ChiCTR2400093262 版本V1.0 版本创建时间2024/12/01 14:01:46 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：

 ChiCTR2400093262 

最近更新日期：

Date of Last Refreshed on：

 2024-12-01 14:00:38 

注册时间：

Date of Registration：

 2024-12-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

瑞维鲁胺联合雄激素剥夺治疗（ADT）联合或不联合多西他赛新辅助治疗寡转移前列腺癌的随机、平行队列、多中心临床研究

Public title：

A randomized, parallel-cohort, multicenter clinical study of Rezvilutamide in combination with androgen deprivation therapy (ADT) with or without docetaxel in the neoadjuvant treatment of oligometastatic prostate cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

瑞维鲁胺联合雄激素剥夺治疗（ADT）联合或不联合多西他赛新辅助治疗寡转移前列腺癌的随机、平行队列、多中心临床研究

Scientific title：

A randomized, parallel-cohort, multicenter clinical study of Rezvilutamide in combination with androgen deprivation therapy (ADT) with or without docetaxel in the neoadjuvant treatment of oligometastatic prostate 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：

林琦 

研究负责人：

陈伟 

Applicant：

Lin Qi 

Study leader：

Chen Wei 

申请注册联系人电话：

Applicant telephone：

 +86 152 0577 1010

研究负责人电话：

Study leader's
telephone：

+86 138 5777 1505

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：

 devillynch@126.com

研究负责人电子邮件：

Study leader's E-mail：

 2818777033@qq.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：

浙江省温州市瓯海区南白象街道上蔡村温州医科大学附属第一医院门诊2号楼4层a02诊室

研究负责人通讯地址：

浙江省温州市瓯海区南白象街道上蔡村温州医科大学附属第一医院门诊2号楼4层a02诊室

Applicant address：

a02 Room, 4th Floor, Building 2, the First Affiliated Hospital of Wenzhou Medical University, Shangcai Village, Nanbaixiang Street, Ouhai District, Wenzhou City, Zhejiang Province

Study leader's address：

a02 Room, 4th Floor, Building 2, the First Affiliated Hospital of Wenzhou Medical University, Shangcai Village, Nanbaixiang Street, Ouhai District, Wenzhou City, Zhejiang 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：

温州医科大学附属第一医院

Applicant's institution：

The First Affiliated Hospital of Wenzhou Medical University

研究负责人所在单位：

温州医科大学附属第一医院

Affiliation of the Leader：

The First Affiliated Hospital of Wenzhou Medical University

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：

 (2024)第(231)号

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：

温州医科大学附属第一医院临床研究伦理委员会

Name of the ethic committee：

Ethics Committee in Clinical Research of the First Affiliated Hospital of Wenzhou Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-10-12 00:00:00

伦理委员会联系人：

许慧清

Contact Name of the ethic committee：

Xu Huiqing

伦理委员会联系地址：

浙江省温州市瓯海区南白象温州医科大学附属第一医院新院区

Contact Address of the ethic committee：

New hospital of the First Affiliated Hospital of Wenzhou Medical University, South White Elephant, Ouhai District, Wenzhou City, Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 577 5557 8055

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 wyyyclinical@126.com

研究实施负责（组长）单位：

温州医科大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of Wenzhou Medical University

研究实施负责（组长）单位地址：

浙江省温州市瓯海区南白象温州医科大学附属第一医院新院区

Primary sponsor's address：

New hospital of the First Affiliated Hospital of Wenzhou Medical University, South White Elephant, Ouhai District, Wenzhou City, Zhejiang Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江省

市(区县)：

温州市

Country：

China

Province：

Zhejiang

City：

Wenzhou

单位(医院)：

温州医科大学附属第一医院

具体地址：

浙江省温州市瓯海区南白象温州医科大学附属第一医院新院区

Institution
hospital：

The First Affiliated Hospital of Wenzhou Medical University

Address：

New hospital of the First Affiliated Hospital of Wenzhou Medical University, South White Elephant, Ouhai District, Wenzhou City, Zhejiang Province

经费或物资来源：

国家卫生健康委医药卫生科技发展研究中心“创新药物上市后临床研究科研专项”

Source(s) of funding：

"Post-marketing clinical research projects of innovative drugs" of the Development Center for Medical Science & Technology National Health Commission of the People's Republic of China

