ChiCTR2300078099 版本V1.0 版本创建时间2023/11/28 17:19:52 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：

ChiCTR2300078099 

最近更新日期：

Date of Last Refreshed on：

2023-11-28 17:18:49 

注册时间：

Date of Registration：

2023-11-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

改良肝动脉灌注化疗（TOMOX-HAIC）联合信迪利单抗和贝伐珠单抗类似物用于晚期肝细胞癌一线治疗的有效性和安全性：前瞻性、单臂、II期临床研究

Public title：

Efficacy and safety of modified hepatic arterial infusion chemotherapy (TOMOX-HAIC) in combination with Sindelizumab and bevacizumab analogizes for first-line treatment of advanced hepatocellular carcinoma: a prospective, single-arm, Phase II clinical study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

改良肝动脉灌注化疗（TOMOX-HAIC）联合信迪利单抗和贝伐珠单抗类似物用于晚期肝细胞癌一线治疗的有效性和安全性：前瞻性、单臂、II期临床研究

Scientific title：

Efficacy and safety of modified hepatic arterial infusion chemotherapy (TOMOX-HAIC) in combination with Sindelizumab and bevacizumab analogizes for first-line treatment of advanced hepatocellular carcinoma: a prospective, single-arm, Phase II 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：

张永法 

研究负责人：

王鲁 

Applicant：

Yongfa Zhang 

Study leader：

LU WANG 

申请注册联系人电话：

Applicant telephone：

+86 21 6417 5590

研究负责人电话：

Study leader's telephone：

+86 21 6417 5590

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：

sysucczyf@163.com

研究负责人电子邮件：

Study leader's E-mail：

cms024mm@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：

上海市徐汇区东安路270号

研究负责人通讯地址：

上海市徐汇区东安路270号

Applicant address：

270 Dongan Road, Xuhui District, Shanghai

Study leader's address：

270 Dongan Road, Xuhui District, Shanghai

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：

复旦大学附属肿瘤医院

Applicant's institution：

Shanghai Cancer Center

研究负责人所在单位：

复旦大学附属肿瘤医院

Affiliation of the Leader：

Shanghai Cancer Center

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：

2310283-17

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：

复旦大学附属肿瘤医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee, Cancer Hospital Affiliated to Fudan University

伦理委员会批准日期：

Date of approved by ethic committee：

2023-11-07 00:00:00

伦理委员会联系人：

张玮静

Contact Name of the ethic committee：

weijingzhang

伦理委员会联系地址：

上海市徐汇区东安路270号

Contact Address of the ethic committee：

270 Dongan Road, Xuhui District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 6417 5590

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：

复旦大学附属肿瘤医院

Primary sponsor：

Shanghai Cancer Center

研究实施负责（组长）单位地址：

上海市徐汇区东安路270号

Primary sponsor's address：

270 Dongan Road, Xuhui District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

复旦大学附属肿瘤医院

具体地址：

上海市徐汇区东安路270号

Institution
hospital：

Shanghai Cancer Center

Address：

270 Dongan Road, Xuhui District, Shanghai

经费或物资来源：

无

Source(s) of funding：

none

Target disease：

HCC

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：

通过单臂、前瞻性、II期临床试验探索改良肝动脉灌注化疗联合信迪利单抗和贝伐珠单抗类似物用于晚期HCC患者的有效性和安全性。  

Objectives of Study：

To explore the efficacy and safety of modified hepatic arterial infusion chemotherapy combined with sindilizumab and bevacizumab analogues in patients with advanced HCC in a single-arm, prospective, phase II clinical trial.

