中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2400083915
最近更新日期： Date of Last Refreshed on：	2024-05-07 15:07:19
注册时间： Date of Registration：	2024-05-07 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	一项在晚期实体瘤受试者中评估YSCH-01瘤内注射液的安全性/耐受性和初步疗效的开放、单/多次给药剂量递增及剂量扩展临床研究
Public title：	An open, single/multiple dose escalation and dose extension clinical study evaluating the safety/tolerability and initial efficacy of YSCH-01 intratumoral injection in subjects with advanced solid tumors
注册题目简写：
English Acronym：
研究课题的正式科学名称：	一项在晚期实体瘤受试者中评估YSCH-01瘤内注射液的安全性/耐受性和初步疗效的开放、单/多次给药剂量递增及剂量扩展临床研究
Scientific title：	An open, single/multiple dose escalation and dose extension clinical study evaluating the safety/tolerability and initial efficacy of YSCH-01 intratumoral injection in subjects with advanced solid tumors
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：	钟雯婷	研究负责人：	邢力刚
Applicant：	Wenting Zhong	Study leader：	Yanqiu Liu
申请注册联系人电话： Applicant telephone：	+86 130 5228 6715	研究负责人电话： Study leader's telephone：	+86 531 6762 6819
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：	zhongwenting@yuansongbio.com	研究负责人电子邮件： Study leader's E-mail：	xinglg@medmail.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：	上海市奉贤区沪杭公路1588号	研究负责人通讯地址：	山东省济南市槐荫区济兖路440号
Applicant address：	1588 Huhang Road, Fengxian District, Shanghai	Study leader's address：	No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong 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：	上海元宋生物技术有限公司
Applicant's institution：	Shanghai Yuansong Biotechnology Co., LTD.
研究负责人所在单位：	山东第一医科大学附属肿瘤医院
Affiliation of the Leader：	Affiliated Cancer Hospital of Shandong First 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：	SDZLEC2024-070-02	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：	山东第一医科大学附属肿瘤医院伦理委员会
Name of the ethic committee：	Ethics Committee of Affiliated Cancer Hospital of Shandong First Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2024-04-12 00:00:00
伦理委员会联系人：	李朝伟
Contact Name of the ethic committee：	Chaowei Li
伦理委员会联系地址：	山东省济南市槐荫区济兖路440号山东省肿瘤医院（250117）
Contact Address of the ethic committee：	No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong Province.Affiliated Cancer Hospital of Shandong First Medical University(250117)
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 531 6762 6929	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：

山东第一医科大学附属肿瘤医院

Primary sponsor：

Affiliated Cancer Hospital of Shandong First Medical University

研究实施负责（组长）单位地址：

山东省济南市槐荫区济兖路440号

Primary sponsor's address：

No. 440, Jiyan Road, Huaiyin District, Jinan City, Shandong 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)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海元宋生物技术有限公司	具体地址：	上海市奉贤区沪杭公路1588号
Institution hospital：	Shanghai Yuansong Biotechnology Co., LTD.	Address：	1588 Huhang Road, Fengxian District, Shanghai

经费或物资来源：

上海元宋生物技术有限公司

Source(s) of funding：

Shanghai Yuansong Biotechnology Co., LTD.

研究疾病：

实体瘤

Target disease：

solid tumor

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：

I期临床试验

Study phase：

1

研究设计：

横断面

Study design：

Cross-sectional

研究目的：

1.主要目的：评价YSCH-01用于治疗复发/难治性晚期实体瘤受试者的安全性/耐受性。确定YSCH-01临床推荐剂量。 2.次要目的：评价YSCH-01治疗复发/难治性晚期实体瘤的初步疗效。评估YSCH-01的生物分布和病毒脱落情况。评价接受YSCH-01受试者体内的药效学（PD）。评价接受YSCH-01受试者体内的免疫原性。初步评估YSCH-01对复发/难治性晚期实体瘤受试者生活质量的影响。

Objectives of Study：

1.Objective: To evaluate the safety/tolerability of YSCH-01 in patients with relapsed/refractory advanced solid tumors. To determine the recommended clinical dose of YSCH-01. 2.Secondary objective: To evaluate the initial efficacy of YSCH-01 in the treatment of relapsed/refractory advanced solid tumors. To evaluate the biological distribution and viral shedding of YSCH-01. To evaluate pharmacodynamics (PD) in vivo in subjects receiving YSCH-01. To evaluate immunogenicity in subjects receiving YSCH-01. To evaluate the effect of YSCH-01 on quality of life in patients with relapsed/refractory advanced solid tumors.