研究疾病：

前列腺腺癌  

Target disease：

prostate cancer

研究疾病代码：

| - - - - - 2C82.0

Target disease code：

| - - - - - 2C82.0

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：

寡转移激素敏感性前列腺癌作为转移性前列腺癌的一个独特亚型，是一个重要的治疗窗口期，本研究探索瑞维鲁胺联合雄激素剥夺疗法联合或不联合多西他赛新辅助治疗寡转移激素敏感前列腺癌的疗效，通过合适的治疗干预，有望控制前列腺癌的进展，避免寡转移前列腺癌发展为广泛转移性前列腺癌。  

Objectives of Study：

Oligometastatic hormone-sensitive prostate cancer, as a distinct subtype of metastatic prostate cancer, represents an important therapeutic window. This study explores the efficacy of rezvilutamide in combination with androgen deprivation therapy, with or without docetaxel neoadjuvant treatment, for oligometastatic hormone-sensitive prostate cancer. Through appropriate therapeutic intervention, it is hoped that the progression of prostate cancer can be controlled, preventing oligometastatic prostate cancer from evolving into widespread metastatic prostate cancer.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1: 受试者自愿加入本研究，签署知情同意书，依从性好并愿意配合随访。 2: 年龄：≥18岁且<75岁（签署知情同意书时）。 3: 经组织学或细胞学确诊为前列腺腺癌。 4: 东部肿瘤协作组（ECOG）体能状态评分≤1级，预期寿命≥1年。 5: 随机化前1个月内临床和传统影像学检查（骨扫描、MRI/CT平扫等）证实的骨转移灶与淋巴结转移灶≤5个，且无内脏转移。 6: 重要的器官功能需符合如下： a、血红蛋白≥90g/L； b、ANC ≥ 1500/μL； c、血小板计数≥100 * 10^9/L； d、血钾≥3.5mmol/L； e、丙氨酸氨基转移酶（ALT）≤2.5×ULN；天门冬氨酸氨基转移酶（AST）≤2.5×ULN；尿素氮（BUN）（或尿素（UREA））和肌酐（Cr）≤1.5×ULN；左心室射血分数（LVEF）≥50%。 f、血清白蛋白≥30g/L。 7: 如配偶为育龄期妇女的受试者，同意在治疗期间及手术后4个月内采取有效的避孕措施。

Inclusion criteria

1: The participant is willing to join this study, has signed the informed consent form, is compliant and is willing to cooperate with follow-up. 2: age: >=18 years and <75 years when signing the informed consent. 3: Histologically or cytologically confirmed prostate adenocarcinoma. 4: Eastern Cooperative Oncology Group (ECOG) performance status <= 1, with an expected survival of >= 1 year. 5: Confirmed by conventional imaging (such as bone scans, MRI/CT) within one month before randomization, with ≤5 bone or lymph node metastases and no visceral metastasis. 6: Important organ functions must meet the following criteria: a. Hemoglobin >= 90 g/L; b. Absolute neutrophil count (ANC) >= 1500/μL; c. Platelet count >= 100 * 10^9/L; d. Serum potassium >= 3.5 mmol/L; e. Alanine aminotransferase (ALT) <= 2.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) <= 2.5 × ULN; blood urea nitrogen (BUN) (or urea) and creatinine (Cr) >= 1.5 × ULN; left ventricular ejection fraction (LVEF) >= 50%. f. Serum albumin >= 30 g/L. 7: If the participant's partner is a woman of childbearing potential, the participant agrees to use effective contraception during the treatment period and for 4 months after surgery.

