ChiCTR2400088240 版本V1.0 版本创建时间2024/08/14 09:59:06 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：

 ChiCTR2400088240 

最近更新日期：

Date of Last Refreshed on：

 2024-08-14 09:59:01 

注册时间：

Date of Registration：

 2024-08-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评价伊立替康脂质体（Ⅱ）或伊立替康联合 5-氟尿嘧 啶、亚叶酸钙、贝伐珠单抗用于既往一线标准治疗失败 的转移性结直肠癌（mCRC）： 一项随机化、开放标签、多中心临床研究

Public title：

Evaluation of irinotecan liposomes (II) or irinotecan combined with 5-fluurazil Ridine, calcium folinate, and bevacizumab have failed in previous first-line standard therapy Metastatic colorectal Cancer (mCRC) : A randomized, open-label, multicenter clinical study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价伊立替康脂质体（Ⅱ）或伊立替康联合 5-氟尿嘧 啶、亚叶酸钙、贝伐珠单抗用于既往一线标准治疗失败 的转移性结直肠癌（mCRC）： 一项随机化、开放标签、多中心临床研究

Scientific title：

Evaluation of irinotecan liposomes (II) or irinotecan combined with 5-fluurazil Ridine, calcium folinate, and bevacizumab have failed in previous first-line standard therapy Metastatic colorectal Cancer (mCRC) : A randomized, open-label, multicenter clinical study

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：

陈敏斌 

研究负责人：

陈敏斌 

Applicant：

Chen Minbin 

Study leader：

Chen Minbin 

申请注册联系人电话：

Applicant telephone：

 +86 137 3266 6081

研究负责人电话：

Study leader's
telephone：

+86 137 3266 6081

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：

 xuxiaowei0710@126.com

研究负责人电子邮件：

Study leader's E-mail：

 xuxiaowei0710@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：

昆山市前进东路566号

研究负责人通讯地址：

昆山市前进东路566号

Applicant address：

No. 566 East Qianjin Road, Kunshan City

Study leader's address：

No. 566 East Qianjin Road, Kunshan City

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：

昆山市第一人民医院

Applicant's institution：

Kunshan First People's Hospital

研究负责人所在单位：

昆山市第一人民医院

Affiliation of the Leader：

Kunshan First People's 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：

 2024-01-020-H01

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：

昆山市第一人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of Kunshan First People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-05-16 00:00:00

伦理委员会联系人：

张露远

Contact Name of the ethic committee：

Zhang Luyuan

伦理委员会联系地址：

昆山市第一人民医院科研楼309室

Contact Address of the ethic committee：

Room 309, Scientific Research Building, Kunshan First People's Hospital

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 151 6230 3710

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：

昆山市第一人民医院

Primary sponsor：

Kunshan First People's Hospital

研究实施负责（组长）单位地址：

昆山市前进东路566号

Primary sponsor's address：

No. 566 East Qianjin Road, Kunshan City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

苏州市

Country：

China

Province：

Jiangsu Province

City：

Suzhou City

单位(医院)：

昆山市第一人民医院

具体地址：

昆山市前进东路566号

Institution
hospital：

Kunshan First People's Hospital

Address：

No. 566 East Qianjin Road, Kunshan City

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

转移性结直肠癌  

Target disease：

metastatic colorectal 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：

随机平行对照 

Study design：

Parallel 

研究目的：

主要研究目的 ? 客观缓解率（ORR） 次要研究目的 ? 总生存期（OS）、无进展生存期（PFS）和疾病控制率（DCR） ? 安全性  

Objectives of Study：

Main research purpose Objective response rate (ORR) Secondary research purpose Overall survival (OS), progression-free survival (PFS), and disease control rate (DCR) Safety

