ChiCTR2400085408 版本V1.0 版本创建时间2024/06/06 17:03:41 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：

ChiCTR2400085408 

最近更新日期：

Date of Last Refreshed on：

2024-06-06 17:03:29 

注册时间：

Date of Registration：

2024-06-06 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

基于肿瘤微环境TCF-1+CD8+T细胞的PD-1单抗联合化疗±中药新辅助治疗局部晚期中下段长病变食管鳞癌的前瞻性临床研究

Public title：

Prospective clinical study of PD-1 monoclonal antibody based on tumor microenvironment TCF-1+CD8+T cells combined with chemotherapy plus neoadjuvant treatment with traditional Chinese medicine for locally advanced middle and lower segment long lesions of esophageal squamous cell carcinoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于肿瘤微环境TCF-1+CD8+T细胞的PD-1单抗联合化疗±中药新辅助治疗局部晚期中下段长病变食管鳞癌的前瞻性临床研究

Scientific title：

Prospective clinical study of PD-1 monoclonal antibody based on tumor microenvironment TCF-1+CD8+T cells combined with chemotherapy plus neoadjuvant treatment with traditional Chinese medicine for locally advanced middle and lower segment long lesions of esophageal squamous cell carcinoma

研究课题代号(代码)：

Study subject ID：

 ZRJY2021-TD05

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：

王瑞韬 

研究负责人：

娄彦妮 

Applicant：

Ruitao Wang 

Study leader：

Yanni Lou 

申请注册联系人电话：

Applicant telephone：

+86 189 9108 1592

研究负责人电话：

Study leader's telephone：

+86 10 8420 5733

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：

1050278500@qq.com

研究负责人电子邮件：

Study leader's E-mail：

louyanni@zryhyy.com.cn

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：

中国北京市朝阳区樱花东路2号

研究负责人通讯地址：

中国北京市朝阳区樱花东路2号

Applicant address：

2 East Yinghua Road, Chaoyang District, Beijing, China

Study leader's address：

2 East Yinghua Road, Chaoyang District, Beijing, 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：

中日友好医院

Applicant's institution：

China-Japan Friendship Hospital

研究负责人所在单位：

中日友好医院

Affiliation of the Leader：

China-Japan Friendship Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2023-KY-189

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：

中日友好医院临床研究伦理委员会

Name of the ethic committee：

Ethics Committee of Clinical Research, China-Japan Friendship Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2023-09-01 00:00:00

伦理委员会联系人：

陈燕芬

Contact Name of the ethic committee：

Yanfen Chen

伦理委员会联系地址：

北京市朝阳区樱花园东街2号

Contact Address of the ethic committee：

2 Yinhuayuan Street East, Chaoyang District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 8420 6086

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：

中日友好医院

Primary sponsor：

China-Japan Friendship Hospital

研究实施负责（组长）单位地址：

中国北京市朝阳区樱花东路2号

Primary sponsor's address：

2 East Yinghua Road, Chaoyang District, Beijing, 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

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中日友好医院

具体地址：

中国北京市朝阳区樱花东路2号

Institution
hospital：

China-Japan Friendship Hospital

Address：

2 East Yinghua Road, Chaoyang District, Beijing, China

经费或物资来源：

中日友好医院

Source(s) of funding：

China-Japan Friendship Hospital

Target disease：

Esophageal squamous cell carcinoma with locally advanced middle and lower segment long lesions

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

1）本研究针对局部晚期食管鳞癌患者中预后较差的“长病变”患者，观察PD-1单抗联合化疗新辅助治疗，评价其安全性与临床疗效，对这一类临床常见的患者人群制定更优治疗策略具有实际借鉴意义与参考价值； 2)对肿瘤微环境中“CD8+T淋巴细胞TCF-1+/TCF-1-≤1”的可能为免疫治疗“低应答”的人群，联合应用中药扶正通膈方，评价并比较其安全性与临床疗效，有益于探索筛选新辅助免疫治疗的优势人群，为临床采用中西医结合协同增效、精准施治提供科学依据。  

Objectives of Study：

1) In this study,aiming at the "long lesion"patients with poor prognosis in locally advanced esophageal squamous cell carcinoma,we observed the new adjuvant therapy of PD-1 monoclonal antibody combined with chemotheray,and clinical efficacy,which has practical reference signifiicance and reference value for formulating better treatment strategies for this kind of clinically common patients. 2) For the people with "CD8+T lymphocyte TCF-1+/TCF-1-≤1" in tumor microenvironment who may be "low response" to immunotherapy, the traditional Chinese medicine Fuzheng Tongge Recipe was combined, and its safety and clinical efficacy were evaluated and compared, which was helpful to explore and screen the dominant groups of new adjuvant immunotherapy and provide scientific basis for clinical application of synergistic and accurate treatment of integrated traditional Chinese and western medicine.