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) 年龄在18岁至75岁之间的男性或未孕的女性； 2) 签署知情同意书； 3) 研究者认为患者有能力依从研究方案； 4) 经组织学或细胞学或临床诊断为肝细胞癌（HCC）； 5) 不适合进行根治手术治疗； 6) 既往未接受过系统抗肿瘤治疗 7) 至少有1 个可测量（依据RECIST 1.1标准可测量）、未经治疗的病灶； 8) 治疗前肿瘤组织样本（如可获得）。如果肿瘤组织可获得，则递交石蜡块中的1 个福尔马林固定、石蜡包埋（FFPE）肿瘤样本（首选），或含未染色、现切、系列切片的大约10-15 个载玻片，连同递交一份入组4 周内相关病理学报告。如果上文描述的FFPE 样本不可用，则也可接受任何类型的样本（包括细针抽吸活检样本、细胞团块样本[例如，源自胸膜积液的样本]和灌洗样本）。应随该样本提供一份相关病理学报告。如果肿瘤组织不可用（例如，因为既往诊断性测试而用尽），则患者仍旧有资格参与研究； 9) 入组前14天内的ECOG 体能状态评分为0 或1； 10) 入组前14天内Child-Pugh A 级或≤7的B级； 11) 血液学和脏器功能充足，基于入组之前14天内获得的以下实验室检查结果（除非另有说明）：绝对中性粒细胞计数(ANC)≥1.5×109/L（1500/μL），无粒细胞集落刺激因子支持；淋巴细胞计数≥0.5×109/L（500/μL）；血小板计数≥70×109/L（50, 000/μL）；血红蛋白≥85 g/L（8.5g/dL），为满足此条标准，可允许对患者输血；AST、ALT 和碱性磷酸酶（ALP）≤5倍正常值上限（ULN）；血清胆红素≤2倍正常值上限（ULN）；血清肌酐≤1.5倍正常值上限（ULN）或计算的肌酸酐清除率≥50 mL/min（使用Cockcroft-Gault 公式进行计算）；血清白蛋白≥28 g/L（2.8 g/dL）；未接受抗凝治疗的患者：INR 或APTT≤2倍正常值上限（ULN），或凝血酶原时间延长不超过3秒。尿纤维素试纸检查结果蛋白尿＜2＋（在开始研究治疗之前14天内进行）；基线纤维素试纸尿检结果为≥2＋蛋白尿的患者，应收集24小时尿液，然后必须证实24小时内尿蛋白含量＜1g。 12) 在入组研究之前任何急性、有临床意义的治疗相关毒性（既往治疗所致）均必须已缓解至≤1 级，脱发除外； 13) 筛选时HIV 抗体检测结果为阴性； 14) 有活动性乙肝病毒（HBV）感染的患者：在开始研究治疗之前28天内获得的HBVDNA＜2000IU/mL，且在入组研究之前至少接受7天抗HBV治疗（依据当地标准治疗进行治疗，例如恩替卡韦）且愿意在研究期间继续接受治疗；活动性丙肝病毒（HCV）感染的患者：在开始研究治疗之前28天内获得的HCVRNA＜2000IU/mL，且在入组研究之前至少接受7天抗HCV治疗且愿意在研究期间继续接受治疗； 15) 育龄妇女在开始治疗前必须进行阴性妊娠试验（βHCG），育龄妇女和男子（与育龄妇女发生性关系）必须同意在治疗期间和最后一次治疗剂量给药后6个月不间断地使用有效避孕措施。