排除标准：

1: 前列腺病理学结果为神经内分泌前列腺癌，包括小细胞癌。 2: 具有以下任何一项的患者不能入组本研究： a、既往接受过针对前列腺癌的 ADT、化疗、手术、放射线外照射、近距离照射、放射性药物或试验性局部治疗（如射频消融、冷冻、高能聚焦超声等），但以下情况允许入组：在本研究第一周期第一天（C1D1）之前，最长 3 个月的 ADT 治疗（药物或手术去势）伴有或不伴第一代抗雄激素药物（氟他胺、比卡鲁胺等）和/或瑞维鲁胺治疗（使用第一代抗雄激素药物的受试者，在研究治疗期须停用第一代抗雄激素药物），且在 C1D1 前没有影像学疾病进展证据（即达到 RECIST 1.1 标准的软组织疾病进展，和或≥2 个新发骨病灶（根据PCWG3 标准））或有临床意义的 PSA 升高（定义：在血清睾酮达到去势水平后，PSA 较最低水平升高≥50%）； b、既往使用过或计划在研究治疗期间使用第二代雄激素受体拮抗剂（如恩杂卢胺、阿帕他胺、达罗他胺、ARN-509、ODM-201等）、酮康唑、醋酸阿比特龙或其他抑制雄激素合成的在研药物（如 TAK-700）治疗前列腺癌； c、在 C1D1 前 4 周内，接受过以下治疗： ·α-还原酶抑制剂（如非那雄胺、度他雄胺等）； ·雌激素、孕酮类药物、雄激素、类固醇全身治疗（除外抗过敏目的的临时使用）； ·已知有抗前列腺癌或降低 PSA 水平作用的植物药（如锯棕榈） 3: 药物控制不佳的高血压（收缩压≥160mmg或舒张压≥95mmg）。 4: 活动期或有症状的病毒性肝炎或其它慢性肝脏疾病，已知的感染人免疫缺陷病毒（HIV）。 5: 有垂体或肾上腺功能障碍的病史。 6: 活动的自身免疫性疾病需使用激素治疗者。 7: 有临床意义的心脏病，包括：过去6个月内曾发生心肌梗死或动脉血栓；重度或不稳定型心绞痛；纽约心脏学会分级III或IV级心脏病；房颤或其他需要治疗的心律失常。 8: 首次使用化疗前3个月内参加过其他药物临床研究者。 9: 对紫杉类或多西他赛产生超敏反应的历史。 10: 需要伴随接受强CYP3A4抑制剂治疗的。 11: 在 C1D1 前 5 年内患有其他任何恶性肿瘤（已完全缓解的原位癌及研究者判定进展缓慢的恶性肿瘤除外）。 12: 根据研究者的判断，存在严重危害患者安全、可能混淆研究结果、或影响患者完成本研究的伴随疾病（如严重的糖尿病、神经或精神疾病等）或其他任何情况。

Exclusion criteria：

1: Pathological Diagnosis: Prostate pathology results indicate indicating neuroendocrine PCa, including small cell carcinoma. 2: Prior or Current Treatments: ·Patients who have previously received androgen deprivation therapy (ADT), chemotherapy, surgery, external beam radiation, brachytherapy, radiopharmaceuticals, or experimental local treatments (such as radiofrequency ablation, cryotherapy, high-intensity focused ultrasound, etc.) for PCa, except for the following: up to 3 months of ADT (medical or surgical castration) with or without first-generation anti-androgens (e.g., flutamide, bicalutamide, etc.) and/or rezvilutamide treatment before the first day of the first cycle (C1D1). Participants using first-generation anti-androgens must discontinue these medications during the study treatment period. Additionally, there should be no evidence of radiographic disease progression (i.e., soft tissue disease progression per RECIST 1.1 criteria, or >=2 new bone lesions per PCWG3 criteria) or clinically significant PSA rise (defined as a >=50% increase in PSA from the nadir after serum testosterone has reached castrate levels) before C1D1. ·Patients who have previously used or plan to use second-generation androgen receptor antagonists (e.g., enzalutamide, apalutamide, darolutamide, ARN-509, ODM-201, etc.), ketoconazole, abiraterone acetate, or other investigational drugs that inhibit androgen synthesis (e.g., TAK-700) for the treatment of PCa. ·Patients who have received any of the following treatments within 4 weeks before C1D1: a.5α-reductase inhibitors (e.g., finasteride, dutasteride, etc.). b.Estrogens, progestins, androgens, or systemic steroid therapy (except for short-term use for anti-allergic purposes). c.Herbal medicines known to have anti-prostate cancer effects or to lower PSA levels (e.g., saw palmetto). 3: Uncontrolled Hypertension: Uncontrolled hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 95 mmHg). 4: Hepatic Disorders: Active or symptomatic viral hepatitis or other chronic liver diseases , or known HIV infection. 5: Endocrine Disorders: History of pituitary or adrenal insufficiency. 6: Autoimmune Diseases: Active autoimmune diseases requiring hormone treatment. 7: Cardiac Conditions: Clinically significant heart disease, including: a. Myocardial infarction or arterial thrombosis within the past 6 months. b. Severe or unstable angina pectoris. c. New York Heart Association (NYHA) Class III or IV heart disease. d. Atrial fibrillation or other arrhythmias requiring treatment. 8: Recent Participation in Clinical Trials: Participation in another drug clinical trial within 3 months before the first dose of chemotherapy in this study. 9: Hypersensitivity: History of hypersensitivity to taxanes or docetaxel. 10: Concomitant Medications: Concomitant treatment with potent CYP3A4 inhibitors is needed. 11: Other Malignancies: History of any other malignancy within 5 years before C1D1, except for completely resolved in situ cancers and slowly progressing malignancies as determined by the investigator. 12: Other Conditions: Any other condition, as judged by the investigator, that may severely jeopardize the patient's safety, confuse the study results, or interfere with the patient's ability to complete the study (e.g., severe diabetes, neurological or psychiatric disorders, etc.).