药物成份或治疗方案详述：

本研究项目拟纳入局部晚期中下段长病变的食管鳞癌患者，采用PD-1单抗联合化疗新辅助治疗，并针对其中TCF-1+CD8+T细胞在肿瘤微环境低表达者加用中药扶正通膈方，评价并比较其临床疗效与安全性。 

Description for medicine or protocol of treatment in detail：

In this research project, patients with esophageal squamous cell carcinoma with locally advanced middle and lower segment lesions were included, and the new adjuvant therapy of PD-1 monoclonal antibody combined with chemotherapy was adopted. For those with low expression of TCF-1+CD8+T cells in tumor microenvironment, Fuzheng Tongge recipe was added, and its clinical efficacy and safety were evaluated and compared. 

纳入标准：

1）18岁≤年龄≤80岁，男女不限； 2）经组织学确诊的局部晚期食管鳞癌，临床分期为：cT1b-cT2N+M0或cT3-cT4a Nany M0，以及可疑累及周围器官但未明确cT4b； 3）食管病变位于胸中下段； 4）电子胃镜或胸部CT提示食管病变长度≥3cm； 5）ECOG PS评分0-1分； 6）有符合RECIST 1.1标准的可测量病灶，且可测量病灶适合手术； 7）预计生存期≥3个月； 8）主要脏器功能正常，无严重血液、心、肺、肝、肾、骨髓等功能异常和免疫缺陷疾病。实验室检查符合下列要求： ① 血红蛋白（Hb）≥90g/L； ② 白细胞 (WBC) ≥3.0×109/L；中性粒细胞计数（NEUT）≥ 1.5×109/L； ③ 血小板计数（PLT）≥100×109/L； ④ 血清肌酐(SCr) ≤ 1.5倍正常值上限（ULN）或肌酐清除率≥50 ml/min（Cockcroft-Gault公式）； ⑤ 总胆红素（TBIL）≤ 1.5倍正常值上限（ULN）； ⑥ 谷草转氨酶（AST）或谷丙转氨酶（ALT）水平≤ 2.5倍正常值上限（ULN）； ⑦ 尿蛋白<2+；如果尿蛋白≥2+，则24小时尿蛋白定量显示蛋白质必须≤1g； 9）凝血功能正常，无活动性出血和血栓形成疾病： ① 国际标准化比值INR≤1.5×ULN； ② 部分凝血活酶时间APTT≤1.5×ULN； ③ 凝血酶原时间PT≤1.5ULN； 10）肺功能正常或轻中度异常（VC%＞60%、FEV1＞1.2L、FEV1%＞40%、DLco＞40%），可耐受食管癌切除术； 11）有生育能力的女性受试者须在首次用药前72小时内进行血妊娠试验，且结果为阴性，且自愿在观察期间和末次给予试验药物后120天内采用适当的方法避孕；对于男性，应为手术绝育或同意在观察期间和末次给予试验药物后120天内采用适当方法避孕； 12）受试者自愿加入本研究，并且签署知情同意书（ICF）； 13）预计依从性好者，能按方案要求随访疗效及不良反应。

