ChiCTR2600127138 版本V1.0 版本创建时间2026/06/25 11:56:23 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：

 ChiCTR2600127138 

最近更新日期：

Date of Last Refreshed on：

 2026-06-25 11:56:14 

注册时间：

Date of Registration：

 2026-06-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

比较全身化疗联合信迪利单抗加或不加白蛋白紫杉醇腹腔灌注治疗初诊HER2阴性胃/食管胃结合部腺癌伴腹膜转移患者的III期随机对照研究

Public title：

A Phase III Randomized Controlled Study Comparing Systemic Chemotherapy Combined with Sintilimab with or Without Albumin-Bound Paclitaxel for Intraperitoneal Perfusion in the Treatment of Previously Untreated HER2-Negative Gastric/Gastroesophageal Junction Adenocarcinoma with Peritoneal Metastasis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

比较全身化疗联合信迪利单抗加或不加白蛋白紫杉醇腹腔灌注治疗初诊HER2阴性胃/食管胃结合部腺癌伴腹膜转移患者的III期随机对照研究

Scientific title：

A Phase III Randomized Controlled Study Comparing Systemic Chemotherapy Combined with Sintilimab with or Without Albumin-Bound Paclitaxel for Intraperitoneal Perfusion in the Treatment of Previously Untreated HER2-Negative Gastric/Gastroesophageal Junction Adenocarcinoma with Peritoneal Metastasis

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：

聂润聪 

研究负责人：

李元方 

Applicant：

Nie Runcong 

Study leader：

Li Yuanfang 

申请注册联系人电话：

Applicant telephone：

 +86 15626447119

研究负责人电话：

Study leader's
telephone：

+86 135 0306 5940

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：

 nierc@sysucc.org.cn

研究负责人电子邮件：

Study leader's E-mail：

 hradalam@ust.hk

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：

广东省广州市东风东路651号

研究负责人通讯地址：

广东省广州市东风东路651号

Applicant address：

No. 651, Dongfeng East Road, Guangzhou, Guangdong Province.

Study leader's address：

No. 651, Dongfeng East Road, Guangzhou, Guangdong 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：

中山大学肿瘤防治中心

Applicant's institution：

Sun Yat-sen University Cancer Center

研究负责人所在单位：

中山大学肿瘤防治中心

Affiliation of the Leader：

Sun Yat-sen University Cancer Center

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：

 B2025-885-01

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：

中山大学肿瘤防治中心伦理委员会

Name of the ethic committee：

Institutional Review Board of Sun-Yat sen University Cancer Center

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-01-14 00:00:00

伦理委员会联系人：

潘旭芝

Contact Name of the ethic committee：

Pan XuZhi

伦理委员会联系地址：

广东省广州市东风东路651号

Contact Address of the ethic committee：

No. 651, Dongfeng East Road, Guangzhou, Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 87343009

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 panxzh@sysucc.org.cn

研究实施负责（组长）单位：

中山大学肿瘤防治中心

Primary sponsor：

Sun Yat-sen University Cancer Center

研究实施负责（组长）单位地址：

广东省广州市东风东路651号

Primary sponsor's address：

No. 651, Dongfeng East Road, Guangzhou, Guangdong 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)：

广东省

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

中山大学肿瘤防治中心

具体地址：

广东省广州市东风东路651号

Institution
hospital：

Sun Yat-sen University Cancer Center

Address：

No. 651, Dongfeng East Road, Guangzhou, Guangdong Province

经费或物资来源：

比较全身化疗联合信迪利单抗加或不加白蛋白紫杉醇腹腔灌注治疗初诊HER2阴性胃/食管胃结合部腺癌伴腹膜转移患者的III期随机对照研究

Source(s) of funding：

No source of funding

研究疾病：

治疗初诊HER2阴性胃/食管胃结合部腺癌伴腹膜转移疾病  

Target disease：

To treat newly diagnosed HER2-negative gastric/esophagogastric junction adenocarcinoma with peritoneal metastasis

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

比较全身化疗联合信迪利单抗加或不加白蛋白紫杉醇腹腔灌注治疗初诊HER2阴性胃/食管胃结合部腺癌伴腹膜转移患者的疗效和安全性。  

Objectives of Study：

To compare the efficacy and safety of systemic chemotherapy combined with sintilimab with or without albumin paclitaxel intraperitoneal perfusion in the treatment of newly diagnosed HER2-negative gastric/esophagogastric junction adenocarcinoma with peritoneal metastasis.

