ChiCTR2200067045 版本V1.1 版本创建时间2023/05/19 11:48:14 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：

 ChiCTR2200067045 

最近更新日期：

Date of Last Refreshed on：

 2022-12-26 09:38:40 

注册时间：

Date of Registration：

 2022-12-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

信迪利单抗联合安罗替尼治疗局部晚期或转移性甲状腺未分化癌患者的前瞻性临床研究

Public title：

Prospective clinical study of sintilimab combined with anlotinib in the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

信迪利单抗联合安罗替尼治疗局部晚期或转移性甲状腺未分化癌患者的前瞻性临床研究

Scientific title：

Prospective clinical study of sintilimab combined with anlotinib in the treatment of patients with locally advanced or metastatic anaplastic thyroid 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：

桂琳 

研究负责人：

桂琳 

Applicant：

Guilin 

Study leader：

Guilin 

申请注册联系人电话：

Applicant telephone：

 13520372817

研究负责人电话：

Study leader's
telephone：

13520372817

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：

 guilindoctor@126.com

研究负责人电子邮件：

Study leader's E-mail：

 guilindoctor@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：

北京市朝阳区潘家园南里17号

研究负责人通讯地址：

北京市朝阳区潘家园南里17号

Applicant address：

No. 17, Panjiayuan Nanli, Chaoyang District, Beijing，P.R. China

Study leader's address：

No. 17, Panjiayuan Nanli, Chaoyang District, Beijing，P.R. China

申请注册联系人邮政编码：

Applicant postcode：

 100021

研究负责人邮政编码：

Study leader's postcode：

 100021

申请人所在单位：

中国医学科学院肿瘤医院

Applicant's institution：

Cancer Hospital Chinese Academy of Medical Science

研究负责人所在单位：

中国医学科学院肿瘤医院

Affiliation of the Leader：

Cance Hospital Chinese Academy of Medical Science

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：

 22/205-3407

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：

国家癌症中心/中国医学科学院北京协和医院肿瘤医院伦理委员会

Name of the ethic committee：

Ethics Committee of National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-05-12 00:00:00

伦理委员会联系人：

徐震纲

Contact Name of the ethic committee：

Zhengang Xu

伦理委员会联系地址：

北京市朝阳区潘家园南里17号

Contact Address of the ethic committee：

No. 17, Panjiayuan Nanli, Chaoyang District, Beijing，P.R. China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 87788495

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：

中国医学科学院肿瘤医院

Primary sponsor：

Cancer Hospital Chinese Academy of Medical Science

研究实施负责（组长）单位地址：

北京市朝阳区潘家园南里17号

Primary sponsor's address：

No. 17, Panjiayuan Nanli, Chaoyang District, Beijing，P.R. 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)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中国医学科学院

具体地址：

北京市朝阳区潘家园南里17号

Institution
hospital：

Chinese Academy of Medical Sciences

Address：

No. 17, Panjiayuan Nanli, Chaoyang District, Beijing，P.R. China

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

甲状腺未分化癌患  

Target disease：

anaplastic thyroid 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：

 II期临床试验 

Study phase：

2

研究设计：

单臂 

Study design：

Single arm 

研究目的：

主要研究目标 1.评价信迪利单抗联合盐酸安罗替尼胶囊治疗不适合局部治疗的甲状腺未分化癌患者的客观缓解率（ORR）； 次要研究目标 1.评价信迪利单抗联合盐酸安罗替尼胶囊治疗不适合局部治疗的甲状腺未分化癌的其他有效性指标，包括疾病控制率（DCR）、缓解持续时间（DOR）、无进展生存期（PFS）、总生存期（OS）； 2.评价信迪利单抗联合盐酸安罗替尼胶囊治疗不适合局部治疗的甲状腺未分化癌患者的安全性及患者生活质量（QoL）； 3.局部晚期患者经过治疗后转化为可手术患者的比率； 探索性研究目标 1.基线患者肿瘤组织PDL1 的表达、多基因分析结果、炎性T细胞基因表达谱分析结果、基线血液学淋巴细胞亚群等与疗效、预后的相关性。  