Inclusion criteria

1) Men or infertile women between the ages of 18 and 75; 2) Signed informed consent; 3) Patients who, in the opinion of the investigator, are capable of complying with the study protocol; 4) a histological or cytological or clinical diagnosis of hepatocellular carcinoma (HCC); 5) Not suitable for radical surgical treatment; 6) no previous systemic antitumour therapy 7) at least 1 measurable (according to RECIST 1.1) untreated lesion; 8) pre-treatment tumour tissue sample (if available). If tumour tissue is available, submit 1 formalin-fixed, paraffin-embedded (FFPE) tumour sample in a paraffin block (preferred) or approximately 10-15 slides containing unstained, freshly cut, serial sections, together with a copy of the relevant pathology report within 4 weeks of enrolment. If the FFPE sample described above is not available, any type of sample (including fine-needle aspiration biopsy samples, cell mass samples [e.g., samples originating from pleural effusions], and lavage samples) may also be accepted. A copy of the relevant pathology report should be provided with this sample. If tumour tissue is unavailable (e.g., exhausted because of previous diagnostic testing), the patient remains eligible to participate in the study; 9) ECOG physical status score of 0 or 1 within 14 days prior to enrolment; 10) Child-Pugh grade A or ≤7 of B within 14 days prior to enrolment; 11) Adequate haematological and organ function, based on the following laboratory results obtained within 14 days prior to enrolment (unless otherwise stated): absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1500/μL) without granulocyte colony-stimulating factor support; lymphocyte count ≥ 0.5 x 109/L (500/μL); platelet count ≥ 70 x 109/L (50,000/μL); and platelet count ≥ 1.5 x 109/L (1,000/μL). L (50, 000/μL); haemoglobin ≥ 85 g/L (8.5 g/dL), for which transfusion to the patient may be permitted to meet this criterion; AST, ALT and alkaline phosphatase (ALP) ≤ 5 times the upper limit of normal (ULN); serum bilirubin ≤ 2 times the upper limit of normal (ULN); and serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or calculated creatinine clearance ≥50 mL/min (calculated using the Cockcroft-Gault formula); serum albumin ≥28 g/L (2.8 g/dL); in patients not receiving anticoagulation: INR or APTT ≤2 times the upper limit of normal (ULN) or prolongation of the prothrombin time by no more than 3 seconds. Urine fibre paper test result for proteinuria <2+ (performed within 14 days prior to initiation of study treatment); patients with a baseline fibre paper urine test result of ≥2+ proteinuria should have a 24-hour urine collection, which must then be confirmed to have a urine protein level of <1g over a 24-hour period. 12) Any acute, clinically significant treatment-related toxicity (from prior therapy) must have resolved to ≤ Grade 1 prior to study entry, with the exception of alopecia; 13) Negative HIV antibody test result at screening; 14) Patients with active hepatitis B virus (HBV) infection: HBVDNA <2000 IU/mL obtained within 28 days prior to initiation of study treatment and who have received at least 7 days of anti-HBV therapy (based on local standard of care, e.g., entecavir) prior to enrolment and are willing to continue treatment for the duration of the study; patients with active hepatitis C virus (HCV) infection. HCVRNA <2000 IU/mL obtained within 28 days prior to initiation of study treatment and who have received at least 7 days of anti-HCV treatment prior to enrolment in the study and are willing to continue treatment for the duration of the study; 15) Women of childbearing potential must have a negative pregnancy test (βHCG) prior to initiating treatment, and both women of childbearing potential and men (who are sexually active with women of childbearing potential) must agree to use effective contraception uninterruptedly for the duration of the treatment period and for 6 months after the administration of the last therapeutic dose.

