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：	ChiCTR2300074868
最近更新日期： Date of Last Refreshed on：	2024-01-11 19:38:04
注册时间： Date of Registration：	2023-08-18 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	信迪利单抗局部用药联合同步放化疗及中子近距离后装治疗一线晚期妇科鳞状细胞癌患者的开放性、单臂、探索性研究
Public title：	An open, one-arm, exploratory study of Sintilimab topical medication combined with concurrent radiotherapy and chemotherapy and neutron brachytherapy in the treatment of patients with first-line advanced gynecological squamous cell carcinoma
注册题目简写：
English Acronym：
研究课题的正式科学名称：	信迪利单抗局部用药联合同步放化疗及中子近距离后装治疗一线晚期妇科鳞状细胞癌患者的开放性、单臂、探索性研究
Scientific title：	An open, one-arm, exploratory study of Sintilimab topical medication combined with concurrent radiotherapy and chemotherapy and neutron brachytherapy in the treatment of patients with first-line advanced gynecological squamous cell carcinoma
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：	李晓玲	研究负责人：	李晓玲
Applicant：	Li XiaoLing	Study leader：	Li XiaoLing
申请注册联系人电话： Applicant telephone：	+86 139 3651 9200	研究负责人电话： Study leader's telephone：	+86 139 3651 9200
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：	Athena2111@163.com	研究负责人电子邮件： Study leader's E-mail：	Athena2111@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：	黑龙江省哈尔滨市南岗区哈双路235号	研究负责人通讯地址：	黑龙江省哈尔滨市南岗区哈双路235号
Applicant address：	235 Hashuang Road, Nangang District, Harbin, Heilongjiang, China	Study leader's address：	235 Hashuang Road, Nangang District,Harbin, Heilongjiang, China
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：	黑龙江省农垦总局总医院
Applicant's institution：	Heilongjiang General Hospital of General Bureau of Agricultural Reclamation
研究负责人所在单位：	黑龙江省农垦总局总医院
Affiliation of the Leader：	Heilongjiang General Hospital of General Bureau of Agricultural Reclamation

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：	NKZYY-2020-025	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：	黑龙江省农垦总局总医院伦理委员会
Name of the ethic committee：	Ethics Committee of Heilongjiang General Hospital of General Bureau of Agricultural Reclamation
伦理委员会批准日期： Date of approved by ethic committee：	2021-01-06 00:00:00
伦理委员会联系人：	王利达
Contact Name of the ethic committee：	Wang Lida
伦理委员会联系地址：	黑龙江省哈尔滨市南岗区哈双路235号
Contact Address of the ethic committee：	235 Hashuang Road, Nangang District, Harbin, Heilongjiang, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 186 8686 3660	伦理委员会联系人邮箱： Contact email of the ethic committee：	427334@qq.com

研究实施负责（组长）单位：

黑龙江省农垦总局总医院

Primary sponsor：

Heilongjiang General Hospital of General Bureau of Agricultural Reclamation

研究实施负责（组长）单位地址：

黑龙江省哈尔滨市南岗区哈双路235号

Primary sponsor's address：

235 Hashuang Road, Nangang District, Harbin, Heilongjiang, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	黑龙江省	市(区县)：	哈尔滨市
Country：	China	Province：	Heilongjiang	City：	Harbin
单位(医院)：	黑龙江省农垦总局总医院	具体地址：	哈尔滨市南岗区哈双路235号
Institution hospital：	General Hospital of Heilongjiang Agricultural Reclamation Bureau	Address：	235 Hashuang Road, Nangang District, Harbin, Heilongjiang, China

经费或物资来源：

自费

Source(s) of funding：

Self-funded

研究疾病：

妇科鳞状细胞癌

Target disease：

Gynecological Squamous Cell Carcinoma

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：

单臂

Study design：

Single arm

研究目的：

评估信迪利单抗局部用药联合同步放化疗及中子近距离后装治疗一线晚期妇科鳞状细胞癌患者的疗效。

Objectives of Study：

To evaluate the efficacy of Sintilimab topical combined with concurrent radiotherapy and chemotherapy and neutron brachytherapy in the treatment of patients with first-line advanced gynecological squamous cell carcinoma.

