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：	ChiCTR2500107128
最近更新日期： Date of Last Refreshed on：	2025-08-04 18:12:58
注册时间： Date of Registration：	2025-08-04 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	晚期肺鳞癌一线治疗免疫维持阶段联合盐酸二甲双胍缓释片/安慰剂的随机、对照、双盲、多中心临床研究
Public title：	Combination of metformin hydrochloride extended release tablets/placebo during the immunomaintenance phase of first-line treatment for advanced or metastatic lung squamous cell carcinoma, a randomized, controlled, double-blind, multicenter clinical trial
注册题目简写：	YZNE-01(NSCLC)
English Acronym：	YZNE-01(NSCLC)
研究课题的正式科学名称：	晚期肺鳞癌一线治疗免疫维持阶段联合盐酸二甲双胍缓释片/安慰剂的随机、对照、双盲、多中心临床研究
Scientific title：	Combination of metformin hydrochloride extended release tablets/placebo during the immunomaintenance phase of first-line treatment for advanced or metastatic lung squamous cell carcinoma, a randomized, controlled, double-blind, multicenter clinical trial
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：	彭文颖	研究负责人：	杨润祥
Applicant：	Wenying Peng	Study leader：	Runxiang Yang
申请注册联系人电话： Applicant telephone：	+86 188 7422 3568	研究负责人电话： Study leader's telephone：	+86 138 8887 6721
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：	pengwenying@kmmu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	yrx_research@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：	云南省昆明市西山区昆州路519号云南省肿瘤医院	研究负责人通讯地址：	云南省昆明市西山区昆州路519号云南省肿瘤医院
Applicant address：	Yunnan Cancer Hospital, 519 Kunzhou Road, Xishan District, Kunming, Yunnan	Study leader's address：	Yunnan Cancer Hospital, 519 Kunzhou Road, Xishan District, Kunming, Yunnan
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：	云南省肿瘤医院
Applicant's institution：	Yunnan Cancer Hospital
研究负责人所在单位：	云南省肿瘤医院
Affiliation of the Leader：	Yunnan Cancer 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：	YJZ2025-11	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：	云南省肿瘤医院伦理委员会
Name of the ethic committee：	Ethics Committee of Yunnan Cancer Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2025-07-21 00:00:00
伦理委员会联系人：	许玉玲
Contact Name of the ethic committee：	Yuling Xu
伦理委员会联系地址：	云南省昆明市昆州路519号云南省肿瘤医院伦理办公室
Contact Address of the ethic committee：	Ethics Office, Yunnan Cancer Hospital, 519 Kunzhou Road, Xishan District, Kunming, Yunnan
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 871 6817 9625	伦理委员会联系人邮箱： Contact email of the ethic committee：	ynzlyyll@163.com

研究实施负责（组长）单位：

云南省肿瘤医院

Primary sponsor：

Yunnan Cancer Hospital

研究实施负责（组长）单位地址：

云南省昆明市西山区昆州路519号云南省肿瘤医院

Primary sponsor's address：

Yunnan Cancer Hospital, 519 Kunzhou Road, Xishan District, Kunming, Yunnan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	云南省	市(区县)：	昆明市
Country：	China	Province：	Yunnan	City：	Kunming
单位(医院)：	云南省肿瘤医院	具体地址：	西山区昆州路519号
Institution hospital：	Yunnan Cancer Hospital	Address：	519 Kunzhou Road, Xishan District

经费或物资来源：

企业资助

Source(s) of funding：

Corporate sponsorship

研究疾病：

肺恶性肿瘤

Target disease：

Lung Neoplasm

研究疾病代码：

C34.900X001

Target disease code：

C34.900X001

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

上市后药物

Study phase：

4

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

本研究为研究者发起研究，拟前瞻性入组70例未经系统治疗的局部晚期或转移性鳞状非小细胞肺癌研究参与者，随机分为两组，研究过程中将进行1:1随机，免疫检查点抑制剂联合含铂双药化疗6周期后未进展者，试验组以免疫检查点抑制剂与盐酸二甲双胍缓释片维持治疗，对照组以免疫检查点抑制剂与安慰剂维持治疗，对比两组的有效性及安全性。主要研究终点：无进展生存时间（PFS）；次要研究终点：总生存（OS）、缓解持续时间（DoR）、治疗的安全性。