排除标准：

1) 既往有其他恶性肿瘤病史； 2) 当前或既往自身免疫疾病或免疫缺陷，包括但不限于重症肌无力、肌炎、自身免疫性肝炎、系统性红斑狼疮、类风湿性关节炎、炎性肠病、抗磷脂抗体综合征、韦格纳肉芽肿、干燥综合征、格林-巴利综合征或多发性硬化，例外情况如下：曾患自身免疫相关甲状腺功能减退且接受甲状腺激素替代治疗的患者有资格参与研究；接受胰岛素治疗的经控制的1 型糖尿病患者有资格参与研究；仅有皮肤病学临床表现的湿疹、银屑病、慢性单纯性苔癣或白癜风患者（例如，不包括银屑病性关节炎患者），只要符合以下所有条件即有资格参与研究：1. 皮疹面积必须＜10%体表面积2. 基线时疾病控制情况良好，仅需要低效局部糖皮质激素治疗。3. 在过去12 个月内，原有状况未出现需要补骨脂素加A 波段紫外光辐射、甲氨蝶呤、维生素A 酸、生物制剂、口服钙调神经磷酸酶抑制剂或高效或口服糖皮质激素治疗的急性加重； 3) 特发性肺纤维化、机化性肺炎（例如，闭塞性细支气管炎）、药物性肺炎或特发性肺炎或在筛选期胸部计算机断层扫描（CT）图上可见活动性肺炎证据。允许辐射区（纤维化）曾有辐射性肺炎； 4) 已知活动性结核； 5) 在开始研究治疗之前3 个月内有重大心血管疾病（例如在开始研究治疗之前3 个月内有纽约心脏学会II 级或更严重心脏病、心肌梗死或脑血管意外）、不稳定型心律失常或不稳定型心绞痛； 6) 先天性长QT 综合征病史或筛查时校正的QT 间期>500ms（使用Fridericia 方法计算）； 7) 无法纠正的血清钾、钙或镁等电解质紊乱病史； 8) 在开始研究治疗之前4 周内接受过大手术治疗（诊断除外）或预期需在研究期间进行大手术治疗； 9) 曾在筛选之前 5 年内罹患除 HCC 之外的恶性肿瘤，转移或死亡风险（例如，5 年OS 率＞ 90%）可忽略不计的恶性肿瘤除外，例如经过充分治疗的原位宫颈癌、非黑素瘤皮肤癌、局限性前列腺癌、原位管癌或 I 期子宫癌； 10) 在开始研究治疗之前 4 周内有重度感染，包括但不限于因感染、菌血症或重度肺炎并发症而住院治疗； 11) 在开始研究治疗之前 2 周内口服或静脉给予治疗性抗生素。接受预防性抗生素（例如，预防尿路感染或慢性阻塞性肺病加重）的患者有资格参与研究； 12) 既往同种异基因干细胞或实体器官移植； 13) 在开始研究治疗之前 4 周内接受过减毒活疫苗治疗，或预期在信迪利单抗治疗期间或信迪利单抗末次给药后 5 个月内需接种此类疫苗； 14) 伴随出血或有高出血风险的未经治疗或未完全治疗的食管和/或胃静脉曲张患者。在入组之前，患者必须接受 B 超、CT、MRI 或肝弹性检测，评估所有静脉曲张的规模（小型至大型），并依据当地标准治疗进行治疗。在开始研究治疗之前 6 个月内接受过相应检查的患者无需再重复检查； 15) 同时感染 HBV 和 HCV。有 HCV 感染病史但 HCV RNA 的 PCR 结果为阴性的患者可认为未感染 HCV； 16) 症状性、未经治疗或逐渐进展的中枢神经系统（CNS）转移灶。只要符合以下所有标准，CNS 病灶经过治疗的无症状患者即有资格参与研究：在 CNS 之外必须有可依据 RECIST v1.1 测量的疾病；患者无颅内出血或脊髓内出血病史；转移灶仅限于小脑或幕上区（即，无中脑、脑桥、髓质或脊髓转移灶）；在完成 CNS 导向治疗后至开始研究治疗之间，无进展证据；患者在开始研究治疗之前 28 天内未接受过立体定向、全脑放疗和/或神经外科切除手术治疗；患者无持续使用糖皮质激素治疗CNS 疾病这一需求。允许使用剂量稳定的抗惊厥治疗。在筛选时新检出 CNS 转移灶的无症状患者，在接受放疗或手术治疗后有资格参与研究，且无需重复筛查脑扫描结果； 17) 患者不能接受随访或正参加其它可能干扰本研究结果的临床试验； 18) 研究者认为不适合入组本研究的受试者。