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. 年龄≥18 岁且≤75 岁，性别不限； 2. 经病理组织学和/或细胞学诊断结肠或直肠癌，临床记录显示为不可手术切除的晚期转移性结肠癌或直肠癌（即，根据 UICC/AJCC TNM 分期系统[2017 年第 8 版]分为 IV 期）； 3. 根据 RECIST v1.1 标准，至少具有 1 个可测量靶病灶（即，非淋巴结病灶 CT 扫描长径≥10 mm，淋巴结病灶 CT 扫描短径≥15 mm）； 4. 既往接受过针对转移性疾病的奥沙利铂±VEGF/EGFR一线标准治疗且治疗失败或不耐受； 5. 美国东部肿瘤协作组（ECOG） 体力状态评分 0-1； 6. 预期生存时间≥3 个月； 7. 无主要器官的功能障碍，即随机化前 14 天内受试者的器官功能水平及相关实验室指标必须符合下列要求： (1) 血常规（开始研究治疗前 14 天内未进行过输血、输血小板、生长因子等支持治疗）：白细胞（WBC）≥3.0×109/L；中性粒细胞绝对计数（ANC）≥1.5×109/L；血小板计数（PLT）≥100×109/L；血红蛋白（Hb）≥90 g/L (2) 血生化：血清白蛋白（ALB）≥30 g/L；谷丙转氨酶（ALT） /谷草转氨酶（AST）≤2.5 倍正常值上限（ULN），如有肝转移则 ALT/AST≤5×ULN；总胆红素（TBIL） ≤1.5×ULN；血清肌酐（Cr） ≤1.5×ULN，或根据 Cockcroft-Gault 公式计算的内生肌酐清除率≥60 mL/min (3) 尿常规：尿常规提示尿蛋白<++；若基线时尿蛋白≥++ ，需证实 24 小时尿蛋白定量≤1.0g。 (4) 凝血功能（开始研究治疗前 14 天内）：凝血酶原时间（PT）或活化部分凝血活酶时间（aPTT）≤1.5×ULN、国际标准化比值（INR）≤1.5 ×ULN（未接受过抗凝治疗）；若受试者应用使用稳定剂量的抗凝剂或维生素 K 拮抗剂（如华法林、肝素或其类似物治疗），在凝血酶原时间国际标准化比值（INR）≤ 1.5 的前提下，允许以预防目的使用小剂量华法林（1 mg 口服，每日一次）或小剂量阿司匹林（每日用量不超过 100mg）； (5) 心脏功能：12-导联心电图正常或经研究者判断无临床意义的 12-导联心电图异常（即，男性 QTcF＜450 ms，女性 QTcF＜470 ms）；左室射血分数（LVEF）≥正常值低限（即，LVEF≥50%）； 8. 既往接受的其他抗肿瘤治疗需结束治疗 4 周及以上，且一般的身体状况或相关的不良反应已恢复（毒性反应≤1 级）或达到稳定状态； 9. 随机化前 7 天内育龄妇女血清妊娠试验必须为阴性，且必须为非哺乳期；育龄期女性受试者或伴侣为育龄期女性的男性受试者必须同意在试验期间和研究治疗期结束后 6 个月内采取医学许可的避孕措施（例如，宫内节育器、男性手术绝育、避孕药或避孕套）； 10. 自愿参加并签署知情同意书； 11. 能依从研究访视计划和其它方案要求。

