ChiCTR2600117773 版本V1.0 版本创建时间2026/01/28 16:23:23 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：

ChiCTR2600117773 

最近更新日期：

Date of Last Refreshed on：

2026-01-28 16:23:05 

注册时间：

Date of Registration：

2026-01-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

探索卡度尼利单抗、法米替尼联合化疗在晚期卵巢癌治疗中的有效性和安全性

Public title：

A Study to Evaluate the Efficacy and Safety of Cadonilimab Plus Famitinib in Combination With Chemotherapy for Advanced Ovarian Cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

探索卡度尼利单抗、法米替尼联合化疗在晚期卵巢癌治疗中的有效性和安全性

Scientific title：

A Study to Evaluate the Efficacy and Safety of Cadonilimab Plus Famitinib in Combination With Chemotherapy for Advanced Ovarian 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：

汪希鹏 

研究负责人：

汪希鹏 

Applicant：

Xipeng Wang 

Study leader：

Xipeng Wang 

申请注册联系人电话：

Applicant telephone：

+86 21 2507 8999

研究负责人电话：

Study leader's telephone：

+86 21 2507 8999

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：

wangxipeng@xinhuamed.com.cn

研究负责人电子邮件：

Study leader's E-mail：

wangxipeng@xinhuamed.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：

上海市杨浦区控江路1665号

研究负责人通讯地址：

上海市杨浦区控江路1665号

Applicant address：

1665 Kongjiang Road, Shanghai, China.

Study leader's address：

1665 Kongjiang Road, Shanghai, China.

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：

上海交通大学医学院附属新华医院

Applicant's institution：

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

研究负责人所在单位：

上海交通大学医学院附属新华医院

Affiliation of the Leader：

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

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：

XHEC-C-2025-143-4

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：

上海交通大学医学院附属新华医院医学伦理委员会

Name of the ethic committee：

Ethics Committee of Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025-11-21 00:00:00

伦理委员会联系人：

施敏

Contact Name of the ethic committee：

Shi Min

伦理委员会联系地址：

上海市杨浦区控江路1665号

Contact Address of the ethic committee：

1665 Kongjiang Road, Shanghai, China.

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 25076143

伦理委员会联系人邮箱：

Contact email of the ethic committee：

shiminxh@163.com

研究实施负责（组长）单位：

上海交通大学医学院附属新华医院

Primary sponsor：

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

研究实施负责（组长）单位地址：

上海市杨浦区控江路1665号

Primary sponsor's address：

1665 Kongjiang Road, Shanghai, China.

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

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海交通大学医学院附属新华医院

具体地址：

上海市杨浦区控江路1665号

Institution
hospital：

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Address：

1665 Kongjiang Road, Shanghai, China.

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

self-financed

Target disease：

advanced ovarian cancer

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：

主要目的：评价卡度尼利单抗、法米替尼联合化疗作为新辅助治疗对晚期卵巢癌患者的R0手术切除率影响。 次要目的：评价卡度尼利单抗、法米替尼联合化疗作为新辅助治疗对晚期卵巢癌患者的客观缓解率（ORR）、病理缓解率（pCR）、无进展生存期和总生存期、近期和远期安全性、以及对生活质量的影响。 探索性目的：探索卡度尼利单抗、法米替尼联合化疗作为新辅助治疗使用前后肿瘤免疫相关因子及细胞的变化，筛选预测卡度尼利单抗、法米替尼联合化疗作为新辅助治疗有效性的生物指标。  

Objectives of Study：

Primary Objective:To evaluate the impact of cadonilimab combined with famitinib and chemotherapy as neoadjuvant therapy on the rate of R0 surgical resection in patients with advanced ovarian cancer. Secondary Objectives:To evaluate the effects of cadonilimab combined with famitinib and chemotherapy as neoadjuvant therapy on objective response rate (ORR), pathological complete response (pCR), progression-free survival (PFS), and overall survival (OS) in patients with advanced ovarian cancer, as well as to assess short-term and long-term safety and the impact on quality of life. Exploratory Objectives:To explore changes in tumor immune-related factors and immune cell populations before and after treatment with cadonilimab combined with famitinib and chemotherapy as neoadjuvant therapy, and to identify potential biomarkers predictive of treatment efficacy.