Exclusion criteria：

1) History of molluscum contagiosum; 2) Current or previous autoimmune disease or immunodeficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, desiccation syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions: patients with history of autoimmune-associated hypothyroidism and receiving thyroid hormone Patients with autoimmune-associated hypothyroidism on thyroid hormone replacement therapy are eligible; patients with controlled type 1 diabetes mellitus on insulin therapy are eligible; patients with eczema, psoriasis, chronic lichen simplex, or vitiligo (e.g., excluding patients with psoriatic arthritis) with dermatological manifestations only are eligible provided that all of the following conditions are met: 1. the area of the skin lesion must be less than 10 percent of the body surface area 2. the disease is well controlled at baseline and only needs to be treated by a physician. Disease is well controlled at baseline and requires only low potency topical glucocorticoid therapy 3) No acute exacerbation of a pre-existing condition within the last 12 months requiring treatment with psoralen plus A-band ultraviolet radiation, methotrexate, vitamin A acids, biologics, oral calmodulin nephosphatase inhibitors, or high potency or oral glucocorticoid therapy; 3) Idiopathic pulmonary fibrosis, organic pneumonia (e.g., occlusive bronchiectasis), drug-induced or idiopathic pneumonia, or evidence of active pneumonia visible on screening chest computed tomography (CT) maps. Allow for radiation areas (fibrosis) with previous radiation pneumonitis; 4) Known active tuberculosis; 5) significant cardiovascular disease (e.g., New York Heart Association Class II or worse heart disease, myocardial infarction, or cerebrovascular accident within 3 months prior to initiation of study treatment), unstable arrhythmia, or unstable angina pectoris within 3 months prior to initiation of study treatment; 6) history of congenital long QT syndrome or corrected QT interval >500ms at screening (calculated using the Fridericia method); 7) History of uncorrectable electrolyte disturbances such as serum potassium, calcium or magnesium; 8) Major surgical treatment (other than diagnostic) within 4 weeks prior to initiation of study treatment or anticipated need for major surgical treatment during the study period; 9) Previous malignancy other than HCC within 5 years prior to screening, except for malignancies with negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated in situ cervical cancer, non-melanoma skin cancer, limited prostate cancer, ductal carcinoma in situ, or stage I uterine cancer; 10) Severe infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalisation for complications of infection, bacteraemia or severe pneumonia; 11) Therapeutic antibiotics given orally or intravenously within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent urinary tract infections or exacerbations of COPD) are eligible for study participation; 12) Prior allogeneic stem cell or solid organ transplantation; 13) Received a live attenuated vaccine within 4 weeks prior to initiation of study treatment or are expected to require such a vaccine during treatment with sindilizumab or within 5 months of the last dose of sindilizumab; 14) Patients with untreated or incompletely treated oesophageal and/or gastric varices with concomitant bleeding or high risk of bleeding. Prior to enrolment, patients must undergo ultrasound, CT, MRI or hepatic elastography to assess the size of all varicose veins (small to large) and be treated according to local standard of care. Patients who have received the appropriate tests within 6 months prior to starting study treatment do not need to repeat the tests; 15) Co-infected with HBV and HCV Patients with a history of HCV infection but with negative PCR results for HCV RNA are considered to be free of HCV infection; 16) Symptomatic, untreated, or progressive central nervous system (CNS) metastases. Asymptomatic patients with treated CNS lesions will be eligible for the study as long as all of the following criteria are met: they must have disease outside of the CNS that is measurable according to RECIST v1.1; they do not have a history of intracranial haemorrhage or spinal haemorrhage; they have metastases limited to the cerebellar or supratentorial regions (i.e., no midbrain, pontine, medullary, or spinal metastases); there is no evidence of progression between the time of completion of CNS-guided therapy and the time of initiation of study treatment. No evidence of progression between completion of CNS-guided therapy and initiation of study treatment; Patients have not received stereotactic, whole-brain radiotherapy and/or neurosurgical resection within 28 days prior to initiation of study treatment; Patients do not have a need for ongoing glucocorticoid therapy for CNS disease. Dose-stable anticonvulsant therapy is allowed. Asymptomatic patients with newly detected CNS metastases at screening are eligible to participate in the study after radiotherapy or surgery and do not require repeat screening brain scans; 17) Patients are not eligible for follow-up or are participating in other clinical trials that may interfere with the results of this study; 18) Subjects who, in the opinion of the investigator, are not suitable for enrolment in this study.

研究实施时间：

Study execute time：

从 From 2023-11-14 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-11-30 00:00:00 至 To 2024-12-31 00:00:00  

干预措施：

Interventions：

组别：

改良HAIC联合信迪利单抗和贝伐珠单抗联合治疗组

样本量：

65

Group：

Modified HAIC combined with sindilizumab and bevacizumab analogue therapy

Sample size：

干预措施：

HAIC联合信迪利单抗和贝伐珠单抗类似物治疗

干预措施代码：

Intervention：

Modified HAIC combined with sindilizumab and bevacizumab analogue therapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China 

Province：

Shanghai 

City：

 

单位(医院)：

复旦大学附属肿瘤医院 

单位级别：

三甲 

Institution
hospital：

Shanghai Cancer Center

Level of the institution：

Tertiary

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 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：

不良事件发生率

指标类型：

次要指标

Outcome：

AE

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

总体生存期

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：

疾病控制率

指标类型：

次要指标

Outcome：

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：

疾病无进展生存期

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：

疾病进展时间

指标类型：

次要指标

Outcome：

Time to progression , TTP

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疾病缓解持续时间

指标类型：

次要指标

Outcome：

Duration of response, DOR

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：

肝组织

组织：

Sample Name：

liver tissue

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：

正在进行

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）：

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）：

医院数据库

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

Hospital database

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：

CRF

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：

  2023-11-28 17:18:49