ChiCTR2500097924 版本V1.0 版本创建时间2025/02/27 11:58:09 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：

ChiCTR2500097924 

最近更新日期：

Date of Last Refreshed on：

2025-02-27 11:57:48 

注册时间：

Date of Registration：

2025-02-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

阿得贝利单抗联合阿帕替尼辅助治疗切除术后高复发风险的肝细胞癌患者的一项单臂、探索性研究

Public title：

A single arm, exploratory study on the combination of Adebrelimab and Apatinib as adjuvant therapy for hepatocellular carcinoma patients at high risk of recurrence after resection surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

阿得贝利单抗联合阿帕替尼辅助治疗切除术后高复发风险的肝细胞癌患者的一项单臂、探索性研究

Scientific title：

A single arm, exploratory study on the combination of Adebrelimab and Apatinib as adjuvant therapy for hepatocellular carcinoma patients at high risk of recurrence after resection surgery

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：

李涛 

研究负责人：

李涛 

Applicant：

Li Tao 

Study leader：

Li Tao 

申请注册联系人电话：

Applicant telephone：

+86 17660088880

研究负责人电话：

Study leader's telephone：

+86 18560085138

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：

litao@126.com

研究负责人电子邮件：

Study leader's E-mail：

litao7706@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：

山东省济南市历下区文化西路107号

研究负责人通讯地址：

文化西路107号齐鲁医院

Applicant address：

No. 107 Wenhua West Road, Lixia District, Jinan City, Shandong Province

Study leader's address：

Qilu Hospital, 107 Wenhua West Road

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：

山东大学齐鲁医院

Applicant's institution：

Qilu Hospital of Shandong University

研究负责人所在单位：

山东大学齐鲁医院

Affiliation of the Leader：

Qilu Hospital of Shandong University

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：

KYLL-202401-002-1

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：

山东大学齐鲁医院科研伦理委员会

Name of the ethic committee：

Research Ethics Committee of Qilu Hospital, Shandong University

伦理委员会批准日期：

Date of approved by ethic committee：

2024-03-26 00:00:00

伦理委员会联系人：

卜丽娟

Contact Name of the ethic committee：

Bu Lijuan

伦理委员会联系地址：

文化西路107号齐鲁医院

Contact Address of the ethic committee：

Qilu Hospital, 107 Wenhua West Road

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 531 82169166

伦理委员会联系人邮箱：

Contact email of the ethic committee：

bulijuan16@sdu.edu.cn

研究实施负责（组长）单位：

山东大学齐鲁医院

Primary sponsor：

Qilu Hospital of Shandong University

研究实施负责（组长）单位地址：

文化西路107号齐鲁医院

Primary sponsor's address：

Qilu Hospital, 107 Wenhua West Road

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

山东

市(区县)：

Country：

China

Province：

Shandong

City：

单位(医院)：

山东大学齐鲁医院

具体地址：

文化西路107号齐鲁医院

Institution
hospital：

Qilu Hospital of Shandong University

Address：

Qilu Hospital, 107 Wenhua West Road

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self selected topic (self funded)

Target disease：

Hepatocellular carcinoma with high risk of recurrence after resection surgery

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 上市后药物 

Study phase：

4

研究设计：

单臂 

Study design：

Single arm 

研究目的：

到目前为止，尚无前瞻性研究探索PD-L1抑制剂联合抗血管生成小分子TKI方案应用于HCC患者术后辅助治疗的疗效和安全性。因此，本中心拟开展一项前瞻性临床研究，针对术后高复发风险的HCC患者，论证阿得贝利单抗联合阿帕替尼术后辅助治疗的疗效和安全性。  

Objectives of Study：

So far, there have been no prospective studies exploring the efficacy and safety of PD-L1 inhibitors combined with anti angiogenic small molecule TKIs for postoperative adjuvant therapy in HCC patients. Therefore, our center plans to conduct a prospective clinical study to demonstrate the efficacy and safety of adjunctive treatment with atezolizumab combined with apatinib in HCC patients at high risk of postoperative recurrence.