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）对本研究已充分了解并自愿签署知情同意书（ICF）；
2）初诊未治疗的组织学确诊胃/食管胃结合部腺癌，根据腹腔镜检查明确为腹膜转移（腹水细胞学阳性或腹膜结节病理阳性）患者，临床分期IV期；
3）根据RECIST(V1.1)标准，有可评价或不可评价病灶。除外区域淋巴结转移病灶外，仅限一个以下单一不可切除转移器官：a) 1-2个1-3cm的肝转移；b) 腹主动脉旁a2/b1转移；c) 卵巢转移。
4）免疫组化为HER2(0)、HER2(1+)或HER2(2+)且FISH检测阴性；
5）同意提供既往储存的肿瘤组织标本或者进行活检以采集肿瘤病灶组织送往中心实验室进行HER2、PD-L1、EBV、MSI IHC 检测；
6）性别不限，年龄18-75周岁；
7）一般状况好，ECOG评分在0-1分；
8）患者愿意接受从首次研究用药前28天内经腹腔镜或者开放性手术放置腹腔化疗港，并愿意接受腹腔化疗；
9）预期生存期 ≥ 6月；
10）入组前 7 天内实验室检查值必须符合以下标准： a. WBC > 4.0×109/L和 < 15×109/L，ANC > 1.5×109/L，Hb ≥ 80g/L，PLT ≥ 100×109/L； b. 血清胆红素 ≤ 1.5×ULN(正常值高限)，AST、ALT ≤ 2.5×ULN； c. 肌酐 ≤ 1.5×ULN且血清清除率 > 60ml/min，根据Cockcroft-Gault 肾小球滤过率预估值： （140 ? 年龄）×（体重， kg）×（0.85，如果是女性） 72 ×（血清肌酐， mg/dL） 或： （140 ? 年龄）×（体重， kg）×（0.85，如果是女性） 0.818 ×（血清肌酐， umol/L） d. INR 和 aPTT ≤ 1.5 × ULN，仅适用于未接受抗凝治疗的受试者；接受抗凝治疗受试者应采用稳定剂量；
11）依从性好，可配合本方案的实验室、辅助检查以及相应的标本收集；
12）具有生育能力的女性（包括因化学绝经或其他医学原因导致绝经的女性）必须同意在从签署知情同意书到研究治疗或伴随化疗末次给药后至少5个月（以较晚者为准）期间采取避孕措施。女性也必须同意在从签署知情同意书到研究药物或伴随化疗末次给药后至少5个月（以较晚者为主）期间不进行哺乳；男性必须同意在从试验药品给药到试验药品或伴随化疗给药后至少7个月（以较晚者为主）期间采取避孕措施。