Inclusion criteria

1. Age ≥ 18 years old and ≤ 75 years old, gender not limited; 2. Diagnosed with colon or rectal cancer through histopathology and/or cytology, clinical records show advanced metastatic colon or rectal cancer that cannot be surgically removed (i.e., classified as stage IV according to the UICC/AJCC TNM staging system [8th edition, 2017]); 3. According to the RECIST v1.1 standard, there must be at least one measurable target lesion (i.e., non lymph node lesions with a CT scan length of ≥ 10 mm and lymph node lesions with a CT scan length of ≥ 15 mm); 4. Previously received first-line standard treatment with oxaliplatin ± VEGF/EGFR for metastatic diseases and treatment failure or intolerance; 5. ECOG (Eastern Cooperative Oncology Group) physical status score 0-1; 6. Expected survival time ≥ 3 months; 7. There must be no major organ dysfunction, meaning that the organ function level and relevant laboratory indicators of the subjects within 14 days before randomization must meet the following requirements: (1) Blood routine (no supportive treatment such as blood transfusion, platelet transfusion, growth factor, etc. within 14 days before starting the study treatment): White blood cell (WBC) ≥ 3.0 × 109/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet count (PLT) ≥ 100 × 109/L; Hemoglobin (Hb) ≥ 90 g/L (2) Blood biochemistry: serum albumin (ALB) ≥ 30 g/L; ALT/AST ≤ 2.5 times the upper limit of normal (ULN), and ALT/AST ≤ 5 times ULN if there is liver metastasis; Total bilirubin (TBIL) ≤ 1.5 × ULN; Serum creatinine (Cr) ≤ 1.5 × ULN, or endogenous creatinine clearance rate calculated according to Cockcroft Gault formula ≥ 60 mL/min (3) Urine routine: Urine routine indicates urinary protein<++; If the baseline urinary protein is ≥++, it needs to be confirmed that the 24-hour urinary protein quantification is ≤ 1.0g. (4) Coagulation function (within 14 days before starting study treatment): Prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, international normalized ratio (INR) ≤ 1.5 × ULN (not receiving anticoagulant therapy); If the subject is treated with stable doses of anticoagulants or vitamin K antagonists (such as warfarin, heparin, or their analogues), and the international normalized ratio (INR) of prothrombin time is ≤ 1.5, it is allowed to use low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (daily dose not exceeding 100mg) for preventive purposes; (5) Cardiac function: Normal 12 lead electrocardiogram or abnormal 12 lead electrocardiogram judged by researchers to have no clinical significance (i.e. male QTcF<450 ms, female QTcF<470 