Inclusion criteria

1.Between 18 and 80 years old, male or female; 2.Histologically confirmed locally advanced esophageal squamous cell carcinoma with clinical stages of cT1b-cT2N+M0 or cT3-cT4aNanyM0, and suspected involvement of surrounding organs without definite cT4b; 3.The esophageal lesion was located in the middle and lower thoracic segment; 4.Electronic gastroscopy or chest CT indicated that the length of esophageal lesion was ≥3cm; 5.ECOG performance status of 0 or 1; 6.Have measurable lesions that meet the RECIST1.1 criteria and are suitable for surgery; 7.Expected survival ≥3 months; 8.The main organs function normally, no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immune deficiency diseases.Laboratory tests meet the following requirements: a.hemoglobin (HGB)≥90g/L; b. White blood cell (WBC)≥3.0×10^9/L, neutrophil count (NEUT)≥1.5x10^9/L; c. Platelet count (PLT)≥100x10^9/L; d. Serum creatinine (SCr)≤1.5x normal upper limit (ULN) or creatinine clearance≥50ml/min (Cockcroft-Gault formula); e. Total bilirubin (TBIL)≤1.5×ULN; f. The level of glutamic oxaloacetic transaminase (AST) or glutamic pyruvic transaminase (ALT)≤2.5×ULN; g. Urinary protein<2+; If urinary protein≥2+, 24-hour urinary protein quantification must be≤1g; 9.Normal coagulation function, no active bleeding and thrombosis: a.International standardized ratio INR ≤ 1.5×ULN; b.partial thromboplastin time APTT ≤ 1.5×ULN; c.prothrombin time PT ≤ 1.5×ULN; 10.Normal pulmonary function or mild to moderate abnormality (VC% > 60%, FEV1 > 1.2L, FEV1% > 40%, DLco > 40%) can tolerate esophagectomy; 11.Fertile female subjects are required to undergo a blood pregnancy test within 72 hours before the first use of the drug, and the results are negative, and they voluntarily use appropriate methods of contraception during the observation period and within 120 days after the last administration of the trial drug; for males, appropriate methods of contraception should be sterilized or agreed to use appropriate methods of contraception during the observation period and within 120 days after the last administration of the trial drug. 12.The subjects voluntarily joined the study and signed the informed consent form (ICF). 13.Those with good compliance were expected to be able to follow up the efficacy and adverse reactions according to the requirements of the regimen.

排除标准：

1）已经或正在接受化疗、放射治疗、靶向或免疫治疗的受试者； 2）患有任何活动性自身免疫疾病或自身免疫疾病史（如间质性肺炎、葡萄膜炎、肠炎、肝炎、垂体炎、血管炎、心肌炎、肾炎等）。以下情况例外：在近2年之内不需系统治疗的白癜风、银屑病，仅需要甲状腺激素替代治疗的甲状腺功能减退以及仅需要胰岛素替代治疗的 I 型糖尿病患者可以入组； 3）受试者进行支气管扩张剂等系统治疗，哮喘控制不满意，不能纳入（在童年期哮喘已完全缓解，成人后无需任何干预的可纳入）； 4）患有先天或后天免疫功能缺陷，如人类免疫缺陷病毒（HIV）感染者，活动性乙型肝炎（HBV DNA ≥ 500 IU/ml），丙型肝炎（丙肝抗体阳性，且HCV-RNA高于分析方法的检测下限）或合并乙肝和丙肝共同感染； 5）首次使用研究药物前14天之内使用过免疫抑制药物，不包括喷鼻和吸入性皮质类固醇或生理剂量的系统性类固醇激素（即不超过10 mg/天强的松龙或同等药物生理学剂量的其他皮质类固醇）； 6）首次给药前4周内或计划在研究期间接种减毒活疫苗； 7）患有高血压病，经降压药物治疗无法降至正常范围者（收缩压≤140 mmHg / 舒张压≤ 90 mmHg）； 8）患有未能控制的心脏临床症状或疾病，如①NYHA II及以上心力衰竭 ②不稳定型心绞痛 ③1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需要临床干预的受试者； 9）首次用药前4周内并发重度感染（如：需要静脉滴注抗生素、抗真菌或抗病毒药物），或在筛选期间/首次给药前出现不明原因的发热＞38.5℃； 10）已知异体器官移植史或异体造血干细胞移植史； 11）怀孕或哺乳期妇女；有生育能力的受试者不愿或无法采取有效避孕措施者； 12）合并除食管癌之外的活动性第二原发恶性肿瘤（除皮肤恶性肿瘤）； 13）存在脑转移的受试者； 14）已知对本方案药物组分有过敏史者； 15）研究者认为不适合纳入的其他情况。

Exclusion criteria：

1.Subjects who have received or are receiving chemotherapy, radiotherapy, targeting or immunotherapy; 2.Suffer from any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, etc.). The exceptions are as follows: vitiligo and psoriasis that do not require systematic treatment in the past 2 years, hypothyroidism who only need thyroid hormone replacement therapy and type I diabetes patients who only need insulin replacement therapy can be included; 3.Subjects are treated with bronchodilators and other systematic treatment, asthma control is not satisfactory, can not be included (asthma has been completely relieved in childhood, adults can be included without any intervention); 4.Suffer from congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500IU / ml), hepatitis C (hepatitis C antibody positive and HCV-RNA is higher than the lower limit of detection by analytical method) or co-infection of hepatitis B and hepatitis C; 5.Immunosuppressive drugs were used within 14 days before the first use of research drugs, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e., corticosteroids not exceeding the physiological dose of 10mg/ or other corticosteroids of the same physiological dose); 6.Live attenuated vaccines were given within 4 weeks before the first administration or during the study period; 7.Patients with hypertension who could not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure ≤ 140mmHg/ diastolic blood pressure ≤ 90 mmHg); 8.Subjects with uncontrolled cardiac clinical symptoms or diseases, such as: a.NYHAII and above heart failure; b.Unstable angina pectoris; c.Had a myocardial infarction within 1 year; d.Subjects with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention 9.Severe infection within 4 weeks before the first administration (e.g., intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever > 38.5 ℃ during screening / before first administration; 10.Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 11.Pregnant or lactating women; fertile subjects unwilling or unable to use effective contraceptive measures. 12.Complicated with active second primary malignant tumor other than esophageal cancer (except skin malignant tumor); 13.Subjects with brain metastasis; 14.Those who are known to have a history of allergy to the drug components of this regimen; 15.Other conditions that the researchers believe are not suitable for inclusion.