Inclusion criteria

1. Have fully understood this research and voluntarily signed the Informed Consent Form (ICF); 2. Patients who were initially diagnosed with adenocarcinoma of the gastric/esophagogastric junction without treatment and were confirmed to have peritoneal metastasis (positive ascites cytology or positive peritoneal nodule pathology) through laparoscopy, with a clinical stage of IV; 3. According to the RECIST (V1.1) standard, there are evaluable or unevaluable lesions. Excluding regional lymph node metastatic lesions, only one or fewer single unresectable metastatic organs are allowed: (1) 1-2 liver metastases of 1-3 cm; (2) Para-aortic a2/b1 metastasis; (3) Ovarian metastasis. 4. Immunohistochemistry shows HER2(0), HER2(1+) or HER2(2+), and FISH test is negative; 5. Agree to provide previously stored tumor tissue specimens or conduct biopsies to collect tumor lesion tissues for sending to the central laboratory for HER2, PD-L1, EBV, and MSI IHC detection; 6. Gender is not limited. Age: 18 to 75 years old; 7. Generally in good condition, with an ECOG score ranging from 0 to 1; 8. The patient is willing to receive intraperitoneal chemotherapy port placed through laparoscopy or open surgery within 28 days before the first study of medication and is willing to undergo intraperitoneal chemotherapy; 9. Expected survival period >= 6 months; 10. Laboratory test values within 7 days before enrollment must meet the following standards: (1) WBC > 4.0 x 10^9/L and < 15 x 10^9/L, ANC > 1.5 x 10^9/L, Hb >= 80 g/L, PLT >= 100 x 10^9/L; (2) Serum bilirubin <= 1.5 x ULN (upper limit of normal value), AST and ALT <= 2.5 x ULN; (3) Creatinine <= 1.5 x ULN and serum clearance rate > 60 ml/min, based on the predicted glomerular filtration rate by Cockcroft-Gault: (140 - age) x (weight, kg) x (0.85, if female) / [72 x (Serum creatinine, mg/dL)] Or: (140 - age) x (weight, kg) x (0.85, if female) / [0.818 x (Serum creatinine, umol/L)]; (4) INR and aPTT <= 1.5 x ULN, only applicable to subjects who have not received anticoagulation therapy; subjects receiving anticoagulant therapy should be given a stable dose; 11. Good compliance, capable of cooperating with the laboratory, auxiliary examinations and corresponding specimen collection of this plan; 12. Fertile women (including those who have experienced menopause due to chemopenmenopause or other medical reasons) must agree to take contraceptive measures for at least five months (whichever is later) from the time of signing the informed consent form until the last administration of the study treatment or accompanying chemotherapy. Women must also agree not to breastfeed for at least five months (preferably later) from the signing of the informed consent form to the last administration of the study drug or accompanying chemotherapy. Men must agree to take contraceptive measures for at least 7 months (whichever is later) from the administration of the investigational drug to the administration of the investigational drug or in conjunction with chemotherapy.

排除标准：

1）已知对试验药物的组分过敏的；
2）既往或现在同时患有其它恶性肿瘤（完全切除的基底细胞癌、I期鳞状细胞癌、原位癌、粘膜内癌、浅表膀胱癌或任何其他已至少5年未复发的癌症除外）；
3）首次研究用药前7天内下列疾病尚未缓解到CTCAE 0-1级： ?急性或慢性胰腺炎； ?未控制的急、慢性感染，例如：肺炎、胆道感染、乙型肝炎病毒感染和丙型肝炎病毒感染等； ?腹泻； ?肠梗阻、消化道穿孔、消化道出血或有出血高风险； ?呼吸困难； 4）无法口服药物；
5）NYHA评级3或4级；
6）相关心血管疾病的症状以及体征：包括心肌梗死、充血性心力衰竭、心律失常等；
7）已知的脑血管意外事件；
8）首次研究用药前30天内有化疗、放疗等病史；
9）首次研究用药前30天内使用过抗HER2、抗PD-1抗体、抗PD-L1抗体、抗PD-L2抗体或抗CTLA-4抗体（或作用于T细胞协同刺激或检查点通路的任何其它抗体）、Claudin18.2单抗、酪氨酸激酶抑制剂等药物；
10）患有需要长期使用免疫抑制药物治疗、或需要全身或局部使用具有免疫抑制作用剂量（剂量 > 10mg/天的泼尼松或其它等疗效激素）的皮质类固醇的合并症；
11）入组前4周内接种过任何抗感染疫苗（如流感疫苗、水痘疫苗等）；
12）未得到控制的糖尿病、高血压等全身性疾病；
13）受试者存在任何活动性自身免疫性疾病或有自身免疫性疾病病史（包括但不限于：间质性肺炎、葡萄膜炎、肠炎、肝炎、垂体炎、肾炎、甲状腺功能亢进、甲状腺功能降低；患有白癜风或在童年期哮喘已完全缓解，成人后无需任何干预的受试者可纳入；患有需要支气管扩张剂进行医学干预的哮喘则不能纳入）；
14）患有活动性肺结核（TB）的受试者，正在接受抗结核治疗或者筛选前1年内接受过抗结核治疗；
15）根据影像学（最好是CT）或临床结果确诊有以下肺部疾病史：间质性肺炎、非感染性肺炎、肺纤维化、急性肺疾病；
16）妊娠或哺乳期妇女或可能妊娠者；
17）以下任何检查的结果阳性：人类免疫缺陷病毒-1（HIV-1）抗体、人类免疫缺陷病毒-2（HIV-2）抗体、人嗜T淋巴细胞病毒-1（HTLV-1）抗体、丙型肝炎病毒（HCV）抗体；
18）研究者认为可影响方案依从性，或影响受试者签署知情同意书（ICF），或不适宜参加本临床试验的具有临床意义的任何其它疾病或状况。