研究实施时间：

Study execute time：

从 From 2024-11-01 00:00:00至 To 2027-11-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-11-30 00:00:00 至 To 2026-11-01 00:00:00

干预措施：

Interventions：

组别：

队列1

样本量：

 50

Group：

Queue 1

Sample size：

干预措施：

标准ADT（LHRH 激动剂或拮抗剂，或已接受睾丸切除术），每4周一个周期，共6个循环。如果选择通过药物进行ADT，则在每个周期开始的第一天服用。瑞维鲁胺240 mg，每日一次，口服，给药前 1 小时和给药后 2 小时禁食（有可能依据今后食物影响试验结果进行调整）。新辅助治疗后经过第二次PSMA-PET/CT评估，3个月内接受减瘤性前列腺癌性切除，术中要求进行盆腔淋巴结清扫至双侧髂总动脉水平。若术后病理提示存在切缘阳性或盆腔淋巴结转移，则可以在术后选择行盆腔辅助放疗。术后维持使用瑞维鲁胺治疗，直至疾病进展。

干预措施代码：

Intervention：

ADT (LHRH agonist or antagonist, or orchiectomy) is administered every 4 weeks for cycles. If ADT is administered via medication, it will be taken on the first day of each cycle. Rezvilutamide 240 mg is given once daily, orally, with fasting required 1 hour before and 2 hours after administration (this may be adjusted based on future food effect studies). After neoadjuvant treatment, PSMA-PET/CT will be performed to reconfirm metastatic lesions, and cRP will be performed within 3 months, with extended pelvic lymph node dissection up to the level of the bilateral common iliac arteries. If postoperative pathology indicates positive surgical margins or pelvic lymph node metastasis, adjuvant pelvic RT can be considered postoperatively. After surgery, combination ADT will be discontinued, and rezvilutamide monotherapy will be maintained until disease progression.

Intervention code：

组别：

队列2

样本量：

 50

Group：

Queue 2

Sample size：

干预措施：

标准ADT（LHRH 激动剂或拮抗剂，或已接受睾丸切除术）+多西他赛75mg/m2静脉滴注每3周一个周期，共6个循环。如果选择通过药物进行ADT，则在每个周期开始的第一天服用。多西他赛静脉滴注时间为每个周期开始的第一天。瑞维鲁胺240 mg，每日一次，口服，给药前 1 小时和给药后 2 小时禁食（有可能依据今后食物影响试验结果进行调整）。新辅助治疗后经过第二次PSMA-PET/CT评估，3个月内接受减瘤性前列腺癌切除，术中要求进行盆腔淋巴结清扫至双侧髂总动脉水平。若术后病理提示存在切缘阳性或盆腔淋巴结转移，则可以在术后选择行盆腔辅助放疗。术后维持使用瑞维鲁胺治疗，直至疾病进展。

干预措施代码：

Intervention：

ADT (LHRH agonist or antagonist, or orchiectomy) + docetaxel 75 mg/m2 intravenous infusion is administered every 3 weeks for 6 cycles. If ADT is administered via medication, it will be taken on the first day of each cycle. Docetaxel intravenous infusion is given on the first day of each cycle. Rezvilutamide 240 mg is given once daily, orally, with fasting required 1 hour before and 2 hours after administration (this may be adjusted based on future food effect studies). After neoadjuvant treatment, PSMA-PET/CT will be performed to reconfirm metastatic lesions, and cRP will be performed within 3 months, with extended pelvic lymph node dissection up to the level of the bilateral common iliac arteries. If postoperative pathology indicates positive surgical margins or pelvic lymph node metastasis, adjuvant pelvic RT can be considered postoperatively. After surgery, combination ADT will be discontinued, and rezvilutamide monotherapy will be maintained until disease progression.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

 温州市 

Country：

China

Province：

Zhejiang

City：

Wenzhou

单位(医院)：

 温州医科大学附属第一医院 

单位级别：

 三甲 

Institution
hospital：

The First Affiliated Hospital of Wenzhou Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

 温州市 

Country：

China

Province：

Zhejiang

City：

Wenzhou

单位(医院)：

 温州医科大学附属第二医院 

单位级别：

 三甲 

Institution
hospital：

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

完全病理缓解

指标类型：

主要指标

Outcome：

pathologic complete response

Type：

Primary indicator

测量时间点：

减瘤性前列腺癌切除术后

测量方法：

病理学评估

Measure time point of outcome：

After cytoreductive prostatectomy

Measure method：

Pathological evaluation

指标中文名：

到ECOG评分显示受试者体力状况恶化的时间，开始用药至评分较基线上升的间隔

指标类型：

次要指标

Outcome：

Time to deterioration in ECOG performance status, defined as the interval from the start of treatment to an increase in the ECOG score from baseline

