every 6 weeks ± 7 days	Measure method：	Use RECIST 1.1 criteria

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	80	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	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：	CRF表
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CRF
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2025-03-24 11:59:26