Exclusion criteria：

1. Known to be allergic to a component of the test drug; 2. Previous or current concurrent cancer with another malignancy (except completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, or any other cancer without recurrence for at least 5 years); 3. Absence of resolution to CTCAE grade 0-1 within 7 days before the first dose of study medication: (1) Acute or chronic pancreatitis; (2) Uncontrolled acute and chronic infections, such as pneumonia, biliary tract infection, hepatitis B virus infection and hepatitis C virus infection; (3) Diarrhea; (4) Intestinal obstruction, gastrointestinal perforation, gastrointestinal bleeding or high risk of bleeding; (5) Difficulty breathing; 4. Unable to take oral medication; 5. NYHA grade 3 or 4; 6. Symptoms and signs of related cardiovascular diseases, including myocardial infarction, congestive heart failure, arrhythmia, etc.; 7. Known cerebrovascular events; 8. The history of chemotherapy or radiotherapy within 30 days before the first study medication; 9. Use of anti-HER2, anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 (or any other antibody acting on T cell costimulation or checkpoint pathway), Claudin18.2 monoclonal antibody, or tyrosine kinase inhibitor within 30 days before the first study dose; 10. Have comorbidities requiring long-term treatment with immunosuppressive drugs or systemic or topical corticosteroids at immunosuppressive doses (prednisone or other therapeutic hormones at a dose > 10 mg/day); 11. Received any anti-infective vaccine (e.g., influenza vaccine, varicella vaccine, etc.) within 4 weeks before enrollment; 12. Uncontrolled systemic diseases such as diabetes and hypertension; 13. Subjects with any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; vitiligo or complete remission of asthma in childhood without any intervention in adulthood; patients with asthma requiring medical intervention with bronchodilators were excluded); 14. Subjects with active pulmonary tuberculosis (TB) who were receiving anti-TB treatment or had received anti-TB treatment within 1 year before screening; 15. A history of the following lung diseases as confirmed by imaging (preferably CT) or clinical findings: interstitial pneumonia, noninfectious pneumonia, pulmonary fibrosis, acute lung disease; 16. Pregnant or lactating women or those who may become pregnant; 17. A positive test for any of the following: antibody to human immunodeficiency virus-1 (HIV-1), antibody to human immunodeficiency virus-2 (HIV-2), antibody to human T-lymphotropic virus-1 (HTLV-1), antibody to hepatitis C virus (HCV); 18. Any other clinically significant disease or condition considered by the investigator to affect adherence to the protocol, or to affect the signing of the Informed Consent Form (ICF), or to preclude participation in the trial.

研究实施时间：

Study execute time：

从 From 2026-01-26 00:00:00至 To 2030-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-25 00:00:00 至 To 2028-12-31 00:00:00

干预措施：

Interventions：

组别：

试验组（A组）

样本量：

 172

Group：

Experimental group (group A)

Sample size：

干预措施：

SOX+信迪利单抗组（A组）

干预措施代码：

Intervention：

SOX+ sintilimab group (group A)

Intervention code：

组别：

对照组（B组）

样本量：

 172

Group：

Control group (group B)

Sample size：

干预措施：

SOX+信迪利单抗+白蛋白紫杉醇腹腔化疗组（B组）

干预措施代码：

Intervention：

SOX+ sintilimab + albumin paclitaxel intraperitoneal chemotherapy group (group B)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 中山大学肿瘤防治中心 

单位级别：

 三级甲等 

Institution
hospital：

Sun Yat-sen University Cancer Center

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

治疗期间不良事件、严重不良事件 TEAE/SAE 发生率

指标类型：

次要指标

Outcome：

Incidence of adverse events and serious adverse events TEAE/SAE during treatment

Type：

Secondary indicator

测量时间点：

研究结束时统计

测量方法：

通过对AE、SAE的类型、发生率、严重程度、转归及与试验药物的因果关系等总结来评价其安全性。

Measure time point of outcome：

Statistics were made at the end of the study

Measure method：

The safety was evaluated by summarizing the types, incidence, severity, outcome and causal relationship with the trial drugs of AE and SAE.