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.根据研究者判断，受试者有能力理解并遵守方案要求
2.在任何研究程序开始前，受试者签署书面知情同意书以及任何所需的隐私授权并注明日期。
3.自愿签署书面ICF并且签署ICF时年龄≥18周岁，性别不限。  
4.剂量递增阶段：组织学或细胞学确认的晚期恶性实体肿瘤受试者（包括但不限于卵巢癌、TNBC、NSCLC、头颈癌等），经标准治疗失败，或无标准治疗方案的末线受试者，或现阶段不适用标准治疗受试者。对于具有某些已知特殊突变或基因异常（如EGFR、ALK、ROS-1、BRAF、RET、MET和KRAS）的受试者，既往须接受过针对靶标的标准治疗（基于当地最新指南推荐），但研究者判定为标准治疗不适用、获益有限或不耐受（应记录不耐受的原因）的受试者除外。接受过抗PD-1标准治疗的PD-1难治性受试者，或未接受过抗PD-1治疗且无可用PD-1标准治疗的受试者将有资格入组。
剂量扩展阶段：
队列1：组织学或细胞学确认的不可切除的复发性或转移性头颈部鳞癌受试者。受试者需经既往抗PD-1单抗以及含铂化疗失败或不耐受。 
队列2：组织学或细胞学确认的晚期卵巢癌受试者，接受过含铂化疗，a）铂类难治：（完成首次含铂化疗后出现持续的疾病）至少在初次铂化疗中失败；b）铂类耐药：（在最后一次接受含铂化疗后6个月内出现疾病进展）至少在一个二线化疗方案中失败。铂类耐药性或难治性疾病受试者应接受过贝伐珠单抗联合化疗和单药维持治疗。伴BRCA突变的浆液性或高级别子宫内膜样卵巢癌、透明细胞癌、输卵管癌或原发性腹膜癌受试者应为在接受PARP抑制剂维持治疗后出现疾病进展。
队列3：组织学或细胞学确认的不可切除的晚期或转移性NSCLC受试者。受试者须接受标准治疗后有疾病进展，或对临床上适当的标准疗法不耐受。受试者接受过至少一线标准系统治疗，并在既往6个月内出现疾病进展。对于具有活化EGFR突变或ALK易位的NSCLC受试者，预期其对可用的酪氨酸激酶抑制剂治疗有应答，须在入组前接受过适用的酪氨酸激酶抑制剂治疗。
队列4：剂量递增阶段其他类似敏感瘤种，如不可切除的复发或转移性TNBC受试者。 
5.复发性、难治性和局部晚期疾病受试者有资格入组；但可治愈性、可切除疾病受试者无资格入组。
6.受试者有满足当前剂量队列要求的可注射的肿瘤病灶，包括浅表病灶，以及在超声/CT引导下可进行注射的深部病灶
7.受试者须至少存在一个按照RECIST 1.1标准判定为可测量的病灶，即根据CT或MRI横断面影像非淋巴结病灶长径≥10 mm，淋巴结病灶短径≥15 mm。既往放射疗法病灶不视为瘤内注射的靶病灶。 
8.受试者具有足够的血液学、肝、肾和疑血功能。ANC》1.0x10^9/L、血小板计数》75x10^9L、血红蛋白>80g/L、ALT≤ 3×ULN、AST ≤ 5×ULN、TBIL≤1.5×ULN、白蛋白》3g/dl、肌酐《1.5×ULN，凝血酶原时间 （PT）或国际标准化比率 (INR)<1.5×ULN
APTT<1.5xULN).
9.有生育能力的合格受试者(男性和女性)必须同意在试验期间和未次给药后至少六个月内使用可靠的避孕方法
10.有生育能力的女性(15-49 岁)必须在开始治疗前 7天内行妊娠试验且结果为阴性。
11.ECOG体能状态评分为 0-2，且预计生存期不少于 12 周的受试者。
12,所有由既往治疗或手术所致AE必须恢复至1级或基线。

