ChiCTR2500103223 版本V1.1 版本创建时间2025/06/05 14:53:39 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：

 ChiCTR2500103223 

最近更新日期：

Date of Last Refreshed on：

 2025-05-27 09:31:40 

注册时间：

Date of Registration：

 2025-05-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

阿得贝利单抗联合化疗治疗局限期复发SCLC的单臂探索性研究

Public title：

A Single-Arm Exploratory Study of Adebrelimab Combined with Chemotherapy in the Treatment of Locally Recurrent Small Cell Lung Cancer (SCLC)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

阿得贝利单抗联合化疗治疗局限期复发SCLC的单臂探索性研究

Scientific title：

A Single-Arm Exploratory Study of Adebrelimab Combined with Chemotherapy in the Treatment of Locally Recurrent Small Cell Lung Cancer (SCLC)

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：

孟祥姣 

研究负责人：

孟祥姣 

Applicant：

Meng Xiangjiao 

Study leader：

Meng Xiangjiao 

申请注册联系人电话：

Applicant telephone：

 +86 137 9315 0996

研究负责人电话：

Study leader's
telephone：

+86 137 9315 0996

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：

 mengxiangjiao@126.com

研究负责人电子邮件：

Study leader's E-mail：

 mengxiangjiao@126.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：

山东省济南市槐荫区济充路440号

研究负责人通讯地址：

山东省济南市槐荫区济充路440号

Applicant address：

No. 440, Jichong Road, Huaiyin District, Jinan City, Shandong Province

Study leader's address：

No. 440, Jichong Road, Huaiyin District, Jinan City, Shandong 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：

山东第一医科大学附属肿瘤医院(山东省肿瘤医院)

Applicant's institution：

Cancer Hospital Affiliated to Shandong First Medical University (Shandong Cancer Hospital)

研究负责人所在单位：

山东第一医科大学附属肿瘤医院(山东省肿瘤医院)

Affiliation of the Leader：

Cancer Hospital Affiliated to Shandong First Medical University (Shandong 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：

 SDZLEC2025-070-02

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：

山东第一医科大学附属肿瘤医院伦理委员会

Name of the ethic committee：

Ethics Committee of the Affiliated Cancer Hospital of Shandong First Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-03-12 00:00:00

伦理委员会联系人：

宋现让

Contact Name of the ethic committee：

Xianrang Song

伦理委员会联系地址：

山东省济南市槐荫区济兖路440号山东省肿瘤医院

Contact Address of the ethic committee：

Shandong Cancer Hospital, No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 183 5336 9763

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：

山东第一医科大学附属肿瘤医院（单中心）

Primary sponsor：

Cancer Hospital Affiliated of Shandong First Medical University

研究实施负责（组长）单位地址：

山东省济南市槐荫区济兖路440号

Primary sponsor's address：

Adebrelimab (1200 mg) is provided for free and supplied by Hengrui Medicine Co., Ltd.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

山东

市(区县)：

济南

Country：

China

Province：

Shandong

City：

Jinan

单位(医院)：

山东第一医科大学附属肿瘤医院

具体地址：

山东省济南市槐荫区济兖路440号

Institution
hospital：

Cancer Hospital Affiliated of Shandong First Medical University

Address：

No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province, China

经费或物资来源：

阿得贝利单抗（1200 mg，9500元/瓶）全免，由恒瑞医药公司提供

Source(s) of funding：

Adebrelimab (1200 mg) is provided for free and supplied by Hengrui Medicine Co., Ltd.