指标中文名：

总生存期（OS）

指标类型：

主要指标

Outcome：

Overall survival (OS)

Type：

Primary indicator

测量时间点：

术后随访

测量方法：

利用 log-rank 进行OS 的生存分析。

Measure time point of outcome：

Postoperative FOLLOW-UP

Measure method：

Survival analysis of OS was conducted using log-rank.

指标中文名：

安全性：不良事件的发生率和严重程度、有临床意义的异常实验室检查结果；术后 30 天内出现的手术并发症

指标类型：

次要指标

Outcome：

Safety: the incidence and severity of adverse events, clinically significant abnormal laboratory test results; Surgical complications within 30 days after surgery

Type：

Secondary indicator

测量时间点：

术后30天，定期随访，得出检查结果时。

测量方法：

统计与分析数据信息

Measure time point of outcome：

30 days after surgery, regular follow-up, when the test results are obtained.

Measure method：

Statistics and analysis of data information

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：

术后随访

测量方法：

Measure time point of outcome：

Postoperative FOLLOW-UP

Measure method：

指标中文名：

治疗后的转化手术 R0 切除率

指标类型：

次要指标

Outcome：

R0 resection rate of conversion surgery after treatment

Type：

Secondary indicator

测量时间点：

术后送检标本病理诊断

测量方法：

在显微镜下观察被切除的肿瘤各个切缘是否有癌细胞

Measure time point of outcome：

Postoperative specimens were sent for pathological diagnosis

Measure method：

Each margin of the resected tumor was observed for cancer cells under a microscope

指标中文名：

生活质量 ： EORTC QLQ-C30 (version 3) 、 EORTC QLQ- STO22、EQ-5D-5L 调查问卷

指标类型：

次要指标

Outcome：

Quality of life: EORTC QLQ-C30 (version 3), EORTC QLQ-STO22, EQ-5D-5L questionnaire

Type：

Secondary indicator

测量时间点：

治疗前、第三程、第六程、第九程

测量方法：

受试者在治疗前、第三疗程、第六疗程、第九疗程时填写生活质量调查问卷，治疗结束后由研究者和研究相关人员整理、统计和分析。

Measure time point of outcome：

Before treatment, the third treatment, the sixth treatment, the ninth treatment

Measure method：

The subjects filled out the quality of life questionnaire before treatment, during the third course, the sixth course and the ninth course. After the treatment, the researchers and relevant personnel of the study sorted, statistically analyzed and analyzed it.

指标中文名：

肿瘤客观缓解率（ORR）

指标类型：

次要指标

Outcome：

Objective Response Rate (ORR)

Type：

Secondary indicator

测量时间点：

术后送检标本病理诊断

测量方法：

病理学诊断

Measure time point of outcome：

Postoperative specimens were sent for pathological diagnosis

Measure method：

Pathological diagnosis

指标中文名：

情绪相关量表：PHQ-9、GAD-7 情绪量表

指标类型：

次要指标

Outcome：

Emotional scale: PHQ-9, GAD-7 emotional scale

Type：

Secondary indicator

测量时间点：

治疗前、第三程、第六程、第九程

测量方法：

受试者在治疗前、第三疗程、第六疗程、第九疗程时填写情绪相关量表：PHQ-9、GAD-7 情绪量表，治疗结束后由研究者和研究相关人员整理、统计和分析。

Measure time point of outcome：

Before treatment, the third treatment, the sixth treatment, the ninth treatment

Measure method：

The subjects filled out the emotion-related scales: PHQ-9 and GAD-7 emotion scales before treatment, during the third course of treatment, the sixth course of treatment, and the ninth course of treatment. After the treatment, the researchers and relevant personnel of the research sorted, statistically analyzed and analyzed them.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

胃癌原发组织

组织：

Sample Name：

Primary gastric cancer tissue

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

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：

腹膜转移病灶活检物

组织：

Sample Name：

Biopsy material from peritoneal metastatic lesions

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）：

由研究助理通过IWRS随机系统设置参数产生随机数列进行随机。

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

Random sequence was generated by the research assistant through the IWRS random system setting parameters for randomization.

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：

开放标签，对评估者隐藏分组

Blinding：

Open-label study with blinded-evaluators

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）：

无

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

None

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、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：

A standard data collection and management system incude a CRF and an electronic data capture.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-06-25 11:56:14