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.在试验任何程序开始之前，必须签署知情同意书，并将知情同意书在研究中心备案; 2.年龄大于等于18的女性患者； 3.开放式手术、腹腔镜手术或粗针穿刺取得活检，病理证实为高级别浆液性或子宫内膜样卵巢癌、腹膜癌或输卵管癌（以下简称卵巢癌）； 4. FIGO分期III-IV期； 5. 患者治疗前、期间、后的血液和组织标本可以获取，且受试者同意将血液和组织标本交予中心实验室用于该试验的拓展研究目的，包括但不限于：i.可能的基因相关研究。ii.可能的肿瘤标识物相关研究； 6.存在至少一个可被CT/MRI测量的病灶； 7.认为不适合初次减瘤术（PDS）: (1)符合围术期并发症高风险的MAYO标准； (2)如果影像学不能确定肿瘤是否不可切除，首选腹腔镜检查。腹腔镜下Fagotti评分**≥8分，小肠广泛受累或肠系膜挛缩 MAYO标准，满足以下1项以上的条件： ①白蛋白<3.5g/dl； ②年龄≥80岁； ③年龄75-79岁，且存在以下条件之一：PS>1（ASA 3-4）；或IV期（多发肝转移或肺转移）；或复杂的术式（超出子宫+双附件+大网膜切除）； 近6月内：VTE；或心梗；或血管支架置入；或开腹手术。 Fagotti评分（每项2分） ①大块/粟粒样腹膜种植病灶； ②大网膜饼累及胃大弯处； ③广泛腹膜浸润性病灶及/或大部分膈面受累； ④肠系膜根部受累； ⑤小肠/大肠切除及/或肠袢上病灶广泛种植； ⑥肿瘤浸润胃壁；⑦ 肝表面病灶>2cm。 8. 预期生存期＞12周； 9. 患者ECOG评分为0-2； 10. 具有良好的器官功能，患者需满足如下实验室指标： (1)近14天未使用粒细胞集落刺激因子的情况下，中性粒细胞绝对值（ANC）≥1.5×10^9/L。 (2)近14天未输血的情况下，血小板≥100×10^9/L。 (3)近14天内无输血或使用促红细胞生成素的情况下，血红蛋白>9g/dL； (4)总胆红素≤1.5×正常值上限（ULN）；天门冬氨酸转氨酶（AST）、丙氨酸转氨酶（ALT）在≤2.5×ULN（有肝转移的患者允许ALT 或AST ≤5×ULN）； (5)血肌酐≤1.5×ULN或肌酐清除率（采用Cockcroft-Gault 公式计算CrCL(mL/min)={(140-年龄)×体重(kg)×0.85}/(SCr(mg/dL)×72)）≥50 ml/min； (6)凝血功能良好，定义为国际标准化比值（INR）或凝血酶原时间（PT）≤1.5倍ULN； 11.对于有生育潜能的女性，入组前一周内查血或尿妊娠试验阴性，入组后必须采取有效地避孕措施，例如：使用物理屏障避孕方法（避孕套）或完全禁欲。不允许口服，注射或植入激素避孕药。或无生育潜能女性，无生育潜能定义为：i.自然进入更年期且停经1年以上；ii.手术绝育（双侧卵巢切除术，双侧输卵管切除术或子宫切除术）；iii.血清卵泡刺激素，促黄体激素和血浆雌二醇水平在研究中心实验室的绝经标准内。 12.理解试验流程而且有能力在试验持续时间内遵守该实验的试验方案，包括配合完成该实验需要的任何治疗，检查，检验，随访和调查问卷； 13.患者愿意配合在试验治疗和随访过程完成生活质量的问卷调查，并同意这些问卷调查结果用于临床研究； 14.任何既往的化疗的毒副反应已恢复至≤CTCAE1级或基线水平，除外≤CTCAE2级的症状稳定的感觉神经病变或脱发。