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.自愿参加本研究，签署知情同意书。
2.年龄≥18周岁，男女皆可。
3.经病理组织学/细胞学确诊为HCC或根据《原发性肝癌诊疗规范（2022年版）》临床诊断为HCC的受试者。
4.入组前 4-12 周内接受了根治性切除术。
5.入组前 4 周内从手术切除中完全恢复。
6.具有切除术后肝细胞癌复发的高风险因素（肿瘤多发、肿瘤长径＞5cm、肿瘤分化差（Edmondson III-IV级）、切缘≤1cm、微血管或大血管侵犯、淋巴结转移、肿瘤标志物AFP或异常凝血酶原（DCP）持续异常等）。
7.入组前7天内Child-Pugh肝功能评级：A级或B级（≤7分）。
8.入组前7天内ECOG PS评分：0-1分。
9.既往未接受过针对肝细胞癌的系统性抗肿瘤治疗。
10.预期生存时间≥12周。
11.主要器官功能符合下列要求（在入组前7天内）： （1）血常规检查：（除外血红蛋白，筛查前14天内未输血、未使用粒细胞集落刺激因子[G-CSF]、未使用药物纠正）： ?中性粒细胞绝对计数≥1.5×10^9/L； ?血小板≥75×10^9/L； ?血红蛋白≥90g/L。 （由脾功能亢进引起的白细胞、血小板减少经脾动脉部分栓塞或药物纠正后可以入组） （2）血生化检查（筛查前14天内未输白蛋白）： ?血清白蛋白≥28g/L； ?血清总胆红素≤1.5×ULN； ?ALT和AST≤3×ULN； ?血肌酐≤1.5×ULN或Cr清除率＞50ml/min （3）国际标准化比率（INR）≤2.3或凝血酶原时间（PT）超过正常对照的范围≤6秒； （4）尿蛋白<2+（若尿蛋白≥2+,须进行24小时（h）尿蛋白定量，24h尿蛋白定量<1.0g可以入组）。
12.若患有乙型肝炎病毒（HBV）感染，需愿意在研究期间全程接受抗病毒治疗（依据诊疗指南标准进行治疗，例如恩替卡韦）并定期监测；丙型肝炎病毒（HCV）核糖核酸（RNA） 阳性受试者必须按诊疗指南接受抗病毒治疗且肝功能在CTCAE1 级升高以内。
13.有生育能力的女性：必须同意从签署知情同意书开始直到研究药物末次用药后90天（以较长者计算）期间避孕。且在开始研究治疗前的7天内血HCG检查必须为阴性；而且必须为非哺乳期。