Inclusion criteria

1. According to the investigator's judgment, the subject is capable of understanding and complying with the protocol requirements
2. Subject signs and dates written informed consent and any required privacy authorization prior to the commencement of any study procedure.
3. Sign a written ICF voluntarily and be at least 18 years old at the time of signing the ICF, regardless of gender.
4. Dose escalation stage: Subjects with histologically or cytologically confirmed advanced malignant solid tumors (including but not limited to ovarian cancer, TNBC, NSCLC, head and neck cancer, etc.), subjects who have failed standard treatment, or subjects who have no standard treatment options, or subjects who are not eligible for standard treatment at this stage. Subjects with certain known specific mutations or genetic abnormalities (e.g. EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS) must have previously received standard treatment for the target (based on the latest local guideline recommendations), Subjects are excluded if the investigator determines that standard treatment is not applicable, the benefit is limited, or intolerance (the cause of intolerance should be documented). Subjects with refractory PD-1 who have received anti-PD-1 standard therapy, or subjects who have not received anti-PD-1 therapy and do not have PD-1 standard therapy will be eligible for enrollment.
Dose expansion phase:
Cohort 1: Subjects with histologically or cytologically confirmed unresectable recurrent or metastatic head and neck squamous cell carcinoma. Subjects were required to have failed or been intolerant to previous anti-PD-1 monoclonal antibody and platinum-containing chemotherapy.
Cohort 2: Histologically or cytologically confirmed subjects with advanced ovarian cancer who had received platinum-containing chemotherapy and were a) platinum-refractory (persistent disease after completing the first platinum-containing chemotherapy) and had failed at least the first platinum chemotherapy; b) Platinum resistance: (disease progression within 6 months of the last platinum-containing chemotherapy) failure in at least one second-line chemotherapy regimen. Subjects with platinum-resistant or refractory disease should receive bevacizumab in combination with chemotherapy and monotherapy maintenance. Subjects with serous or high-grade endometrial ovarian cancer, clear cell cancer, fallopian tube cancer, or primary peritoneal cancer with BRCA mutations should develop disease progression following maintenance therapy with PARP inhibitors.
Cohort 3: Subjects with histologically or cytologically confirmed unresectable advanced or metastatic NSCLC. Subjects must have advanced disease after receiving standard therapy or be intolerant to clinically appropriate standard therapy. Participants had received at least first-line standard systemic therapy and had disease progression within the previous 6 months. NSCLC subjects with active EGFR mutations or ALK translocations who are expected to respond to available tyrosine kinase inhibitor therapy must have been treated with an applicable tyrosine kinase inhibitor prior to enrollment.
Cohort 4: Dose escalation phase for other similarly sensitive tumor species, such as subjects with unresectable recurrent or metastatic TNBC.
5. Subjects with recurrent, refractory and locally advanced diseases were eligible for inclusion; However, subjects with curable and resectable diseases were not eligible to be enrolled.
6. Subjects had injectable tumor lesions that met the requirements of the current dose cohort, including superficial lesions and deep lesions that could be injected under ultrasound /CT guidance
7. Subjects must have at least one lesion that is measurable according to RECIST 1.1 criteria, i.e., non-lymph node lesion ≥10 mm in diameter and lymph node lesion ≥15 mm in diameter based on cross-sectional CT or MRI images. Previous radiation therapy lesions are not considered targets for intratumoral injection.
8. The subject has adequate hematological, liver, kidney, and hypohematological functions. ANC "1.0x10^9/L, Platelet count" 75x10^9L, hemoglobin >80g/L, ALT≤ 3×ULN, AST ≤ 5×ULN, TBIL≤1.5×ULN, albumin "3g/dl, creatinine" 1.5×ULN, Prothrombin time (PT) or International standardized ratio (INR)<1.5×ULN
XULN APTT < 1.5).
9. Eligible subjects (male and female) who are fertile must consent to the use of a reliable method of contraception during the trial and for at least six months after the first dose
10. Fertile women (15-49 years of age) must undergo a pregnancy test within 7 days of starting treatment and the result is negative.
11. Subjects with an ECOG fitness status score of 0-2 and expected survival of at least 12 weeks.
12, all aes due to previous treatment or surgery must return to grade 1 or baseline.