研究疾病：

小细胞肺癌  

Target disease：

SCLC

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

单臂 

Study design：

Single arm 

研究目的：

评价阿得贝利单抗联合化疗治疗局限期复发的小细胞肺癌（limited-stage small cell lung cancer, LS-SCLC）的6个月无进展生存率；  

Objectives of Study：

To evaluate the 6-month progression-free survival rate of Aderlimab combined with chemotherapy in the treatment of locally recurrent limited-stage small cell lung cancer (LS-SCLC)

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

受试者必须符合以下所有入组标准，才具有进入本研究的资格： 1. 年龄18岁以上，男女均可； 2. 经组织学证实的小细胞肺癌； 3. ECOG体能状况评分0~1分； 4. 初诊时为局限期且在同步/序贯放化疗结束后＞＝6个月发生疾病进展（局限期根据美国癌症联合委员会第8版定义为I-III期，所有病灶能包含在一个可耐受的放射治疗计划中）； 5. 局限期时接受过PD-(L)1抑制剂治疗； 6. 存在至少一个RECIST标准v1.1定义的可测量病灶； 7. 肺功能：检查1秒用力呼气量（FEV1）＞70%的预测值； 8. 实验室检查值满足以下条件按下述实验室检查结果定义，有足够的血液学和终末器官功能，这些检查结果需在首次研究治疗前7天内完成： （1） 血常规：绝对中性粒细胞计数（ANC）＞＝1.5×10^9/L，且在首次研究治疗前14天内未接受粒细胞集落刺激因子支持治疗；血小板计数（PLT）＞＝100×10^9/L，血红蛋白（Hb）＞＝ 90g/L，且在首次研究治疗前14天内未输血； （2） 肝功能：天门冬氨酸氨基转移酶（aspartate transferase, AST）以及丙氨酸肝氨基转移酶（alanine aminotransferase, ALT）＜＝3 x ULN；血清总胆红素（total bilirubin, TBIL）＜＝1.5 x ULN (确诊Gilbert 综合征患者，总胆红素＜＝3.0 mg/dL) ；白蛋白（albumin, ALB）＞＝3 g/dL； （3） 肾功能：血清肌酐＜＝1.5 x ULN 或 肌酐清除率 (creatinine clearance rate, CrCl) ＞＝50 mL/minute (可采用Cockcroft-Gault公式，慢性肾脏病流行病学合作研究公式,或肾脏病饮食改良公式计算肌酐清除率)。尿蛋白＜2+（如果尿蛋白＞＝2+，需额外检测24小时尿蛋白定量，24小时尿蛋白定量＜1g的受试者可以入组研究）； （4） 凝血功能：国际标准化比率（international normalized ratio, INR）＜＝1.5，活化部分凝血活酶时间（activated partial thromboplastin time, APTT）＜＝1.5 x ULN； （5） 心脏彩超检查：左室射血分数（LVEF）＞＝50%； 9. 非手术绝育的育龄期女性或男性受试者，需同意在研究治疗期间和研究治疗期结束后3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）进行避孕；非手术绝育的育龄期女性受试者在首次给药前的7天内血清HCG检查必须为阴性。 10. 受试者自愿加入本研究，签署知情同意书，依从性好，配合随访。