Inclusion criteria

1. Before any procedure can be carried out, an informed consent form must be signed and the form must be filed at the research center. 2. Female patients whose age is 18 or above; 3. Biopsies were obtained through open surgery, laparoscopic surgery, or fine-needle aspiration. The pathological examination confirmed that the lesions were high-grade serous or endometrioid ovarian cancer, peritoneal cancer, or fallopian tube cancer (referred to as ovarian cancer); 4. FIGO stage III-IV; 5. Blood and tissue samples of the patients before, during and after the treatment can be obtained, and the subjects have agreed to hand over the blood and tissue samples to the central laboratory for the expansion research purposes of this trial, including but not limited to: i. possible genetic-related research. ii. possible tumor marker-related research; 6. There is at least one lesion that can be measured by CT/MRI; 7. Believed not suitable for the initial tumor reduction surgery (PDS): (1) Meeting the high-risk perioperative complication criteria of the Mayo standard; (2) If imaging cannot determine whether the tumor is resectable, laparoscopic examination is the preferred option. If the Fagotti score under laparoscopy is >= 8 points, and there is extensive small intestine involvement or mesenteric contracture, and the following conditions are met: 1) Albumin < 3.5 g/dl; 2) Age >= 80 years; 3) Age 75-79 years, and one of the following conditions exists: PS > 1 (ASA 3-4); or stage IV (multiple liver metastases or lung metastases); or complex surgical procedures (exceeding uterus + bilateral ovaries + greater omentum resection); within the past 6 months: VTE; or myocardial infarction; or vascular stent placement; or open surgery. Fagotti score (2 points per item) Large/granular abdominal peritoneal implantation lesions; Greater omentum cake involving the greater curvature of the stomach; Extensive peritoneal infiltrative lesions and/or most of the diaphragmatic surface involved; Mesenteric root involvement; Small intestine/large intestine resection and/or extensive implantation of lesions on the intestine;Tumor infiltration of the gastric wall; Surface lesions on the liver > 2 cm. 8. Expected survival period > 12 weeks; 9. The patient's ECOG score is 0-2; 10. The patient should have good organ functions and meet the following laboratory criteria: (1) Within the last 14 days, without using granulocyte colony-stimulating factor, the absolute neutrophil count (ANC) should be >= 1.5 × 10^9/L. (2) Within the last 14 days, without blood transfusion, the platelet count should be >= 100 × 10^9/L. (3) Within the last 14 days, without blood transfusion or use of erythropoietin, the hemoglobin should be > 9 g/dL; (4) Total bilirubin <= 1.5 × the upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) should be <= 2.5 × ULN (ALT or AST <= 5 × ULN is allowed for patients with liver metastasis); (5) Serum creatinine <= 1.5 × ULN or creatinine clearance rate (using the Cockcroft-Gault formula: CrCL (mL/min) = {(140 - age) × weight (kg) × 0.85} / (SCr (mg/dL) × 72)) >= 50 ml/min; (6) Good coagulation function, defined as the international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN. 11. For women with reproductive potential, the pregnancy test in blood or urine must be negative within one week before enrollment. After enrollment, effective contraceptive measures must be taken, such as using physical barrier contraceptive methods (condoms) or complete abstinence. Oral, injection, or implantation of hormonal contraceptives are not allowed. Or for women without reproductive potential, reproductive potential is defined as: i. naturally entering menopause and having no menstruation for more than one year; ii. surgical sterilization (bilateral oophorectomy, bilateral fallopian tube resection, or hysterectomy); iii. serum follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels within the menopausal standard in the research center laboratory. 12. Understand the test procedures and be capable of adhering to the test plan of the experiment throughout the duration of the test, including cooperating in completing any treatments, examinations, tests, follow-ups and questionnaires required for the experiment; 13. The patient is willing to cooperate in completing the quality of life questionnaire during the trial treatment and follow-up process, and agrees that the results of these questionnaires can be used in clinical research. 14. Any previous chemotherapy-induced toxic or side effects have returned to <= CTCAE grade 1 or the baseline level, excluding stable sensory nerve lesions or hair loss that are <= CTCAE grade 2.