排除标准：

1. 受试者在研究第1天前21天内接受过化疗或抗体治疗，在研究第1天前14天内接受过分子靶向治疗、激素治疗、治疗性或姑息性放疗。 2. 受试者患有治疗后未稳定控制的全身性疾病，如糖尿病、严重器质性心脑血管疾病、心功能不全、高血压、II度以上心脏传导阻滞、既往6个月内心肌梗死，或既往6个月内脑梗死等。 3. 用于注射的病灶最长直径>100 mm。 4. 受试者患有未控制的感染性疾病，活动性乙型肝炎（既往6个月内，抗乙型肝炎核心[HBc]抗体阳性且乙型肝炎病毒[HBV]-DNA>研究中心检测下限[LLOD]）；活动性丙型肝炎（既往6个月内，抗丙型肝炎病毒[HCV]抗体阳性，且HCV RNA载量>LLOD）；既往3个月内，抗人免疫缺陷病毒（HIV）-1或HIV-2抗体阳性，且CD4+ T细胞≤300个/uL。 5. 根据不良事件通用术语标准（CTCAE）v5.0，受试者有未控制的≥3级活动性感染且具有显著临床相关性。 6. 既往5年内患有其他活动性恶性肿瘤的受试者。已经完全治愈且不需要随访治疗的受试者除外，恶性肿瘤在适应症范围内的受试者除外。 7. 受试者有位于高风险位置的肿瘤（包括位于粘膜区，或靠近气道、大血管或脊髓），其可能导致因肿瘤肿大而造成闭塞或压迫，或因坏死而侵蚀到主要血管，或包裹主要的血管结构（如颈动脉），与重要的神经血管结构相邻的肿瘤，或其他被认为不适合瘤内注射的肿瘤。 8. 受试者患有活动性自身免疫性疾病或有病史且有可能复发，如溃疡性结肠炎、克罗恩病、类风湿性关节炎、系统性红斑狼疮、自身免疫性血管炎或韦格纳肉芽肿病，但允许患以下疾病的受试者入组：只需接受激素替代治疗的自身免疫性甲状腺功能减退症；无需进行全身治疗的皮肤疾病（如湿疹，占体表10%以下的皮疹）。 9. 受试者对研究药物、免疫治疗或相关药物的任何成分过敏。 10.器官功能障碍者。心血管系统：纽约心病学会NYHA心功能分级III级及以上的充血性心力衰竭病史或相关发现；或经标准治疗法控制的高血压(收缩压》150mmHg且舒张压》90 mmHg)，既往一年内有心肌炎或心肌梗死病史；泌尿系统：蛋白尿》3级；肺系统：有需要类固醇治疗的肺炎(非感染性)病史，或肺炎现病史；中枢神经系统：需要治疗的症状性转移、活动性出血、血栓性疾病。无症状和稳定的脑转移受试有资格入组。 11. 受试者在入组前14天或研究期间需接受全身皮质类固醇（相当于>10 mg泼尼松/天）。以下情况的受试者有资格入组队列：局部或吸入使用皮质类固醇，或短期（≤7天）使用糖皮质激素以预防或治疗非自身免疫性过敏性疾病。 12. 受试者不具有法律行为能力或其法律行为能力受限，无法完成知情同意。 13. 受试者在既往4周内或5个半衰期内参加过其他药物或医疗器械的临床试验。 14. 受试者患有严重且无法控制的疾病或其他可能影响其参与本研究的疾病，具体情况由研究者判定。 15. 女性受试者处于妊娠期或哺乳期。 16. 受试者在筛选期和治疗期需接种任何活疫苗。