研究实施时间：

Study execute time：

从 From 2023-09-01 00:00:00至 To 2024-09-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-09-01 00:00:00 至 To 2024-09-01 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

20

Group：

Intervention group

Sample size：

干预措施：

中药汤剂 扶正通膈方+化疗联合免疫治疗

干预措施代码：

Intervention：

Fuzheng Tongge prescription of traditional Chinese medicine decoction+Chemotherapy combined with immunotherapy

Intervention code：

组别：

对照组

样本量：

20

Group：

Control group

Sample size：

干预措施：

化疗联合免疫治疗

干预措施代码：

Intervention：

Chemotherapy combined with immunotherapy

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)：

中日友好医院 

单位级别：

三甲 

Institution
hospital：

China-Japan Friendship Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

mPR率

指标类型：

主要指标

Outcome：

mPR rate

Type：

Primary indicator

测量时间点：

食管癌根治术后

测量方法：

对于已完成4周期新辅助治疗，经过多学科评估科可行食管癌根治术的受试者，在食管癌根治术后对患者的术后标本行病理检测。术后病理显示≤10%残留存活肿瘤细胞者判断为mPR 。mPR率：取得mPR的病例数/进行手术的例数*100%。

Measure time point of outcome：

After radical resection of esophageal cancer

Measure method：

For the subjects who had completed 4 cycles of neoadjuvant therapy and underwent multidisciplinary evaluation of feasible radical resection of esophageal cancer, the postoperative specimens of the patients were examined pathologically.Postoperative pathology showed that the patients with less than 10% residual tumor cells were judged to be mPR.MPR rate: the number of cases with mPR obtained / the number of cases performed surgery * 100%.

指标中文名：

pCR率

指标类型：

次要指标

Outcome：

pCR rate

Type：

Secondary indicator

测量时间点：

食管癌根治术后

测量方法：

对于已完成4周期新辅助治疗，经过多学科评估科可行食管癌根治术的受试者，在食管癌根治术后对患者的术后标本行病理检测。术后病理显示≤0%残留存活肿瘤细胞者判断为pCR。pCR率：取得pCR的病例数/进行手术的例数*100%。

Measure time point of outcome：

After radical resection of esophageal cancer

Measure method：

For the subjects who had completed 4 cycles of neoadjuvant therapy and underwent multidisciplinary evaluation of feasible radical resection of esophageal cancer, the postoperative specimens of the patients were examined pathologically.Postoperative pathology showed that the patients with less than 0% residual tumor cells were judged to be pCR.PCR rate: the number of cases with pCR obtained / the number of cases performed surgery * 100%.

指标中文名：

pT0率

指标类型：

次要指标

Outcome：

pT0 mate

Type：

Secondary indicator

测量时间点：

食管癌根治术后

测量方法：

对于已完成4周期新辅助治疗，经过多学科评估科可行食管癌根治术的受试者，在食管癌根治术后对患者的术后标本行病理检测。术后组织病理学检查未发现原发肿瘤者判断为pT0 。pT0率：取得pT0的病例数/进行手术的例数*100%。

Measure time point of outcome：

After radical resection of esophageal cancer

Measure method：

For the subjects who had completed 4 cycles of neoadjuvant therapy and underwent multidisciplinary evaluation of feasible radical resection of esophageal cancer, the postoperative specimens of the patients were examined pathologically. If no primary tumor was found by histopathological examination after operation, it was judged to be pT0.PT0 rate: the number of cases with pT0 obtained / the number of cases performed surgery * 100%.