Objectives of Study：

This study is an investigator-initiated study that plans to prospectively enroll 70 participants with locally advanced or metastatic squamous non-small cell lung cancer who have not received systematic treatment and randomly divide them into two groups. During the study, a 1:1 randomization will be conducted for those who have not progressed after 6 cycles of immune checkpoint inhibitor combined with platinum-based dual-drug chemotherapy. The experimental group was maintained with immune checkpoint inhibitors and metformin hydrochloride extended release tablets, while the control group was maintained with immune checkpoint inhibitors and placebos. The efficacy and safety of the two groups were compared. Primary study endpoint: Progression-free survival time (PFS); Secondary study endpoints: Overall survival (OS), duration of response (DoR), and safety of treatment.

药物成份或治疗方案详述：

盐酸二甲双胍缓释片的主要药物成份是盐酸二甲双胍（Metformin Hydrochloride），化学名称为：1,1-二甲基双胍盐酸盐，辅料为羧甲纤维素纳、羟丙甲纤维素、硬脂酸铁。治疗方案：本实验为随机、对照、双盲、多中心临床研究，研究将受试者根据前期疗效分析结果适应性随机至两组，试验组为维持治疗阶段应用口服盐酸二甲双胍缓释片联合免疫检查点抑制剂，对照组为安慰剂联合免疫检查点抑制剂。盐酸二甲双胍缓释片/安慰剂为持续用药，C1d1 - d7 1片 po Qd； C1d8 - d14 2片 po Qd； C1d15 -d21 3片 po Qd； C2- Cn 3片 po Qd；免疫检查点抑制剂根据说明书用药，一般每21天用药一次。所用免疫检查点抑制剂为NCCN、ESMO、CSCO指南中推荐使用于晚期鳞状非小细胞肺癌的免疫检查点抑制剂，包括但不限于：信迪利单抗、替雷利珠单抗、阿替利珠单抗、斯鲁利单抗、卡瑞利珠单抗等

Description for medicine or protocol of treatment in detail：

The main drug component of metformin hydrochloride sustained-release tablets is metformin hydrochloride (Metformin Hydrochloride), with the chemical name: 1,1-dimethyl-2-imidazolidinone hydrochloride. The auxiliary ingredients are carboxymethyl cellulose, hydroxypropyl methylcellulose, and iron stearate. research approach: This study is a randomized, controlled, double-blind, multi-center clinical study. Participants will be randomly assigned to two groups based on the results of the preliminary efficacy analysis. The experimental group will use oral sustained-release metformin hydrochloride combined with immune checkpoint inhibitors during the maintenance treatment stage. The control group will use a placebo combined with immune checkpoint inhibitors. Metformin hydrochloride sustained-release tablets / placebo: continuous medication, C1d1 - d7 1 tablet po Qd; C1d8 - d14 2 tablets po Qd; C1d15 -d21 3 tablets po Qd; C2- Cn 3 tablets po Qd; Immunotherapy checkpoint inhibitors should be used according to the instructions, generally once every 21 days. The immunotherapy checkpoint inhibitors used are those recommended in the NCCN, ESMO, and CSCO guidelines for the treatment of advanced squamous non-small cell lung cancer, including but not limited to: sintilimab, tislelizumab, atezolizumab, sultilimab, camrelizumab, etc.