排除标准：

1. 在该项研究进行的同时，使用其他的试验研究药物，参加的其他临床药物实验； 2. 在该项研究进行的同时，使用其他肿瘤新辅助治疗手段，包括但不限于：化疗，放疗，免疫治疗，微生物治疗，中医中药治疗以及其他的试验性疗法； 3.已知对法米替尼/卡度尼利或与其具有相似化学结构药物的活性或非活性成分过敏者； 4.无法吞咽口服药物，以及患有任何可能干扰研究药物吸收代谢的胃肠道疾病，例如，难以控制的恶心和呕吐、消化道梗阻或吸收不良； 5.接受过任何卵巢癌相关抗癌治疗； 6.既往经接受过已知或可能的TKI抑制剂/ICB免疫治疗； 7.需要同时治疗的症状性或非控制性脑转移，包括但不限于手术、放射和/或皮质类固醇，或者有脊髓压迫的临床表现； 8. 研究开始前3周内接受过重大手术，或手术后尚未恢复； 9. 受试者既往3年内存在其他恶性疾病，除外得到有效治疗的皮肤鳞癌、基底样癌，乳腺导管内原位癌或宫颈原位癌。 10.患者有既往或当前诊断的骨髓增生异常综合征（MDS）或急性髓性白血病（AML）； 11.患有严重的、未能控制的疾病或研究者判断受试者一般情况不适合加入研究，包括但不限于：活动性病毒感染如人类免疫缺陷病毒、乙型肝炎、丙型肝炎等；重度心血管疾病、未能控制的室性心率失常、最近3个月内发生过心肌梗塞；未能控制的癫痫大发作、不稳定性脊髓压迫、上腔静脉综合征或其他影响患者签署知情同意的精神疾患；经药物不能控制的高血压；免疫缺陷（除外脾切除）或其它研究者认为有可能使患者暴露于高风险毒性的疾病； 12.任何病史或现存的临床证据表明可能存在混淆研究结果、干扰患者在整个研究治疗期间的遵守试验方案或不符合患者最佳利益的情况； 13.患者在研究药物开始治疗前的3天内接受过血小板或红细胞输注； 14.怀孕或哺乳、或预期在研究治疗期间计划怀孕的患者。 15. 临床存在未解决的既往治疗毒性（≥2级，除外脱发、神经痛、淋巴细胞减少、皮肤色素脱失）。