Inclusion criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment in this study: 1.Aged 18 years or older, both male and female are eligible. 2.Histologically confirmed small cell lung cancer. 3.ECOG performance status score of 0 to 1. 4.Initially diagnosed as limited-stage disease, and disease progression occurs>= 6 months after the completion of concurrent/sequential chemoradiotherapy (limited-stage is defined as stage I-III according to the 8th edition of the American Joint Committee on Cancer, and all lesions can be included in a tolerable radiotherapy plan). 5.Have received PD-(L)1 inhibitor treatment during the limited-stage period. 6.Have at least one measurable lesion as defined by RECIST criteria v1.1. 7.Pulmonary function: Forced expiratory volume in one second (FEV1) > 70% of the predicted value upon examination. 8.Laboratory test values meet the following conditions. According to the definitions of the following laboratory test results, there should be sufficient hematological and end-organ functions, and these test results should be completed within 7 days before the first study treatment: (1) Blood routine: Absolute neutrophil count (ANC) >= 1.5×10?/L, and no granulocyte colony-stimulating factor support treatment within 14 days before the first study treatment; Platelet count (PLT) >= 100×10?/L, Hemoglobin (Hb) >= 90g/L, and no blood transfusion within 14 days before the first study treatment. (2) Liver function: Aspartate transferase (AST) and alanine aminotransferase (ALT) 3 x ULN; Serum total bilirubin (TBIL) 1.5 x ULN (for patients diagnosed with Gilbert syndrome, total bilirubin <= 3.0 mg/dL); Albumin (ALB) >= 3 g/dL. (3) Renal function: Serum creatinine <=1.5 x ULN or Creatinine clearance rate (CrCl) >=50 mL/minute (The Cockcroft-Gault formula, the Chronic Kidney Disease Epidemiology Collaboration formula, or the Modification of Diet in Renal Disease formula can be used to calculate the creatinine clearance rate). Urine protein < 2+ (If urine protein >= 2+, an additional 24-hour urine protein quantification test is required, and subjects with a 24-hour urine protein quantification < 1g can be enrolled in the study). (4) Coagulation function: International normalized ratio (INR) <= 1.5, Activated partial thromboplastin time (APTT) <= 1.5 x ULN. (5) Echocardiogram examination: Left ventricular ejection fraction (LVEF) >= 50%. 9.For female and male subjects of childbearing potential who have not undergone surgical sterilization, they are required to agree to use at least one medically approved contraceptive measure (such as an intrauterine device, contraceptive pills, or condoms) for contraception during the study treatment period and within 3 months after the end of the study treatment period; Female subjects of childbearing potential who have not undergone surgical sterilization must have a negative serum HCG test result within 7 days before the first administration. 10.The subject voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with the follow-up.

排除标准：

1.组织学确认的混合型SCLC或NSCLC； 2.初诊为广泛期SCLC； 3.可手术的SCLC（临床分期T1-2N0如果有手术禁忌或拒绝手术者除外）； 4.已知或可疑有间质性肺炎的受试者；其他可能会干扰药物相关肺毒性的检测或处理的、严重影响呼吸功能的中重度肺部疾病。包括例如特发性肺组织纤维化、机化性肺炎/闭塞性细支气管炎等； 5.活动性、已知或怀疑自身免疫性疾病及自身免疫性疾病病史，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。允许I型糖尿病（通过胰岛素治疗血糖得以控制）、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；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（需排除银屑病性关节炎）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]、氨甲喋呤、类视黄醇、生物制剂、口服钙调磷酸酶抑制剂、高效价或口服类固醇）则可以进入研究； 6.首剂用药前<= 5年并发其他恶性肿瘤，除外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（允许非转移性前列腺癌或乳腺癌的激素治疗）； 7.显著临床意义的心血管疾病史者，包括但不局限于；(1) 充血性心衰（NYHA 分级＞2级）；(2) 不稳定性心绞痛；(3) 签署ICF前3个月内发生过心肌梗塞； (4) 任何需要治疗或者干预的室上性心律失常或室性心律失常； 8.首次用药前4周内存在重度感染，包括但不限于需住院治疗的菌血症、重症肺炎等；首次用药前2周内存在需使用系统抗生素治疗的CTCAE>=2级的活动性感染； 9.通过病史或CT检查发现入组前1年内有活动性肺结核感染者，或超过1年以前有活动性肺结核感染病史但未经正规治疗者； 10.有免疫缺陷病史，包括HIV血清检测阳性； 11.活动性乙肝或丙肝患者。HBsAg或HBcAb阳性患者如果HBV DNA检测小于所在研究中心检测正常值上限可参与本研究。HCV抗体阳性患者如果HCV RNA检测小于所在研究中心检测正常值上限（若该中心无正常值上限，则HBV-DNA必须＜ 500 IU/ml）可参与本研究； 12.首次研究用药前14天内接受过系统性免疫抑制剂治疗（包括但不局限于糖皮质激素、环磷酰胺、硫唑嘌呤、甲氨蝶呤、沙利度胺和抗肿瘤坏死因子[抗-TNF]药物等）者； - 对于接受短期、全身性免疫抑制剂治疗的患者（例如因恶心、呕吐、或过敏反应管理或预防用药给予糖皮质激素），经研究者与资助方协商，并经资助方批准后，可能会参与本项研究。在这些患者中，还将与资助方确定在随机化之前是否需要一个洗脱期以及洗脱期的持续时间； - 允许使用吸入式糖皮质激素治疗慢性阻塞性肺疾病的患者、盐皮质激素类（如氟氢可的松）治疗体位性低血压者，和使用低剂量糖皮质激素（ <=10 mg/天的泼尼松或等价激素）补充剂治疗肾上腺皮质功能不全； 13.首次用药前28天内接受过大型手术（以诊断为目的的手术除外），或预期将在研究期间接受大型手术（以诊断为目的的手术除外）；首次用药前7天内接受过诊断性或低创伤性手术； 14.首次用药前28天内使用减毒活疫苗，或预计研究期间需要使用减毒活疫苗（首次用药前28天内、治疗期间以及阿得贝利单抗末次给药后5个月内患者不允许接种流感减毒活疫苗）； 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.已知对单克隆抗体/融合蛋白类药物有严重过敏反应病史； 17.已知有精神疾病、酗酒、吸毒或药物滥用等情况； 18.经研究者判断，受试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，会影响到受试者的安全，或资料及样品的收集。