纳入标准：

1. 男性或女性，18岁（含）以上；
2. 患者体能状态评分（ECOG）在0-2分；
3. 预期生存期大于12周；
4. 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，既有组织学证实的不能手术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）鳞状非小细胞肺癌患者。（注意：混合肿瘤将按主要细胞类型进行分类，如果存在小细胞成分，则研究参与者不符合入组条件）
5. 组织学或细胞学确诊的晚期（IIIB-Ⅳ期）鳞状非小细胞肺癌后，经过一线免疫联合含铂双药化疗6周期，并且研究参与者在末次治疗后影像学（RECIST1.1标准）评估为疾病稳定（SD），部分缓解（PR），完全缓解（CR）。（所用免疫检查点抑制剂为NCCN、ESMO、CSCO指南中推荐使用于晚期鳞状非小细胞肺癌的免疫检查点抑制剂，包括但不限于：信迪利单抗、替雷利珠单抗、阿替利珠单抗、斯鲁利单抗、卡瑞利珠单抗等）。
6. 既往接受过辅助化疗的，疾病复发时间距末次辅助化疗时间的间隔应至少6个月；既往针对胸部的放疗结束时间距本次治疗的间隔时间应超过6个月。
7. 患者在RECIST1.1标准下至少有1个可评估的靶病灶（非颅内病灶），肿瘤评估完全缓解者除外；
8. 能够吞咽口服药物；
9. 血常规：中性粒细胞绝对计数（ANC）≥1.5×109/L或白细胞计数>3.5×109/L，血小板（PLT）≥80×109/L，血红蛋白（HGB）≥90 g/L；
10. 肝功能：血清总胆红素（TBIL）≤1.5 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）≤2.5倍ULN，血清白蛋白（ALB）≥2.8g/dL；
11. 肾功能：血清肌酐（Cr）≤1.5×ULN，或肌酐清除率≥40 mL/min（应用标准的 Cockcroft；-Gault 公式）：
女性： CrCl=[（140-岁数） × 体重（kg） × 0.85]/[72 × 血清肌酐（mg/dL）]
男性： CrCl=[（140-岁数）× 体重（kg）×1.00]/[72 × 血清肌酐（mg/dL）]
12. 研究参与者与研究参与者性伴侣需要在研究治疗期间和研究治疗期结束后 6 个月内采用至少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） ；
13. 研究参与者在进行本研究相关治疗时，充分理解、配合，并已取得研究参与者签名并注明日期的书面知情同意书;

Inclusion criteria

1. Male or female, above 18 years old (including).
2. The patient's ECOG score should be 0-2.
3. The expected survival time is greater than 12 weeks.
4. According to 8th edition of Lung Cancer TNM Staging System of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer, this study includes patients with locally advanced (stage IIIB/IIIC) or metastatic or recurrent (stage IV) squamous non-small cell lung cancer that has been confirmed by histology and for whom surgery is not feasible and who cannot undergo radical concurrent chemoradiotherapy. (Note: Mixed tumors will be classified according to the predominant cell type. If there is a small cell component, the study participants do not meet the inclusion criteria.)
5. After a histological or cytological diagnosis of advanced (IIIB-IV stage) squamous non-small cell lung cancer, the patients received 6 cycles of first-line immunotherapy combined with platinum-based double-drug chemotherapy. And the study participants were evaluated as stable disease (SD), partial response (PR), or complete response (CR) by radiological examination (according to the RECIST 1.1 standard) after the last cycle of chemotherapy. (The immune checkpoint inhibitors used were those recommended by the NCCN, ESMO, and CSCO guidelines for advanced squamous non-small cell lung cancer, including but not limited with: sintilimab, tislelizumab, atezolizumab, serplulimab, camrelizumab, etc.)
6. For those who have received adjuvant chemotherapy before, the interval between the recurrence of the disease and the last adjuvant chemotherapy should be at least 6 months; and the interval between the end of the previous thoracic radiotherapy and this treatment should be more than 6 months.
7. There is at least one evaluable lesion (non-intracranial lesion) under RECIST1.1 criteria
8.  Able to swallow pills
9.  blood routine examination: Absolute neutrophil count (ANC) >= 1.5×10^9/L or White blood cell count >3.5×10^9/L, platelet (PLT) >= 80×10^9/L, hemoglobin (HGB) >= 90 g/L.
10. Liver function: serum total bilirubin (TBIL) <= 1.5 times of the upper limit of normal (ULN), alanine aminotransferase (ALT) and/or Aspertate Aminotransferase (AST) <= 2.5 times ULN, serum albumin (ALB) >= 2.8g/dL.
11. Kidney function: serum creatinine (Cr) <= 1.5×ULN, or creatinine clearance rate>= 40 mL/min (standard Cockcroft
Gault formula) For females: CrCl=[(140-age) × weight (kg) × 0.85]/[72 × serum creatinine (mg/dL)] 
For males: CrCl=[(140-age) × weight (kg) ×1.00]/[72 × serum creatinine (mg/dL)]
12. The study participants and his/her couple are required to use at least one medical approved contraceptive measures (e.g. intrauterine device, contraceptive pill or condom) during the study treatment period and 6 months after the end of study treatment.
13. Before the treatment and sampling (peripheral blood and Defecate) analysis related to this study, The study participants can fully understand and cooperate, then an informed consent should be signed.