Type：

Secondary indicator

测量时间点：

术后4周、术后8周、术后12周、术后半年、半年之后每三个月

测量方法：

ECOG评分

Measure time point of outcome：

4 weeks after surgery, 8 weeks after surgery, 12 weeks after surgery, half a year after surgery, and every three months after half a year

Measure method：

Eastern Cooperative Oncology Group Performance Status

指标中文名：

减瘤性前列腺癌切除术前影像学提示相较新辅助治疗开始前前列腺体积减小30%的比例

指标类型：

次要指标

Outcome：

The proportion of patients with a ≥30% reduction in prostate volume on imaging before cytoreductive surgery compared to pre-neoadjuvant therapy

Type：

Secondary indicator

测量时间点：

接受减瘤性前列腺癌切除术前

测量方法：

影像学检查

Measure time point of outcome：

Before undergoing cytoreductive prostatectomy

Measure method：

Imaging examinations

指标中文名：

微小残留病变

指标类型：

次要指标

Outcome：

Minimal residual disease

Type：

Secondary indicator

测量时间点：

减瘤性前列腺癌切除术后

测量方法：

病理学评估

Measure time point of outcome：

After cytoreductive prostatectomy

Measure method：

Pathological evaluation

指标中文名：

主要病理缓解

指标类型：

次要指标

Outcome：

Major pathological response

Type：

Secondary indicator

测量时间点：

减瘤性前列腺癌切除术后

测量方法：

病理学评估

Measure time point of outcome：

After cytoreductive prostatectomy

Measure method：

Pathological evaluation

指标中文名：

一年生化无进展生存率

指标类型：

次要指标

Outcome：

One-year biochemical progression-free survival

Type：

Secondary indicator

测量时间点：

术后4周、术后8周、术后12周、术后半年、半年之后每三个月

测量方法：

实验室检查

Measure time point of outcome：

4 weeks after surgery, 8 weeks after surgery, 12 weeks after surgery, half a year after surgery, and every three months after half a year

Measure method：

laboratory examinations

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：

术后4周、术后8周、术后12周、术后半年、半年之后每三个月

测量方法：

通过随访进行记录和跟踪

Measure time point of outcome：

4 weeks after surgery, 8 weeks after surgery, 12 weeks after surgery, half a year after surgery, and every three months after half a year

Measure method：

Documentation and follow-up are performed through follow-up visits

指标中文名：

无影像学进展生存期

指标类型：

次要指标

Outcome：

Radiographic progression-free survival

Type：

Secondary indicator

测量时间点：

每12周进行全身影像学评估

测量方法：

影像学检查

Measure time point of outcome：

every 12 weeks

Measure method：

Imaging examinations

指标中文名：

至PSA进展时间

指标类型：

次要指标

Outcome：

Time to PSA progression

Type：

Secondary indicator

测量时间点：

术后4周、术后8周、术后12周、术后半年、半年之后每三个月

测量方法：

实验室检查

Measure time point of outcome：

4 weeks after surgery, 8 weeks after surgery, 12 weeks after surgery, half a year after surgery, and every three months after half a year

Measure method：

laboratory examinations

指标中文名：

通过生活质量评估量表（FACT-P）对受试者生活质量总分和各分量进行评分，出现症状学进展

指标类型：

次要指标

Outcome：

Quality of life assessment using the Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire, including total and subscale scores, and the occurrence of symptomatic progression

Type：

Secondary indicator

测量时间点：

术后4周、术后8周、术后12周、术后半年、半年之后每三个月

测量方法：

生活质量评估量表（FACT-P）

Measure time point of outcome：

4 weeks after surgery, 8 weeks after surgery, 12 weeks after surgery, half a year after surgery, and every three months after half a year

Measure method：

Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

仅病理读片 不采集

组织：

无

Sample Name：

no

Tissue：

no

人体标本去向

 其它  

说明

无

Fate of sample：

0thers  

Note：

no

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 75 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

由非直接接触患者的主治医师通过随机化R语言程序包生成随机数列

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

Random number sequences are generated by the attending physician, who does not have direct contact with the patients, using R language randomization packages.

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：

无

Blinding：

None

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）：

不共享

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

No share

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：

CRF

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：

  2024-12-01 14:00:38