药物成份或治疗方案详述：

依据患者实际情况，选择放疗、化疗、中子近距离后装治疗，或以上两种、三种联合治疗方案。治疗期间同步应用信迪利单抗治疗。应用药物：信迪利单抗注射液 -规格：100 mg/10 ml -给药方法：100mg，局部用药，每3周一个治疗周期，每个周期的第1天给药，共4个治疗周期。局部用药方案：可依据患者病灶部位、大小及周围侵犯程度等具体情况酌情给药。宫颈鳞状细胞癌患者行宫颈多点、均匀、等量注射给药，同时针对受侵宫旁组织注射给药；阴道鳞状细胞癌及外阴鳞状细胞癌患者给予病灶及瘤周（1~2cm）多点、均匀、等量注射给药。持续给药直至疾病进展、死亡、毒性不能耐受、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。

Description for medicine or protocol of treatment in detail：

According to the actual situation of the patient, choose radiotherapy, chemotherapy, neutron brachytherapy, or a combination of the above two or three treatment options. Simultaneous application of Sintilizumab during treatment. Application drug: Sintilizumab injection -Specification: 100 mg/10 ml -Administration method: 100 mg, topical, a treatment cycle every 3 weeks, administration on the first day of each cycle, a total of 4 treatment cycles. Local medication regimen: The medication can be administered according to the specific conditions of the patient's lesion site, size, and degree of surrounding invasion. Patients with squamous cell carcinoma of the cervix were given multiple, uniform and equal injections of the cervix, and at the same time injected into the invaded parauterine tissue; patients with vaginal squamous cell carcinoma and vulvar squamous cell carcinoma were given the lesion and around the tumor (1~ 2cm) Multi-point, uniform and equal injection administration. Continue the administration until the disease progresses, death, toxicity is intolerable, informed consent is withdrawn, new anti-tumor treatment is started, or treatment is terminated for other reasons specified in the plan.

纳入标准：

1.理解研究步骤和内容，并自愿签署书面知情同意书；
2.18岁~90岁女性；
3.ECOG PS评分为0-2；
4.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；
5.经病理组织学确诊的晚期妇科鳞状细胞癌（包括宫颈鳞状细胞癌、阴道鳞状细胞癌及外阴鳞状细胞癌），不适合手术；
6.既往未接受过针对宫颈鳞状细胞癌、阴道鳞状细胞癌及外阴鳞状细胞癌的任何系统性抗肿瘤治疗；
7.允许患者接受姑息性放疗，但放疗结束时间在首次研究药物给药前7天内；
8.有充分的器官和骨髓功能，筛查所做的实验室检查必须符合下列标准： 
（1）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>6g/dL；
（2）近14天内未使用粒细胞集落刺激因子的情况下，中性粒细胞绝对计数（ANC）≥1.5×10^9/L；
（3）近14天内未输血情况下，血小板（PLT）≥9×10^9/L；
（4）总胆红素（TBIL）≤1.5×正常值上限（ULN）（Gilbert 综合征允许 ≤3×ULN）；
（5）谷丙转氨酶（ALT）和谷草转氨酶（AST）≤2.5×ULN（如存在肝脏转移，则ALT 和AST≤5×ULN）；
（6）血清肌酐（ Cr ） ≤ 1.5×ULN 或内生肌酐清除率≥ 50mL/min （Cockcroft-Gault 公式）；
（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）； 
9.预计生存超过3个月；
10.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；
11.如存在受孕风险，所有受试者均需在整个治疗期间直至治疗末次研究药物给药后120天内采用年失败率低于1%的避孕措施；
12.受试者必须同意治疗阶段采集血液样本，并同意提供足够的肿瘤组织样本，用于PD-L1表达检测。包括存档的肿瘤样本（石蜡块或数量满足本研究所规定检测要求的未染色切片）；若没有存档的肿瘤组织样本，受试者同意接受肿瘤病灶再活检。