排除标准：

1. 组织学或细胞学病理证实存在小细胞成分，或主要成分为非鳞癌； 2. 有症状的中枢神经系统转移或脑膜转移，或转移不可控制，即放疗或其他局部治疗后 2 个月内经检查确认转移病变进展的或经研究者判断不适合入组的。 3. 患有 1 型或 2 型糖尿病的患者。 4. 手术和/或放疗治疗未能缓解的脊髓压迫，或既往诊断的脊髓压迫经治疗后没有临床证据显示在治疗期前疾病稳定≥1周； 5. 有临床症状的第三间隙积液需要反复引流（如少于4周1次），如经抽水或其他治疗仍无法控制的心包积液、胸腔积液和腹腔积液； 6. 首剂用药前≤5年并发其他恶性肿瘤，充分治疗的宫颈原位癌、基底细胞或鳞状上皮细胞皮肤癌、根治术后的局部前列腺癌、根治术后的导管原位癌除外（允许非转移性前列腺癌或乳腺癌的内分泌治疗）； 7. 活动性、已知或怀疑自身免疫性疾病（入选前可能存在的自身免疫疾病）包括但不仅限于重症肌无力、自身免疫性肝炎、系统性红斑狼疮、类风湿性关节炎、炎性肠病等。（1）仅需要激素替代疗法治疗的因自身免疫性甲状腺炎导致的残留甲状腺功能减退，或缺乏外因刺激的情况下预期不会复发的情况可以入组；（2）患有湿疹、牛皮癣、慢性单纯性苔藓或仅有白癜风皮肤病表现的患者（需排除银屑病性头节炎）如果皮疹覆盖面积小于体表面积10%，基线时疾病已充分控制且仅需要低效价的局部类固醇治疗，过去12个月内基础疾病未出现急性加重（不需要补骨脂素加紫外线辐射[PUVA]、甲氨蝶呤、类视黄醇、生物制剂、口服钙调磷脂酶抑制剂，高效价口服类固醇）则可以进入研究： 8. HBsAb阳性且HIV DNA拷贝数大于1000拷贝数/ml或200 IU/ml，或HCV阳性（HCV RNA或HCV Ab检测提示急慢性感染）或已知HIV阳性病史或已知的获得性免疫缺陷综合征 (Acquired Immumedeficiency Syndrome, AIDs)；HCV阳性（HCV RNA或HCV Ab检测提示急慢性感染）者控制后可入组。 9. 患有特发性肺纤维化病史、机化性肺炎（如阻塞性细支气管炎）、药物诱导的肺炎、需要类固醇治疗的放射性肺炎或有临床症状的活动性肺炎或其他严重影响肺功能的中重度肺部疾病（放射区存在放射性肺炎（纤维化）病史的患者可参加本研究）； 10. 活动性肺结核（tuberculosis,TB）或筛选前≤48周内有活动性肺结核感染病史的研究参与者，无论是否治疗； 11. 在开始研究药物治疗前7天内，具有需要静脉治疗的活动性病毒、细菌或全身性真菌感染的证据。需要任何全身性抗病毒药物、抗真菌药物或抗细菌药物治疗的活动性感染患者必须在开始研究药物治疗前至少一周完成治疗； 12. 在筛选期前28天内接受过大型手术，或计划在研究期间接受大型手术； 13. 筛选期前28天内使用减毒活疫苗，或预计研究期间需要使用此种减毒活疫苗，灭活CoVID-19疫苗可以入组。 14. 有严重的心血管疾病如心力衰竭、不稳定型心绞痛、不稳定性心律失常、未控制的高血压。 15. 既往接受过同种异体骨髓移植或实体器官移植的患者； 16. 已知有精神疾病、酗酒、无法戒烟、吸毒或药物滥用等情况； 17. 经研究者判断，研究参与者有其他可能导致本研究被迫中途终止的因素，如：不依从方案、其他的严重疾病（含精神疾病）需要合并治疗、有严重的实验室检查异常、伴有家庭或社会等因素、会影响到研究参与者的安全或资料及样品的收集。 18. 患者已签署其他临床试验知情同意书。