Exclusion criteria：

1. Concurrently with this research, other experimental drugs were used and other clinical drug trials were participated in; 2. Concurrent with this research, other neoadjuvant treatment methods for tumors were employed, including but not limited to: chemotherapy, radiotherapy, immunotherapy, microbiological treatment, traditional Chinese medicine treatment, and other experimental therapies; 3. Individuals known to be allergic to famitinib/cadonil or to the active or inactive components of drugs with similar chemical structures to them; 4. Unable to take oral medications, and having any gastrointestinal disorders that may interfere with the absorption and metabolism of the study drugs, such as uncontrollable nausea and vomiting, digestive tract obstruction, or malabsorption; 5. Has received any cancer treatment related to ovarian cancer; 6. Has previously received known or potential TKI inhibitors/ICB immunotherapy; 7. Symptomatic or uncontrolled brain metastases that require concurrent treatment, including but not limited to surgery, radiotherapy and/or corticosteroids, or clinical manifestations of spinal cord compression; 8. Those who had undergone major surgery within the previous 3 weeks, or who were still not recovered after the surgery; 9. The subjects had other malignant diseases within the past 3 years, except for skin squamous cell carcinoma, basaloid carcinoma, intraductal carcinoma of the breast, or cervical carcinoma in situ that had been effectively treated. 10. The patient has a previous or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); 11. Subjects with severe and uncontrolled diseases or those whose general condition, as determined by the researchers, is not suitable for participation in the study, including but not limited to: active viral infections such as human immunodeficiency virus, hepatitis B, hepatitis C; severe cardiovascular diseases, uncontrolled ventricular arrhythmias, myocardial infarction within the last 3 months; uncontrolled epileptic seizures, unstable spinal cord compression, superior vena cava syndrome or other mental disorders that affect the subject's ability to sign the informed consent; uncontrolled hypertension; immunodeficiency (except for splenectomy) or other diseases that the researchers consider may expose the subject to high-risk toxicities; 12. Any past medical history or current clinical evidence indicates the possibility of confusion in the research results, interference with the patient's compliance with the trial protocol throughout the entire treatment period, or deviation from the patient's best interests. 13. The patient had received platelet or red blood cell transfusions within 3 days prior to starting the treatment with the investigational drug; 14. Patients who are pregnant or breastfeeding, or who plan to become pregnant during the course of the study treatment. 15. There is unresolved previous treatment toxicity in the clinical setting (>= grade 2, excluding hair loss, neuralgia, lymphocyte reduction, and skin depigmentation).

研究实施时间：

Study execute time：

从 From 2026-02-15 00:00:00至 To 2028-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-02-15 00:00:00 至 To 2028-12-31 00:00:00  

干预措施：

Interventions：

组别：

试验组B

样本量：

22

Group：

Group B

Sample size：

干预措施：

指南推荐的标准化疗方案（如紫杉醇+卡铂）

干预措施代码：

Intervention：

Control Arm: Guideline-Recommended Standard Chemotherapy (Paclitaxel + Carboplatin)

Intervention code：

组别：

试验组A

样本量：

44

Group：

Group A

Sample size：

干预措施：

卡度尼利单抗、法米替尼联合卡铂单药化疗组

干预措施代码：

Intervention：

Experimental Arm: Cadonilimab + Famitinib + Carboplatin

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 

市(区县)：

  

Country：

China 

Province：

Shanghai 

City：

 

单位(医院)：

上海交通大学医学院附属新华医院 

单位级别：

三级甲等 

Institution
hospital：

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

生物指标

指标类型：

附加指标

Outcome：

biomarkers

Type：

Additional indicator

测量时间点：

治疗三个周期后

测量方法：

治疗过程中血液及肿瘤免疫相关因子及细胞的变化检测，筛选预测卡度尼利单抗、法米替尼联合化疗作为新辅助治疗有效性的生物指标。

Measure time point of outcome：

After three cycles of treatment

Measure method：

Changes in immune-related factors and immune cell populations in blood and tumor tissue during treatment will be evaluated to identify biomarkers predictive of the efficacy of cadonilimab combined with famitinib and chemotherapy as neoadjuvant therapy.

指标中文名：

R0手术切除率

指标类型：

主要指标

Outcome：

R0

Type：

Primary indicator

测量时间点：

治疗三个周期后

测量方法：

R0手术切除率根据术后病理及手术记录进行评估，定义为无肉眼及显微残留病灶。

Measure time point of outcome：

After three cycles of treatment

Measure method：

The R0 resection rate will be assessed based on surgical records and postoperative pathological evaluation, defined as no macroscopic or microscopic residual disease.

指标中文名：

病理缓解率（pCR）

指标类型：

次要指标

Outcome：

Pathological complete response (pCR)

Type：

Secondary indicator

测量时间点：

治疗三个周期后

测量方法：

新辅助治疗前后肿瘤组织病理检查及免疫组化指标PD-L1 CPS评分等检测

Measure time point of outcome：

After three cycles of treatment

Measure method：

Tumor tissue pathological examination and immunohistochemical indicators such as PD-L1 CPS score before and after neoadjuvant therapy were detected.