Exclusion criteria：

1. Subjects received chemotherapy or antibody therapy within 21 days prior to study day 1 and molecular targeted therapy, hormone therapy, therapeutic or palliative radiotherapy within 14 days prior to study day 1. 2. The subjects had systemic diseases that were not under stable control after treatment, such as diabetes mellitus, severe organic cardiovascular and cerebrovascular diseases, cardiac insufficiency, hypertension, heart block above grade II, myocardial infarction within the past 6 months, or cerebral infarction within the past 6 months, etc. 3. The maximum diameter of the lesion for injection is >100 mm. 4. The subject has an uncontrolled infectious disease, active hepatitis B (positive anti-hepatitis B core [HBc] antibody and hepatitis B virus [HBV]-DNA> Center detection limit [LLOD] within the previous 6 months); Active hepatitis C (positive for antibodies against hepatitis C virus [HCV] and HCV RNA load >LLOD within the previous 6 months); Positive antibodies against human immunodeficiency virus (HIV) -1 or HIV-2 and CD4+ T cells ≤300 /uL within the previous 3 months. 5. Subject had an uncontrolled ≥ grade 3 active infection with significant clinical relevance according to CTCAE (Common Terminology Standard for Adverse Events) v5.0. 6. Subjects with other active malignancies within the previous 5 years. Subjects who have been completely cured and do not require follow-up treatment are excluded, and subjects whose malignant tumors are within the indications are excluded. 7. Subjects have tumors located at a high risk (including in the mucosal area, or near the airway, large blood vessels, or spinal cord) that may lead to occlusion or compression by tumor enlargement, or erosion of major blood vessels by necrosis, or enveloping major vascular structures (such as the carotid artery), adjacent to important neurovascular structures. Or other tumors deemed unsuitable for intratumoral injection. 8. Subjects had or had a history of an active autoimmune disease with the potential for recurrence, such as ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, autoimmune vasculitis, or Wegener's granulomatosis, but subjects were admitted with: autoimmune hypothyroidism requiring hormone replacement therapy; Skin conditions that do not require systemic treatment (e.g. eczema, a rash that accounts for less than 10% of the body surface). 9. The subject is allergic to any component of the investigational drug, immunotherapy, or related drug. 10. People with organ dysfunction. Cardiovascular system: History or findings of congestive heart failure at NYHA level III or above; Or hypertension controlled by standard therapy (systolic blood pressure of 150mmHg and diastolic blood pressure of 90 mmHg), and a history of myocarditis or myocardial infarction within the past year; Urinary system: proteinuria grade 3; Pulmonary system: a history of pneumonia (non-infectious) requiring steroid treatment, or a history of pneumonia present; Central nervous system: symptomatic metastasis, active bleeding, thrombotic disease requiring treatment. Subjects with asymptomatic and stable brain metastases were eligible for inclusion. 11. Subjects received a systemic corticosteroid (equivalent to >10 mg prednisone/day) for 14 days prior to enrollment or during the study period. Subjects were eligible for inclusion in the cohort with topical or inhaled corticosteroid use, or short-term (≤7 days) corticosteroid use for the prevention or treatment of non-autoimmune allergic diseases. 12. The subjects do not have legal capacity or their legal capacity is limited and they cannot complete informed consent. 13. Subjects have participated in clinical trials of other drugs or medical devices within the previous 4 weeks or 5 half-lives. 14. Subjects have a serious and uncontrollable illness or other illness that may affect their participation in the study, as determined by the investigator. 15. Female subjects are pregnant or lactating. 16. Subjects are required to receive any live vaccine during the screening and treatment periods.

研究实施时间：

Study execute time：

从 From 2024-05-10 00:00:00至 To 2026-05-10 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-05-10 00:00:00 至 To 2026-05-10 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	49
Group：	Experimental group	Sample size：	49
干预措施：	重组 L-IFN 腺病毒注射液	干预措施代码：
Intervention：	Recombinant L-IFN adenovirus injection	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	山东	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	山东第一医科大学附属肿瘤医院	单位级别：	三甲
Institution hospital：	Affiliated Cancer Hospital of Shandong First Medical University	Level of the institution：	Tertiary A

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：	三甲
Institution hospital：	Cancer Hospital, Chinese Academy of Medical Sciences	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	不良事件/严重不良事件的发生率和特征	指标类型：	主要指标
Outcome：	Incidence and characteristics of adverse events/serious adverse events	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	剂量限制毒性发生率和特征	指标类型：	主要指标
Outcome：	Incidence and characteristics of dose-limiting toxicity	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	最大耐受剂量	指标类型：	主要指标
Outcome：	Maximum tolerable dose	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	药代动力学指标	指标类型：	主要指标
Outcome：	Pharmacokinetic indicators	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	药效动力学指标	指标类型：	主要指标
Outcome：	Pharmacodynamic indicators	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	免疫原性指标	指标类型：	主要指标
Outcome：	Indicators of immunogenicity	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：	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：

标本中文名：	粪便	组织：
Sample Name：	Faeces	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：	鼻咽液	组织：
Sample Name：	Nasopharyngeal fluid	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：	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：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age		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）：

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）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	中国临床试验注册中心 http://www.chictr.org.cn
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	China Clinical Trial Cencer(http://www.chictr.org.cn)
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：	EDC
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：	2024-05-07 15:06:52