Exclusion criteria：

1. Histological or cytological pathology confirms the presence of small cell components, or the main component is non-squamous carcinoma. 2. Symptomatic central nervous system metastasis or meningeal metastasis, or metastasis that cannot be controlled, i.e., confirmed by examination within 2 months after radiotherapy or other local treatment, or judged by the investigator to be unsuitable for inclusion. 3. Patients with type 1 or type 2 diabetes. 4. Newly diagnosed or unrelieved spinal cord compression after treatment, or has been diagnosed before but no clinical evidence of disease stabilization >= 1 week before treatment. 5. Third space effusion with clinical symptoms needs repeated drainage (e.g., less than once every 4 weeks), such as pericardial effusion, pleural effusion, and peritoneal effusion that cannot be controlled by suction or other treatments. 6. Other malignant tumors diagnosed <= 5 years before the first dose, except for adequately treated carcinoma in situ of cervix, basal cell or squamous cell skin cancer, local prostate cancer after radical mastectomy, and ductal carcinoma in situ after radical mastectomy ( Endocrine therapy for non-metastatic prostate or breast cancer is allowed). 7. Active, known or suspected autoimmune diseases (autoimmune diseases that may exist before enrollment), including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease etc. (1) Residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy, or no replase expected in the absence of external stimulus are allowed (2) Patients with eczema, psoriasis, lichen simplex chronicus or only skin disease manifestations of vitiligo (psoriatic head arthritis needs to be excluded) if the rash covers area less than 10% of the body surface area, the disease has been adequately controlled at baseline and requires only low potency topical steroids with no acute exacerbations of underlying disease within past 12 months (no psoralen plus ultraviolet radiation [PUVA], methotrexate, retinoids, biologics, oral calcineurin inhibitors, high potency oral steroids) can enter the study. 8. Patients with a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obstructive bronchiolitis), drug-induced pneumonia, radiation-related pneumonitis requiring steroid therapy, or active pneumonia with clinical symptoms, or other moderate to severe lung disease seriously affect pulmonary function (patients with a history of radiation pneumonitis (fibrosis) limited in the radiation area can participate in this study). 8. HBsAb positive and HIV DNA copy number greater than 1000 copy number/ml or 200 IU/ml, or HCV positive (HCV RNA or HCV Ab detection indicates acute and chronic infection) or known HIV positive medical history or known Acquired Immunodeficiency Syndrome (Acquired Immunodeficiency Syndrome, AIDs), HCV positive (HCV RNA or HCV Ab detection indicates acute and chronic infection) can be enrolled after control. 9. Patients with a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obstructive bronchiolitis), drug-induced pneumonia, radiation-related pneumonitis requiring steroid therapy, or active pneumonia with clinical symptoms, or other moderate to severe lung disease seriously affect pulmonary function (patients with a history of radiation pneumonitis (fibrosis) limited in the radiation area can participate in this study). 10. The study participants with active tuberculosis (tuberculosis, TB) or a history of active tuberculosis infection within 48 weeks before screening, regardless of treatment or not. 11. Evidence of active viral, bacterial or systemic fungal infection requiring intravenous therapy within 7 days prior to initiation of study drug treatment. Patients with active infection requiring any systemic antiviral, antifungal, or antibacterial drug treatment must end at least one week before starting study drug treatment. 12. Received major surgery within 28 days before the screening period, or plan to undergo major surgery during the study period. 13. The attenuated live vaccine was used within 28 days before the screening period, or the live attenuated vaccine is expected to be used during the study period, while receiving inactivated CoVID-19 vaccine can be included in the group. 14. Diganosed with serious cardiovascular diseases such as heart failure, unstable angina, unstable arrhythmia, uncontrolled hypertension, myocardial infarction or cerebrovascular accident within 6 months before the screening period. 15. Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation. 16. Known mental illness, binge drinking, inability to quit smoking, take drugs or substance abuse. 17. According to the investigator's judgment, the subject has other factors that may cause the study to be terminated midway, such as: non-compliance with the protocol, other serious diseases (including mental diseases) requiring combined treatment, severe laboratory test abnormalities, accompanied by factors such as family or society, which will affect the safety of the subjects, or the collection of data and samples. 18. The patient has signed informed consent forms of other clinical trial.