Exclusion criteria：

1.Histologically confirmed mixed small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC). Initially diagnosed as extensive-stage SCLC. 2.Operable SCLC (Clinical stage T1-2N0, except for those with surgical contraindications or who refuse surgery). 3.Subjects with known or suspected interstitial pneumonia; Other moderate to severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity and severely affect respiratory function. This includes, for example, idiopathic pulmonary fibrosis, organizing pneumonia/bronchiolitis obliterans, etc. 4.Active, known or suspected autoimmune diseases and a history of autoimmune diseases, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc. Subjects with type 1 diabetes mellitus (with blood glucose controlled by insulin treatment), residual hypothyroidism due to autoimmune thyroiditis that only requires hormone replacement therapy, or conditions that are not expected to recur without external stimulation are allowed to be enrolled; Patients with eczema, psoriasis, lichen simplex chronicus, or only skin manifestations of vitiligo (psoriatic arthritis needs to be excluded) can enter the study if the rash covers an area of less than 10% of the body surface area, the disease is well-controlled at baseline and only requires low-potency topical steroid treatment, and the underlying disease has not had an acute exacerbation in the past 12 months (no need for psoralen plus ultraviolet radiation [PUVA], methotrexate, retinoids, biologics, oral calcineurin inhibitors, high-potency or oral steroids). Concurrent with other malignant tumors <= 5 years before the first dose of the drug, except for fully treated cervical in-situ carcinoma, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, ductal in-situ carcinoma after radical surgery (hormone therapy for non-metastatic prostate cancer or breast cancer is allowed). 5.History of cardiovascular diseases with significant clinical significance, including but not limited to: (1) Congestive heart failure (NYHA class > 2); (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 3 months before signing the Informed Consent Form (ICF); (4) Any supraventricular or ventricular arrhythmia that requires treatment or intervention. 6.Severe infection within 4 weeks before the first dose of the drug, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc.; Active infection with CTCAE grade >= 2 that requires systemic antibiotic treatment within 2 weeks before the first dose of the drug. 7.Active pulmonary tuberculosis infection found by medical history or CT examination within 1 year before enrollment, or a history of active pulmonary tuberculosis infection more than 1 year ago but without regular treatment. 8.History of immunodeficiency, including positive HIV serological test results. 9.Patients with active hepatitis B or hepatitis C. Patients who are positive for HBsAg or HBcAb can participate in this study if the HBV DNA test result is less than the upper limit of the normal value detected by the study center. Patients who are positive for HCV antibody can participate in this study if the HCV RNA test result is less than the upper limit of the normal value detected by the study center (if there is no upper limit of the normal value in the center, then HBV-DNA must be < 500 IU/ml). 10.Subjects who have received systemic immunosuppressive treatment within 14 days before the first study drug administration (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] drugs, etc.). 11.For patients who have received short-term, systemic immunosuppressive treatment (for example, glucocorticoids given for the management or prevention of nausea, vomiting, or allergic reactions), after consultation between the investigator and the sponsor and with the approval of the sponsor, they may participate in this study. In these patients, it will also be determined together with the sponsor whether a washout period is required before randomization and the duration of the washout period. 12.Patients treated with inhaled glucocorticoids for chronic obstructive pulmonary disease, those treated with mineralocorticoids (such as fludrocortisone) for orthostatic hypotension, and those treated with low-dose glucocorticoid supplements (<=10 mg/day of prednisone or equivalent) for adrenal insufficiency are allowed. 13.Have received major surgery (excluding surgery for diagnostic purposes) within 28 days before the first dose of the drug, or are expected to receive major surgery (excluding surgery for diagnostic purposes) during the study period; Have received diagnostic or minimally invasive surgery within 7 days before the first dose of the drug. 14.Have used live attenuated vaccines within 28 days before the first dose of the drug, or are expected to need to use live attenuated vaccines during the study period (Patients are not allowed to receive live attenuated influenza vaccines within 28 days before the first dose of the drug, during the treatment period, and within 5 months after the last administration of Aderlimab). 15.Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation. 16.Known history of severe allergic reactions to monoclonal antibodies/fusion protein drugs. 17.Known history of mental illness, alcohol abuse, drug abuse, or substance abuse, etc. 18.As judged by the investigator, the subject has other factors that may lead to the forced termination of this study midway, such as non-compliance with the protocol, other serious diseases (including mental illness) that require combined treatment, serious laboratory test abnormalities, accompanied by family or social factors that will affect the safety of the subject, or the collection of data and samples.