Objectives of Study：

The main research objective To evaluate the objective response rate (ORR) of sintilimab combined with anlotinib hydrochloride capsules in the treatment of patients with anaplastic thyroid cancer who are not suitable for local therapy; Secondary research objectives ? To evaluate the combination of sintilimab and anlotinib Other efficacy indicators of anlotinib hydrochloride capsules in the treatment of anaplastic thyroid cancer not suitable for local therapy, including disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), overall survival (OS) ); To evaluate the safety and quality of life (QoL) of sintilimab combined with anlotinib hydrochloride capsules in the treatment of patients with anaplastic thyroid cancer who are not suitable for local therapy; Locally advanced patients were converted into operable patients after treatment 3. Exploratory research objectives The correlation between the expression of PDL1 in tumor tissue of patients at baseline, the results of polygenic analysis, the results of gene expression profiling of inflammatory T cells, and the lymphocyte subsets in baseline hematology, etc., with curative effect and prognosis.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

入选标准：
1)自愿签署知情同意书；
2)年龄≥18周岁；
3)组织学确诊的甲状腺未分化癌患者，按照2017年第8版AJCC甲状腺未分化癌TNM分期定义的不可手术IVB期或IVC期；
4)可接受新辅助或辅助或系统性治疗，既往接受的治疗线数不限；
5)根据RECIST 1.1标准，受试者在筛选期影像学检查证实至少存在一个可测量靶病灶(最长径≥10mm的病灶，或者短径≥15mm的淋巴结)，可测量病灶应未接受过放疗等局部治疗（位于既往放疗区域内的病灶，如果证实发生进展，也可选做靶病灶）；
6)受试者筛选期须提供肿瘤组织样本进行PD-L1表达水平检测；
7)美国东部肿瘤协作组(ECOG)评分体能状态为0或1的患者；
8)预计生存期至少3个月；
9)有适宜的器官及造血功能，根据以下实验室检查：
中性粒细胞计数(NEUT#)≥1.5×109/L；
白细胞计数(WBC)≥3.0×109/L；
血小板计数≥100×109/L；
血红蛋白≥90g/L；
血清肌酐≤1.5倍正常值上限(ULN)；
AST和ALT≤3倍ULN；
血清总胆红素(TBIL)≤1.5倍ULN；
国际标准化比率(INR)≤2倍ULN，或活化部分凝血活酶时间(APTT)≤1.5倍ULN(正在接受抗凝血治疗的病人除外)；
10)育龄妇女，须在首次用药前7天内进行血妊娠试验，且结果为阴性。
11)男性受试者和育龄期女受试者应同意在研究治疗期间及末次治疗后至少6个月内同意采用医学上认可的有效的避孕措施（如宫内节育器、避孕药或避孕套）；

Inclusion criteria

Inclusion criteria:
1) Voluntarily signed the informed consent;
2) Age ≥ 18 years;
3) Histologically diagnosed anaplastic thyroid cancer patients, inoperable IVB stage or IVC stage;
4) Acceptable neoadjuvant or adjuvant or systemic therapy, and the number of previous treatment lines is not limited; 5) According to the RECIST 1.1 criteria, the subject has at least one measurable target lesion confirmed by imaging examination during the screening period ( Lesions with a longest diameter ≥ 10 mm, or lymph nodes with a short diameter ≥ 15 mm), measurable lesions should not have received local treatment such as radiotherapy (lesions located in the area of previous radiotherapy, if confirmed to have progressed, can also be selected as target lesions);
6) During the screening period of subjects, tumor tissue samples must be provided for PD-L1 expression level detection;
7) Patients with Eastern Cooperative Oncology Group (ECOG) score performance status of 0 or 1;
8) The expected survival period is at least 3 months;
9) Appropriate organ and hematopoietic function, according to the following laboratory tests: Neutrophil count (NEUT#) ≥ 1.5 G/L; White blood cell count (WBC) ≥ 3.0 G/L; Platelet count ≥ 100 G/L; Hemoglobin≥90 g/L; Serum creatinine≤1.5 x the upper limit of normal (ULN); AST and ALT≤3 x ULN; Serum total bilirubin (TBIL)≤1.5 x ULN; International normalized ratio (INR) ≤ 2 x ULN, or activated partial thromboplastin time (APTT) ≤ 1.5 x ULN (except for patients receiving anticoagulant therapy);
10) Women of childbearing age, must be performed within 7 days before the first dose Blood pregnancy test was negative.
11) Agree to use medically approved effective contraceptive measures (such as intrauterine devices, contraceptives or condoms during the study treatment period and at least 6 months after the last treatment) );