ms); Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (i.e. LVEF ≥ 50%); 8. Other anti-tumor treatments received in the past must have ended treatment for 4 weeks or more, and the general physical condition or related adverse reactions have been restored (toxicity ≤ grade 1) or reached a stable state; 9. Within 7 days before randomization, the serum pregnancy test of women of childbearing age must be negative and they must be non lactating; Female participants of childbearing age or male participants with partners of childbearing age must agree to use medically licensed contraceptive measures (such as intrauterine devices, male surgical sterilization, birth control pills, or condoms) during the trial period and within 6 months after the end of the study treatment period; 10. Voluntarily participate and sign an informed consent form; 11. Able to comply with research visit plans and other protocol requirements.

排除标准：

1. 在筛选前 5 年内曾患有结直肠癌以外的恶性肿瘤（已治愈的皮肤基底细胞或鳞状上皮细胞癌、宫颈原位癌、研究者评估具有低风险转移和死亡风险的恶性肿瘤除外）； 2. 已知经肿瘤组织经免疫组化方法证实为错配修复缺陷（dMMR）状态，或二代测序（NGS）/聚合酶链式反应（PCR）方法确认为微卫星高不稳定性（MSI-H）状态，且经研究者评估适合接受免疫检查点抑制剂（PD-1/PD-L1 抑制剂）治疗； 3. 二代测序（NGS）/聚合酶链式反应（PCR）方法确认为 BRAF V600E 突变，对化疗预后不良的患者； 4. 已知有中枢神经系统转移者，对于临床疑似中枢神经系统转移的患者，开始研究治疗前 28 天内必须进行增强电子计算机断层扫描（CT）或增强核磁共振（MRI）检查，排除中枢神经系统转移； 5. 既往接受过伊立替康/伊立替康脂质体为基础的化疗； 6. 开始研究药物前 14 天内使用 CYP3A4、CYP2C8 和 UGT1A1 强抑制剂/强诱导剂； 7. 随机化前 4 周内参加过其他药物临床试验； 8. 临床记录显示有严重的胃肠功能紊乱（包括出血、梗阻；NCI-CTCAE v5.0＞2 级的炎症；NCI-CTCAE v5.0＞1 级的腹泻）； 9. 存在妨碍试验药物治疗的严重合并症、活动性感染或未控制的糖尿病： (1) 研究者认为会影响受试者接受研究方案治疗能力的未受控制的严重医学疾病，例如合并严重的内科疾病，包括严重心脏病、脑血管病、未控制的糖尿病、未控制的高血压、不受控制的感染、活动性消化性溃疡等； (2) 筛选前一年内发生过动/静脉血栓事件，如脑血管意外（包括暂时性缺血性发作）、深静脉血栓（因前期化疗行静脉置管引发静脉血栓经研究者判断已痊愈者除外）及肺栓塞等； (3) 影像学显示肿瘤已侵犯重要血管周围或经研究者判断患者肿瘤在治疗期间有极高可能侵袭重要血管而引起致命大出血的情况； (4) 受试者患有活动性、已知或疑似患有自身免疫性疾病，包括系统性红斑狼疮、桥本氏甲状腺炎、硬皮病、结节性多动脉炎或自身免疫性肝炎；允许患有 I 型糖尿病、仅需要激素替代的甲状腺功能减退症、不需要全身治疗的皮肤病（如白斑、牛皮癣或脱发）或在没有外部诱因触发的情况下预计不会复发的病症的受试者参加； (5) 有活动性肺结核感染。在用药前1年内有活动性肺结核感染的患者，即使已经治疗，也要排除；超过1 年以前有活动性肺结核感染病史的患者也要排除，除非证明以前接受过规范的抗结核治疗； (6) 既往有间质性肺病，或有（非感染性）肺炎且需要口服或静脉类固醇激素治疗； (7) 需要长期接受全身性激素（剂量相当于＞10mg 强的松/天）或者其他任何形式的免疫抑制治疗。使用吸入性或外用皮质类固醇的受试者可以入选； (8) 有未能良好控制的心脏临床症状或疾病，如：纽约心脏病协会（NYHA） 2 级以上心力衰竭；不稳定型心绞痛；6 个月内发生过心肌梗死；有临床意义、需要治疗或干预的室上性或室性心律失常； (9) 丙型肝炎病毒（HCV）抗体阳性或人免疫缺陷病毒（HIV）抗体阳性； (10) 筛选前 4 周内发生过严重感染（NCI-CTCAE v5.0＞2 级），如需要住院治疗的严重肺炎、菌血症、感染并发症等；开始研究治疗前2周内存在感染的症状和体征需要静脉使用抗生素治疗（预防性使用抗生素的情况除外）； (11) 根据 NCI-CTCAE v5.0 患有≥ 2 级外周神经病变的受试者。 10. 已知对任意试验药物（盐酸伊立替康脂质体注射液（Ⅱ）、伊立替康、5-FU/LV、贝伐珠单抗）或其辅料过敏或不能耐受； 11. 已知存在任意试验药物（盐酸伊立替康脂质体注射液（Ⅱ）、伊立替康、5-FU/LV、贝伐珠单抗）禁忌症； 12. 怀孕、哺乳期、已生育但拒绝采取避孕措施的妇女； 13. 研究者认为应排除在本研究之外，例如经研究者判断，受试者有其他可能导致本研究被迫中途终止的因素，如存在其他的严重疾病（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的。