Inclusion criteria

1. Understand the steps and content of the study, and voluntarily sign a written informed consent;
2. Aged 18-90 years, female; 
3. ECOG PS score 0-2;
4. According to solid tumors efficacy evaluation standard (RECIST version 1.1), at least one imaging measurable lesion;
5. Advanced gynecological squamous cell carcinoma (including cervical squamous cell carcinoma, vaginal squamous cell carcinoma and vulvar squamous cell carcinoma) confirmed by histopathology Cancer), not suitable for surgery;
6. Have not previously received any systemic anti-tumor treatment for cervical squamous cell carcinoma, vaginal squamous cell carcinoma and vulvar squamous cell carcinoma;
7. Allow patients to receive palliative radiotherapy, but radiotherapy The end time is within 7 days before the first study drug administration;
8. With sufficient organ and bone marrow function, the laboratory tests performed by the screening must meet the following standards:
(1) No blood transfusion or use of erythropoietin in the past 14 days Under the condition of hemoglobin > 6g/dL;
(2) Absolute neutrophil count (ANC) >= 1.5×10^9/L if granulocyte colony stimulating factor has not been used in the past 14 days;
(3) If there is no blood transfusion in the past 14 days, Platelet (PLT) >= 9×10^9/L;
(4) Total bilirubin (TBIL) <= 1.5×upper limit of normal (ULN) (Gilbert syndrome allows <= 3×ULN);
(5) Alanine aminotransferase (ALT) and aspartate Transaminase (AST) <= 2.5 × ULN (if there is liver metastasis, ALT and AST <= 5 × ULN);
(6) Serum creatinine (Cr) <= 1.5 × ULN or endogenous creatinine clearance rate >= 50mL/min (Cockcroft-Gault formula );
(7) Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5 times ULN;
(8) Normal thyroid function is defined as thyroid-stimulating hormone (TSH) within the normal range; if the baseline TSH is out of the normal range, subjects whose total T3 (or FT3) and FT4 are within the normal range can also be included in the group;
(9) Myocardial enzyme spectrum is within the normal range (if the investigator comprehensively judges that the simple laboratory abnormality is not clinically significant, it is also allowed to be included);
9. Expected to survive more than 3 months;
10. For female subjects of childbearing age, Received a urine or serum pregnancy test within 3 days before receiving the first study drug administration (day 1 of cycle 1) and the result was negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-bearing age are defined as at least 1 year after menopause, or have undergone surgical sterilization or hysterectomy;
11. If there is a risk of conception, all subjects must be used during the entire treatment period until 120 days after the last study drug administration. Contraceptive measures with an annual failure rate of less than 1%;
12. Subjects must agree to collect blood samples during the treatment phase and agree to provide sufficient tumor tissue samples for PD-L1 expression detection. Including archived tumor samples (paraffin blocks or unstained sections with a quantity that meets the testing requirements of this research institute); if there is no archived tumor tissue sample, the subject agrees to receive a biopsy of the tumor lesion.

排除标准：

1.首次给药前5年内诊断为妇科鳞状细胞癌之外的其他恶性疾病（不包括经过根治的皮肤基底细胞癌、皮肤鳞状上皮癌、和/或经过根治性切除的原位癌）； 2.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使用过研究器械治疗； 3.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； 4.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（包括胸腺肽、干扰素、白介素，除外为控制胸水局部使用）系统性全身治疗； 5.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； 6.研究首次给药前7天内正在接受全身性糖皮质激素治疗（不包括喷鼻、吸入性或其他途径的局部糖皮质激素）或任何其他形式的免疫抑制疗法；注：允许使用生理剂量的糖皮质激素（≤10 mg/天的泼尼松或等效药物）； 7.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患者可以入组）； 8.已知异体器官移植（角膜移植除外）或异体造血干细胞移植； 9.已知对本研究药物信迪利单抗活性成分或辅料过敏者； 10.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）； 11.已知人类免疫缺陷病毒（HIV）感染史（即HIV 1/2抗体阳性）； 12.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：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治疗期间接受抗HBV治疗避免病毒再激活；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；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）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；（4）血压控制不理想（收缩压＞140 mmHg，舒张压＞90 mmHg）；（5）活动性肺结核；（6）存在需要全身性治疗的活动性或未能控制的感染；（7）存在临床活动性憩室炎、腹腔脓肿、胃肠道梗阻；（8）肝脏疾病如肝硬化、失代偿性肝病、急性或慢性活动性肝炎；（9）糖尿病控制不佳（空腹血糖（FBG）＞10mmol/L）；（10）尿常规提示尿蛋白≥++，且证实24小时尿蛋白定量＞1.0 g者；（11）存在精神障碍且无法配合治疗的患者； 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：