排除标准：

排除标准：
1)适合局部治疗的患者；
2)分化型甲状腺癌或甲状腺髓样癌。由分化型甲状腺癌进展为甲状腺未分化癌患者，当其可测量病灶符合甲状腺未分化癌临床特征（如进展迅速和/或FDG-PET结果阳性等）可以入组；
3)首次使用研究药物前3年内曾诊断为任何其他恶性肿瘤的患者，除外具有低风险转移和死亡风险的恶性肿瘤（5年生存率>90%），如经充分治疗的基底细胞或鳞状细胞皮肤癌或宫颈原位癌及其他原位癌除外；
4)首次给药前4周内接受抗肿瘤单克隆抗体类药物治疗，或4周之前接受的药物所引起的不良事件尚未康复（即≤1级或达到基线水平）；
5)首次给药前2周内接受化疗，或放疗，或小分子靶向治疗，或之前接受的药物所引起的不良事件尚未康复（即≤1级或达到基线水平）。注：有≤2级神经病变或≤2级脱发的受试者除外；
6)任何影响患者口服药物的因素，比如无法吞咽、胃肠道切除术后、慢性腹泻和肠梗阻等；
7)经研究者判断有大出血风险；
8)曾接受抗PD-1或PD-L1、CTLA-4等其它免疫检查点抑制剂疗法的患者；
9)已知或筛选期检查发现患有中枢神经系统（CNS）转移和/或癌性脑膜炎的患者；
10)患有活动性自身免疫性疾病（银屑病除外），并在过去2年中需要全身性治疗（即使用皮质类固醇或免疫抑制药物）。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皮质类固醇替代疗法）除外；
11)预期在首次用药前 28天内或本研究期间有重大手术的患者。（不包括诊断性的外科手术）。重大手术的定义：术后至少需要3周恢复时间，才能够接受本研究治疗的手术；
12)入组前14天内或研究期间需要接受全身用皮质类固醇(剂量相当于>10mg 强的松/天)或其他免疫抑制药物治疗的受试者；以下情况允许入组： 允许受试者使用局部外用或吸入型糖皮质激素；
13)允许短期(≤7天)使用糖皮质激素进行预防或治疗非自身免疫性的过敏性疾病；
14)现患有间质性肺病或肺炎，肺纤维化，急性肺部疾病等；
15)受试者具有未能良好控制的心血管疾病，包括但不限于：如（1）NYHA II级以上心力衰竭（2）不稳定型心绞痛（3）1年内发生过心肌梗死（4）有临床意义的室上性或室性心律失常未经临床干预或临床干预后仍控制不佳；（5）在静息状态下，心电图（ECG）检查得出的平均校正QT间期（QTc）>470 msec（第1次异常时，在48 h内复测1次，以2次平均结果计算）。各种有临床意义的心律、传导、静息ECG形态异常，例如完全性左束支传导阻滞，III度传导阻滞，II度传导阻滞，PR间期>250 msec。可能增加QTc延长风险或心律失常事件风险的各种因素，例如冠心病，心力衰竭，低钾血症，先天性长QT综合症，家族史中一级亲属有长QT综合征或不到40岁就不明原因猝死，正在使用任何已知QT间期延长的药物；血压控制不理想的（收缩压＞150 mmHg，舒张压＞100 mmHg）患者；患有I级以上心肌缺血或心肌梗塞；
16)存在任何重度和/或未能控制的疾病的患者，包括但不局限于以下情况：活动性或未能控制的严重感染(≥CTC AE 2级感染)；肝硬化、失代偿性肝病；肾功能衰竭需要血液透析或腹膜透析；糖尿病控制不佳（空腹血糖（FBG）＞10mmol/L）；尿常规提示尿蛋白≥++，且证实24小时尿蛋白定量＞1.0 g者；
17)入组前6个月内出现血栓性或栓塞性静脉或动脉事件，如脑血管意外，包括一过性脑缺血发作、动脉血栓形成、深静脉血栓形成和肺栓塞等；曾患有出血性疾病或凝血功能异常。
18)活动性肺结核；
19)有感染人类免疫缺陷病毒病史，或患有其他获得性、先天性免疫缺陷疾病，或有器官移植史，或干细胞移植史；
20)存在不可控的、需要反复引流的胸腔积液、心包积液或腹水；
21)慢性乙型肝炎活动期或活动性丙型肝炎患者。乙肝病毒携带者、经药物治疗后稳定的乙肝(DNA 滴度不得高于 500 IU/mL 或拷贝数<2000 copies/mL)和已治愈的丙肝患者(HCV RNA 检测阴性)可以入组；
22)已知受试者既往对大分子蛋白制剂/单克隆抗体，已知对任何试验药物组成成分发生严重过敏反应者(CTCAE v5.0分级大于3级)；
23)首次给药前2周内出现存在需要系统治疗的活动性感染或不可控感染；
24)首次给药前4周内，参加过其他药物临床试验；
25)酒精依赖者或近1年内有吸毒或药物滥用史；
26)既往有明确的神经或精神障碍史，如癫痫、痴呆，依从性差者，或存在外周神经系统障碍者；
27)妊娠期或哺乳期，或预期在试验期内妊娠或生育；
28)首次给药前30天内接受过减毒活疫苗的患者，允许接受针对季节性流感，注射用药的灭活病毒疫苗；但是不允许接受鼻内用药的减毒活流感疫苗；
29) 患有其它不能使用本研究药物的疾病或者代谢机能失调症、或任何体格检查或临床实验室检测显示不能使用研究药物，或者会干扰疾病诊断，或引起并发症；