指标中文名：

1年无复发生存率

指标类型：

次要指标

Outcome：

1-year recurrence-free survival rate

Type：

Secondary indicator

测量时间点：

受试者食管癌根治术后一年

测量方法：

对行食管癌根治术一年的患者进行随访，根据其相关检验及影像学检查结果判断是否出现术后复发。无复发定义：术后1年内未出现局部复发或远处转移或因任何原因导致的死亡。1年无复发生存率：术后1年未复发病例数/进行手术的例数*100%。

Measure time point of outcome：

One year after radical resection of esophageal cancer

Measure method：

The patients who underwent radical esophagectomy for one year were followed up, and the postoperative recurrence was judged according to the results of relevant examination and imaging examination. Definition of no recurrence: there was no local recurrence or distant metastasis or death caused by any cause within 1 year after operation. 1-year relapse-free survival rate: the number of non-recurrent cases / the number of patients undergoing surgery 1 year after operation * 100%.

指标中文名：

1年生存率

指标类型：

次要指标

Outcome：

1-year survival rate

Type：

Secondary indicator

测量时间点：

受试者食管癌根治术后一年

测量方法：

对行食管癌根治术一年的患者，随访其生存情况。1年生存率：术后1年仍生存病例数/进行手术的例数*100%。

Measure time point of outcome：

One year after radical resection of esophageal cancer

Measure method：

The survival of patients who underwent radical esophagectomy for one year were followed up. 1-year survival rate: the number of cases still alive 1 year after operation / the number of cases undergoing surgery * 100%.

指标中文名：

围手术期不良事件症发生率

指标类型：

次要指标

Outcome：

Incidence of perioperative complications

Type：

Secondary indicator

测量时间点：

从手术日期到30天后

测量方法：

围手术治疗期间安全性评价：包括手术例数、手术方式、手术时间、术中出血量、术后胸管留置时间、术后开始进食时间、术后疼痛程度，以及术后吻合口瘘、脓胸、乳糜胸、声音嘶哑、吻合口狭窄发生率等。

Measure time point of outcome：

From the date of the operation to 30 days later

Measure method：

Safety evaluation during perioperative treatment: including the number of cases, mode of operation, operation time, intraoperative blood loss, postoperative chest tube indwelling time, postoperative feeding time, postoperative pain degree, and postoperative anastomotic fistula, empyema, chylothorax, hoarseness, incidence of anastomotic stenosis and so on.

指标中文名：

治疗相关不良事件的发生率

指标类型：

次要指标

Outcome：

Incidence of treatment-related adverse events

Type：

Secondary indicator

测量时间点：

从入组起至手术或最后一次给药后至少 90 天。

测量方法：

采用NCI CTCAE 5.0版对不良事件进行评价；记录并评价研究期间发生的全部不良事件。

Measure time point of outcome：

At least 90 days from enrollment to surgery or the last administration.

Measure method：

NCICTCAE5.0 version was used to evaluate the adverse events, and all adverse events occurred during the study period were recorded and evaluated.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

外周血

组织：

Sample Name：

esophagus

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：

食管活检组织标本

组织：

食管

Sample Name：

Esophageal biopsy tissue specimen

Tissue：

esophagus

人体标本去向

 使用后保存  

说明

新辅助治疗前采集患者食管活检组织标本，用于检测肿瘤组织内TCF1CD8+T细胞检测。

Fate of sample：

Preservation after use  

Note：

Esophageal biopsy samples were collected before neoadjuvant therapy to detect TCF1CD8+T cells in tumor tissues.

标本中文名：

手术根治标本

组织：

食管

Sample Name：

Surgical radical specimen

Tissue：

esophagus

人体标本去向

 使用后保存  

说明

受试者根治术标本用于进行术后分子病理检测与部分亚组标本的转录差异分析。

Fate of sample：

Preservation after use  

Note：

Subjects' radical surgery specimens were used for postoperative molecular pathological detection and transcription difference analysis of some subgroups.

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 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:

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

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）：

临床试验公共管理平台 IPD（http://www.medresman.org.cn）。试验结束后 6 个月,采用临床试验公共管理平台并向公众开放查询.

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

ResMan IPD (http://www.medresman.org.cn) . Six months after the end of the trial, the clinical trial public management platform was adopted and opened to the public for inquiry.

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：

1.数据采集：使用纸质病历记录表（Case Record Form,CRF）收集患者数据。 2.数据管理：采集数据前对于填表人员统一进行培训，定期指定专人对已收集数据进行抽查。

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

1. Data collection: Patient data are collected using paper medical record form (CRF). 2. Data management: provide unified training for form-filling personnel before data collection, and regularly designate special personnel to conduct spot checks on the collected data.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2024-06-06 17:03:29