指标中文名：

客观缓解率（ORR）

指标类型：

次要指标

Outcome：

Objective response rate

Type：

Secondary indicator

测量时间点：

治疗三个周期后

测量方法：

新辅助治疗前和治疗后盆腹腔MRI评估肿瘤侵犯范围、是否有肿块及肿块大小、淋巴结及其他脏器转移情况等；新辅助治疗前和治疗后血肿瘤标志物检测HE4、CA125、CA199等；

Measure time point of outcome：

After three cycles of treatment

Measure method：

Before and after neoadjuvant therapy, pelvic and abdominal MRI was used to assess the extent of tumor invasion, the presence of masses and their sizes, lymph node and other organ metastasis conditions, etc.; before and after neoadjuvant therapy, blood tumor markers such as HE4, CA125, and CA199 were detected.

指标中文名：

无进展生存期和总生存期

指标类型：

次要指标

Outcome：

Progression-free survival and overall survival

Type：

Secondary indicator

测量时间点：

治疗3 个月、6 个月、12 个月、36个月后评估

测量方法：

新辅助治疗后患者6个月/1年/3年/中位无疾病生存期PFS， 1年/3年/中位总生存期OS

Measure time point of outcome：

Assessments will be performed at 3, 6, 12 and 36 months after initiation of treatment.

Measure method：

The patient's 6-month/1-year/3-year/median disease-free survival (PFS) after neoadjuvant treatment, and the 1-year/3-year/median overall survival (OS)

指标中文名：

安全性

指标类型：

主要指标

Outcome：

safety

Type：

Primary indicator

测量时间点：

治疗三个周期后

测量方法：

新辅助治疗后患者治疗相关不良事件（TRAEs）发生情况登记

Measure time point of outcome：

After three cycles of treatment

Measure method：

Registration of treatment-related adverse events (TRAEs) in patients after neoadjuvant therapy

指标中文名：

生活质量

指标类型：

次要指标

Outcome：

quality of life

Type：

Secondary indicator

测量时间点：

治疗三个周期后

测量方法：

新辅助治疗后患者生活质量评分表

Measure time point of outcome：

After three cycles of treatment

Measure method：

Quality of Life Score Sheet for Patients after Neoadjuvant Therapy

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

腹水

组织：

Sample Name：

ascites

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：

肿瘤组织及淋巴结

组织：

Sample Name：

tumor and lymph node

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

采用中央随机化系统对受试者进行随机化入组，中央随机化系统由上海交通大学医学院生物统计学系提供。采用区组随机化进行随机化分组，块大小将设置为6。

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

Subjects were randomized using a centralized randomization system, which was provided by the Department of Biostatistics, Shanghai JiaoTong University School of Medicine. Block randomization was employed for group allocation, with the block size set to 6.

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

Blinding：

Open-label study

是否共享原始数据：

IPD sharing

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）：

本试验不公开原始数据。

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

non available

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：

本研究采用电子数据采集系统（EDC）进行临床研究数据的采集与管理。所有研究数据均来源于原始病历、检查记录及实验室报告，并如实、及时、完整地录入电子病例报告表（eCRF）。研究者负责原始文件的填写与保存，确保数据真实、准确、可追溯。eCRF 中的数据修改须按照系统要求记录修改原因，确保数据质量与研究规范性。

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

This study will use an electronic data capture (EDC) system for the collection and management of clinical trial data. All study data will be derived from source documents, including original medical records, examination records, and laboratory reports, and will be entered into the electronic case report forms (eCRFs) in a timely, accurate, complete, and truthful manner. Investigators are responsible for the completion and retention of all source documents to ensure data authenticity, accuracy, and traceability. Any modifications to eCRF data must be performed in accordance with system requirements, with the reasons for data changes clearly documented to ensure data quality and compliance.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-01-28 16:23:05