Exclusion criteria：

Exclusion criteria:
1) Patients who are suitable for local treatment;
2) Differentiated thyroid cancer or medullary thyroid cancer. Patients who have progressed from differentiated thyroid cancer to anaplastic thyroid cancer can be enrolled if their measurable lesions conform to the clinical characteristics of anaplastic thyroid cancer (such as rapid progression and/or positive FDG-PET results, etc.);
3) Before the first use of the study drug Patients diagnosed with any other malignancy within 3 years, excluding malignancies with low risk of metastasis and mortality (5-year survival >90%), such as adequately treated basal cell or squamous cell skin cancer or cervical in situ Carcinoma and other carcinomas in situ are excluded;
4) Received anti-tumor monoclonal antibody therapy within 4 weeks before the first dose, or the adverse events caused by the drugs received before 4 weeks have not recovered (ie ≤ grade 1 or reach the baseline level );
5) Received chemotherapy, or radiotherapy, or small molecule targeted therapy within 2 weeks before the first dose, or the adverse events caused by the previously received drugs have not recovered (ie, ≤ grade 1 or reached the baseline level). Note: Subjects with ≤ grade 2 neuropathy or ≤ grade 2 alopecia are excluded;
6) Any factors that affect the patient's oral medication, such as inability to swallow, post gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.;
7) After the investigator judges that there is a risk of major bleeding;
8) Patients who have received anti-PD-1 or other immune checkpoint inhibitor therapy such as PD-L1 and CTLA-4; ) patients with metastatic and/or cancerous meningitis;
10) with active autoimmune disease (except psoriasis) and requiring systemic therapy (ie, corticosteroids or immunosuppressive drugs) in the past 2 years. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is excluded;
11) Patients who are expected to have major surgery within 28 days before the first dose or during this study. (excluding diagnostic surgery). Definition of major surgery: At least 3 weeks of recovery time is required after surgery to be able to accept the surgery treated in this study;
12) Systemic corticosteroids (dose equivalent to >10mg prednisone/day) are required within 14 days before enrollment or during the study period ) or other immunosuppressive drugs; the following conditions are allowed to enroll: Allow subjects to use topical or inhaled glucocorticoids;
13) Allow short-term (≤7 days) use of glucocorticoids for prevention or treatment of non- Autoimmune allergic diseases;
14) Existing interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, etc.;
15) Subjects with uncontrolled cardiovascular diseases, including but not limited to: Such as (1) NYHA class II or above heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia without clinical intervention or still after clinical intervention Poor control; (5) In the resting state, the average corrected QT interval (QTc) obtained by the electrocardiogram (ECG) examination is >470 msec (for the first abnormality, repeat the test once within 48 hours, with 2 averaged results). Various clinically significant abnormalities of cardiac rhythm, conduction, and resting ECG morphology, such as complete left bundle branch block, third-degree conduction block, second-degree conduction block, PR interval >250 msec. Various factors that may increase the risk of QTc prolongation or risk of arrhythmic events, such as coronary heart disease, heart failure, hypokalemia, congenital long QT syndrome, family history of first-degree relatives with long QT syndrome or less than 40 years of age Sudden death of unknown cause, using any known QT interval prolonging drugs; patients with unsatisfactory blood pressure control (systolic blood pressure > 150 mmHg, diastolic blood pressure > 100 mmHg); suffering from myocardial ischemia or myocardial infarction above grade I;
16 ) patients with any severe and/or uncontrolled disease, including but not limited to the following: active or uncontrolled severe infection (≥CTC AE grade 2 infection); cirrhosis, decompensated liver disease; Renal failure requiring hemodialysis or peritoneal dialysis; poor control of diabetes (fasting blood glucose (FBG)>10mmol/L); urine routine indicating urine protein ≥++, and confirmed 24-hour urine protein quantification>1.0 g;