研究实施时间：

Study execute time：

从 From 2025-08-05 00:00:00至 To 2027-08-05 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-08-05 00:00:00 至 To 2027-08-05 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	35
Group：	Experimental group	Sample size：	35
干预措施：	免疫检查点抑制剂维持阶段联合盐酸二甲双胍缓释片	干预措施代码：	experimental
Intervention：	Immune checkpoint inhibitor combined with metformin hydrochloride extended release tablets at maintenance phase	Intervention code：	experimental

组别：	对照组	样本量：	35
Group：	Control group	Sample size：	35
干预措施：	免疫检查点抑制剂维持阶段联合安慰剂	干预措施代码：	control
Intervention：	Immune checkpoint inhibitor combined with placebo at maintenance phase	Intervention code：	control

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	云南省	市(区县)：	昆明市
Country：	China	Province：	Yunnan	City：	Kunming
单位(医院)：	云南省肿瘤医院	单位级别：	三级
Institution hospital：	Yunnan Cancer Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	云南省	市(区县)：	曲靖市
Country：	China	Province：	Yunnan	City：	Qujing
单位(医院)：	曲靖市第一人民医院	单位级别：	三甲
Institution hospital：	Qujing First People’s Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	无进展生存期	指标类型：	主要指标
Outcome：	Progression-free survival	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	总生存时间	指标类型：	次要指标
Outcome：	Overall survival time	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：	safety	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：	无	组织：	无
Sample Name：	no	Tissue：	no
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）：

由随机人员采用区组随机方法随机生成区间长度为10的7组序列，第一名受试者入组时进行抽取随机序列1-7，前10名患者依据随机序列里面的数字依次对应至试验组或对照组，后续患者以此类推。

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

Seven groups of sequences with an interval length of 10 were randomly generated by random personnel using the block randomization method. When the first subject was enrolled, random sequences 1 to 7 were drawn. The first 10 patients were assigned to the experimental group or the control group in sequence according to the numbers in the random sequences, and so on for subsequent patients.

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：	受试者及研究者施盲
Blinding：	participants and researcher are blinded
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	NA
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	NA
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：	NA
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	NA
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：	2025-08-04 18:12:33