研究实施时间：

Study execute time：

从 From 2024-12-01 00:00:00至 To 2027-12-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-01 00:00:00 至 To 2027-12-01 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 33

Group：

Intervention group

Sample size：

干预措施：

阿得贝利单抗 1200mg, IV, Q3W+卡铂AUC5或顺铂75mg/m2, D1，依托泊苷 100mg/m2 d1-3；21天为一个治疗周期；4-6个周期。

干预措施代码：

Intervention：

Adebrelimab 1200mg, administered intravenously (IV), every 3 weeks (Q3W) + Carboplatin at an area under the curve (AUC) of 5 or Cisplatin at a dose of 75mg/m2 on Day 1, and Etoposide at a dose of 100mg/m2 from Day 1 to Day 3; One treatment cycle is 21 days; A total of 4 to 6 cycles.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东省 

市(区县)：

  

Country：

China

Province：

Shandong

City：

单位(医院)：

 山东第一医科大学附属肿瘤医院(山东省肿瘤医院) 

单位级别：

 三级甲等 

Institution
hospital：

Cancer Hospital Affiliated of Shandong First Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 山东省 

市(区县)：

  

Country：

China

Province：

Shandong

City：

单位(医院)：

 山东省立医院 

单位级别：

 三级甲等 

Institution
hospital：

Cancer Hospital Affiliated of Shandong First Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

6个月无进展生存率

指标类型：

主要指标

Outcome：

The 6-month Progression-Free Survival (PFS) rate

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

客观缓解率

指标类型：

次要指标

Outcome：

Overall Response 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：

缓解持续时间

指标类型：

次要指标

Outcome：

Duration of Response

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疾病控制率

指标类型：

次要指标

Outcome：

Disease Control 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：

总生存期

指标类型：

次要指标

Outcome：

Overall Survival

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：

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：

标本中文名：

尿液

组织：

Sample Name：

Urine

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

粪便

组织：

Sample Name：

Steel

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 75 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：

Blinding：

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

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：

病例记录表

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

Case Record Form

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：

  2025-05-27 09:31:34