17) Entry Thrombotic or embolic venous or arterial events, such as cerebrovascular accidents, including transient ischemic attack, arterial thrombosis, deep vein thrombosis, and pulmonary embolism, etc. occurred within the previous 6 months; ever had bleeding disorders or abnormal coagulation function.
18) Active pulmonary tuberculosis;
19) Have a history of infection with human immunodeficiency virus, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation, or a history of stem cell transplantation;
20) There is uncontrollable, needing repeated drainage pleural effusion, pericardial effusion or ascites;
21) patients with active chronic hepatitis B or active hepatitis C. Hepatitis B virus carriers, stable hepatitis B after drug treatment (DNA titer not higher than 500 IU/mL or copy number <2000 copies/mL) and cured hepatitis C patients (HCV RNA test negative) can be enrolled;
22) The subjects are known to have severe allergic reactions to macromolecular protein preparations/monoclonal antibodies in the past, or to any component of the test drug (CTCAE v5.0 grade is greater than grade 3);
23) Appears within 2 weeks before the first dose Active infection or uncontrollable infection requiring systemic treatment;
24) Participated in clinical trials of other drugs within 4 weeks before the first administration;
25) Alcohol-dependent or a history of drug abuse or drug abuse within the past 1 year;
26) Previous history of drug use or drug abuse A clear history of neurological or psychiatric disorders, such as epilepsy, dementia, those with poor compliance, or those with peripheral nervous system disorders;
27) Pregnancy or lactation, or expected pregnancy or childbirth during the test period;
28) Before the first dose 30 Patients who have received live attenuated vaccines within the past few days are allowed to receive inactivated virus vaccines for seasonal influenza by injection; however, they are not allowed to receive live attenuated influenza vaccines for intranasal administration; suffering from other diseases for which the study drug cannot be used or Metabolic dysfunction, or any physical examination or clinical laboratory test that indicates inability to use the study drug, or which would interfere with the diagnosis of the disease, or cause complications;
29) Suffer from other diseases or metabolic disorders that cannot use the study drug, or any physical examination or clinical laboratory test shows that the study drug cannot be used, or will interfere with disease diagnosis, or cause complications.

研究实施时间：

Study execute time：

从 From 2022-12-26 00:00:00至 To 2025-06-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-12-26 00:00:00 至 To 2025-06-01 00:00:00

干预措施：

Interventions：

组别：

单臂

样本量：

 28

Group：

single arm

Sample size：

干预措施：

信迪利单抗联合盐酸安罗替尼胶囊

干预措施代码：

Intervention：

sintilimab combined with anlotinib

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 中国医学科学院肿瘤医院 

单位级别：

 三级甲等 

Institution
hospital：

Cancer Hospital Chinese Academy of Medical Science

Level of the institution：

Level III class 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：

疾病控制率（DCR）

指标类型：

主要指标

Outcome：

disease control rate (DCR)

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：

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：

生存期 （OS)

指标类型：

主要指标

Outcome：

overall survival (OS)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良事件 （AE）

指标类型：

主要指标

Outcome：

adverse events

Type：

Primary 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：

肿瘤组织样本

组织：

甲状腺

Sample Name：

tumor tissue sample

Tissue：

thyroid

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：

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 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）：

single arm

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

单臂

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：

Blinding：

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）：

不分享

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

No sharing

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：

无/No

注册人：

Name of Registration：

  2022-12-26 09:38:12