1. Other malignant diseases (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and / or cancer in situ after radical resection) were diagnosed within 5 years before the first administration; 2. Currently participating in interventional clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration; 3. Having received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137); 4. Received systemic treatment with Chinese patent medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control pleural effusion) within 2 weeks before the first administration; 5. Active autoimmune diseases requiring systemic treatment (such as the use of disease relief drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Replacement therapy (such as thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic therapy; 6. The study was receiving systemic glucocorticoid therapy (excluding local glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 7 days before the first administration; Note: physiological dose of Glucocorticoid (<= 10 mg / day of prednisone or equivalent) is allowed; 7. Patients with clinically uncontrollable pleural effusion / peritoneal effusion (those who do not need drainage or whose effusion does not increase significantly after 3 days of drainage can be enrolled); 8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. Those who are known to be allergic to the active ingredients or excipients of sindilimab; 10. Not fully recovered from the toxicity and / or complications caused by any intervention (i.e. <= grade 1 or reaching baseline, excluding fatigue or hair loss) before the start of treatment; 11. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1 / 2 antibody positive); 12. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number higher than the upper limit of the normal value in the laboratory of the research center); Note: hepatitis B patients who meet the following criteria can also be included in the study; Before the first administration, if the HBV viral load is less than 1000 copies/ml (200 IU/ml), subjects should receive anti HBV treatment throughout the entire study treatment period to avoid virus reactivation; For subjects with anti HBc (+), HBsAg (-), anti HBs (-), and HBV viral load (-), preventive anti HBV treatment is not required, but virus reactivation needs to be closely monitored; Active HCV infected subjects (with positive HCV antibodies and HCV-RNA levels above the detection limit); 13.Inoculate the live vaccine within 30 days before the first administration (1st cycle, 1st day); Note: It is allowed to receive inactivated viral vaccines for seasonal influenza within 30 days before the first administration; However, it is not allowed to receive live attenuated influenza vaccines using intranasal medication; 14. Pregnant or lactating women; 15. There are any serious or uncontrollable systemic diseases, such as: (1) The resting electrocardiogram exhibits significant and difficult to control abnormalities in rhythm, conduction, or morphology, such as complete left bundle branch block, second degree or above heart block, ventricular arrhythmias, or atrial fibrillation; (2) Unstable angina, congestive heart failure, chronic heart failure with a New York Heart Association (NYHA) rating of >= 2; (3) Have experienced any arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment for treatment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack; (4) Poor blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); (5) Active pulmonary tuberculosis; (6) There are active or uncontrollable infections that require systemic treatment; (7) Presence of clinically active diverticulitis, abdominal abscess, and gastrointestinal obstruction; (8) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; (9) Poor control of diabetes (FBG > 10mmol/L); (10) Urinary routine examination indicates that urine protein is >= ++, and it is confirmed that 24-hour urine protein quantification is greater than 1.0g; (11) Patients with mental disorders who are unable to cooperate with treatment; 16. Medical history or evidence of illness that may interfere with the trial results, hinder participants from participating in the entire study, abnormal treatment or laboratory test values, or other situations that the researcher believes are not suitable for enrollment. The researcher believes that there are other potential risks that are not suitable for participating in this study.

研究实施时间：

Study execute time：

从 From 2021-01-06 00:00:00至 To 2023-06-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2021-01-06 00:00:00 至 To 2023-02-28 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	20
Group：	Experimental group	Sample size：	20
干预措施：	信迪利单抗局部用药	干预措施代码：
Intervention：	Topical use of Sintilimab	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	黑龙江	市(区县)：	哈尔滨
Country：	China	Province：	Heilongjiang	City：	Harbin
单位(医院)：	黑龙江省农垦总局总医院	单位级别：	三级甲等
Institution hospital：	General Hospital of Heilongjiang Agricultural Reclamation Bureau	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	客观缓解率（ORR）	指标类型：	主要指标
Outcome：	Objective response rate (ORR)	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	无进展生存期（PFS）	指标类型：	次要指标
Outcome：	Progression-free survival (PFS)	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（DCR）	指标类型：	次要指标
Outcome：	Disease control rate (DCR)	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（DOR）	指标类型：	次要指标
Outcome：	Duration of remission (DOR)	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（OS）	指标类型：	次要指标
Outcome：	Overall survival (OS)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	评估信迪利单抗联合含铂双药化疗的安全性和耐受性：包括不良事件（AE）和严重不良事件（SAE）的发生率，AE/SAE导致治疗终止的发生率	指标类型：	次要指标
Outcome：	To assess the safety and tolerability of sintilimab combined with platinum-containing dual-agent chemotherapy: including the incidence of adverse events (AE) and serious adverse events (SAE), and the incidence of AE/SAE leading to treatment discontinuation	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：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	90	岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

单臂探索性研究，无随机对照组。

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

One-arm exploratory study, no randomized control group.

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）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是Yes
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）：	试验完成后6个月共享数据，网络平台共享，ResMan (http://www.medresman.org.cn/login.aspx)。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	6 months after the trial is completed, data sharing, network platform sharing, ResMan (http://www.medresman.org.cn/login.aspx).
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, CRF
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2023-08-18 09:59:33