Exclusion criteria：

1. Have had malignant tumors other than colorectal cancer within the past 5 years prior to screening (excluding cured skin basal cell or squamous cell carcinoma, cervical carcinoma in situ, and malignant tumors assessed by researchers as having low risk of metastasis and death); 2. It is known that the tumor tissue has been confirmed by immunohistochemistry to have mismatch repair deficiency (dMMR) status, or by second-generation sequencing (NGS)/polymerase chain reaction (PCR) methods to have microsatellite high instability (MSI-H) status, and has been evaluated by researchers to be suitable for treatment with immune checkpoint inhibitors (PD-1/PD-L1 inhibitors); 3. Second generation sequencing (NGS)/polymerase chain reaction (PCR) methods confirmed BRAF V600E mutation in patients with poor chemotherapy prognosis; 4. For patients with suspected central nervous system metastases, enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI) must be performed within 28 days before starting treatment to rule out central nervous system metastases; 5. Previously received chemotherapy based on irinotecan/irinotecan liposomes; 6. Use strong inhibitors/inducers of CYP3A4, CYP2C8, and UGT1A1 within 14 days before starting the drug study; 7. Participated in clinical trials of other drugs within 4 weeks prior to randomization; 8. Clinical records show severe gastrointestinal dysfunction (including bleeding, obstruction; NCI-CTCAE v5.0>grade 2 inflammation; Diarrhea with NCI-CTCAE v5.0>grade 1); 9. There are serious complications, active infections or uncontrolled diabetes that hinder the treatment of the investigational drug: (1) Uncontrolled serious medical diseases that the researchers think will affect the ability of the subjects to receive the treatment of the research scheme, such as serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc; (2) Screening for arterial/venous thrombotic events that occurred within the previous year, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis (excluding those caused by venous catheterization during previous chemotherapy and judged to have recovered by researchers), and pulmonary embolism; (3) Imaging shows that the tumor has invaded important blood vessels or the researchers have determined that the patient's tumor has a high possibility of invading important blood vessels and causing fatal massive bleeding during treatment; (4) The subject has active, known or suspected autoimmune diseases, including systemic lupus erythematosus, Hashimoto's thyroiditis, scleroderma, nodular polyarteritis or autoimmune hepatitis; Subjects suffering from type I diabetes, hypothyroidism only requiring hormone replacement, skin diseases not requiring systemic treatment (such as leukoplakia, psoriasis or alopecia), or diseases that are not expected to recur without external triggers are allowed to participate; (5) There is active tuberculosis infection. Patients with active pulmonary tuberculosis infection within the year prior to medication should be excluded, even if they have already been treated; Patients with a history of active pulmonary tuberculosis infection more than 1 year ago should also be excluded, unless it is proven that they have received standardized anti tuberculosis treatment in the past; (6) Previous interstitial lung disease or non infectious pneumonia requiring oral or intravenous steroid hormone therapy; (7) Long term systemic hormone therapy (equivalent to>10mg prednisone/day) or any other form of immunosuppressive therapy is required. Subjects using inhaled or topical corticosteroids may be included; (8) Clinical symptoms or diseases of the heart that have not been well controlled, such as NYHA grade 2 or above heart failure; Unstable angina pectoris; Have experienced myocardial infarction within 6 months; Supraventricular or ventricular arrhythmias that have clinical significance and require treatment or intervention; (9) Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive; (10) Serious infections (NCI-CTCAE v5.0>grade 2) occurred within the first 4 weeks of screening, such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc; Symptoms and signs of infection within 2 weeks prior to starting treatment require intravenous antibiotic therapy (excluding prophylactic use of antibiotics); (11) According to NCI-CTCAE v5.0, subjects with grade ≥ 2 peripheral neuropathy. 10. Known to be allergic or intolerant to any test drug (irinotecan hydrochloride liposome injection (II), irinotecan, 5-FU/LV, bevacizumab) or its excipients; 11. It is known that there are contraindications for any experimental drug (irinotecan hydrochloride liposome injection (II), irinotecan, 5-FU/LV, bevacizumab); 12. Women who are pregnant, breastfeeding, or have given birth but refuse to take contraceptive measures; 13. The researchers believe that the subjects should be excluded from this study, for example, if the researchers determine that there are other factors that may cause the study to be terminated midway, such as the presence of other serious illnesses (including mental illnesses) that require concomitant treatment, serious laboratory test abnormalities, accompanied by family or social factors, which may affect the safety of the subjects or the collection of data and samples.

研究实施时间：

Study execute time：

从 From 2024-08-20 00:00:00至 To 2026-02-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-08-20 00:00:00 至 To 2025-06-30 00:00:00

干预措施：

Interventions：

组别：

nal-IRI+5-FU/LV+贝伐珠单抗组

样本量：

 54

Group：

nal-IRI+5-FU/LV+ bevacizumab group

Sample size：

干预措施：

伊立替康脂质体（II）联合5-FU/LV、贝伐珠单抗

干预措施代码：

Intervention：

Irinotecan liposomes (II) combined with 5-FU/LV and bevacizumab

Intervention code：

组别：

FOLFIRI+贝伐珠单抗

样本量：

 54

Group：

FOLFIRI+ Bevacizumab

Sample size：

干预措施：

伊立替康联合5-FU/LV、贝伐珠单抗

干预措施代码：

Intervention：

Irinotecan in combination with 5-FU/LV and bevacizumab

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏省 

市(区县)：

  

Country：

China

Province：

Jiangsu Province

City：

单位(医院)：

 常熟市第一人民医院 

单位级别：

 三级 

Institution
hospital：

Changshu First People's Hospital

Level of the institution：

Tertiary

国家：

 中国

省(直辖市)：

 江苏省 

市(区县)：

  

Country：

China

Province：

Jiangsu Province

City：

单位(医院)：

 昆山市第一人民医院 

单位级别：

 三甲 

Institution
hospital：

Kunshan First People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

客观缓解率

指标类型：

主要指标

Outcome：

objective remission 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：

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：

无进展生存期

指标类型：

次要指标

Outcome：

progression free 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：

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：

安全性

指标类型：

次要指标

Outcome：

security

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：

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）：

随机数字表

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

Random number table

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：

无

Blinding：

None

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）：

不共享原始数据

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

Raw data is not shared

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：

电子采集和管理系统

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

EDC

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：

  2024-08-14 09:59:01