Inclusion criteria

1. Voluntarily participate in this study and sign an informed consent form. 2. Age >= 18 years old, both male and female are eligible. 3. Subjects diagnosed with HCC through histopathology/cytology or clinically diagnosed with HCC according to the "Diagnosis and Treatment Guidelines for Primary Liver Cancer (2022 Edition)". 4. Radical resection was performed within 4-12 weeks prior to enrollment. 5. Complete recovery from surgical resection within 4 weeks prior to enrollment. 6. High risk factors for recurrence of hepatocellular carcinoma after resection surgery (multiple tumors, tumor length>5cm, poor tumor differentiation (Edmondson III-IV grade), resection margin <= 1cm, microvascular or macrovascular invasion, lymph node metastasis, persistent abnormal tumor markers AFP or abnormal prothrombin (DCP), etc.). 7. Child Pugh within 7 days prior to enrollment: A or B (<= 7 ). 8. ECOG PS score within 7 days before enrollment: 0-1; 9. Have not received systematic anti-tumor treatment for hepatocellular carcinoma in the past. 10. Expected survival time >= 12 weeks. 11. The main organ functions meet the following requirements (within 7 days before enrollment): (1) Blood routine examination: (excluding hemoglobin, no blood transfusion within 14 days before screening, no use of granulocyte colony-stimulating factor [G-CSF], no medication correction): Absolute neutrophil count >= 1.5 × 10 ^ 9/L; Platelets >= 75 × 10 ^ 9/L; Hemoglobin >= 90g/L. (Leukopenia and thrombocytopenia caused by splenic hyperfunction can be included in the study after partial splenic artery embolization or drug correction.) (2) Blood biochemistry test (no albumin transfusion within 14 days before screening): Serum albumin <= 28g/L; Serum total bilirubin <= 1.5 × ULN; ALT and AST <= 3 × ULN; Blood creatinine <= 1.5 × ULN or Cr clearance rate>50ml/min (3) International normalized ratio (INR) <= 2.3 or prothrombin time (PT) exceeding the normal control range <= 6 seconds; (4) Urinary protein<2+(If urinary protein is >= 2+, 24-hour (h) urine protein quantification must be performed, and 24-hour urine protein quantification<1.0g can be included in the group). 12. If suffering from hepatitis B virus (HBV) infection, one must be willing to receive antiviral treatment throughout the study period (according to diagnostic and treatment guidelines, such as entecavir) and regularly monitor; Hepatitis C virus (HCV) ribonucleic acid (RNA) positive subjects must receive antiviral treatment according to diagnostic and treatment guidelines and have liver function within CTCAE1 level elevation. 13.Women with fertility must agree to contraception from the time of signing the informed consent form until 90 days (whichever is longer) after the last use of the study drug. And the blood HCG test must be negative within 7 days before starting the study treatment; And it must be non lactating.

排除标准：

1.已知肝胆管细胞癌、肉瘤样肝细胞癌、肝混合细胞癌及纤维板层细胞癌；5年内或同时患有除肝细胞癌之外的其它活动性恶性肿瘤（已治愈的皮肤基底细胞癌和宫颈原位癌除外）。
2.存在不可控的肝外转移，如肺、脑转移（EHS）。
3.既往接受过局部治疗，包括治疗性TACE、经动脉栓塞（TAE）、肝动脉灌注化疗（HAIC）、经动脉放射性栓塞（TARE）等。
4.准备进行或者既往接受过器官或同种异基因骨髓移植的受试者。
5.目前伴有间质性肺炎或间质性肺病，或既往有需激素治疗的间质性肺炎或间质性肺病病史者，或其他可能干扰免疫相关肺毒性判断和处理的肺纤维化、机化性肺炎（例如，闭塞性细支气管炎）、尘肺、药物相关肺炎、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或肺功能严重受损的受试者，允许放射野曾有辐射性肺炎；活动性结核。
6.目前存在活动性自身免疫病或有自身免疫病病史且可能复发（包括但不局限于：自身免疫性肝炎、间质性肺炎、葡萄膜炎、肠炎、垂体炎、血管炎、肾炎、甲状腺功能亢进、甲状腺功能降低[仅通过激素替代治疗可以控制的受试者可纳入]）；受试者患有无需系统治疗的皮肤病如白癜风、银屑病、脱发，接受胰岛素治疗的经控制的 I型糖尿病或在童年期哮喘已完全缓解，成人后无需任何干预的可纳入；需要支气管扩张剂进行医学干预的哮喘受试者则不能纳入。
7.患有高血压，且经降压药物治疗无法获得良好控制（收缩压≥140mmHg或者舒张压≥90mmHg）（基于≥2次测量获得的BP读数的平均值），允许通过使用降压治疗实现上述参数；既往曾出现高血压危象或高血压性脑病。
8.有临床症状的中度、重度腹水即需要治疗性的穿刺、引流者或Child-Pugh评分>2（仅影像学显示少量腹水但不伴有临床症状者除外）；不受控制或中等量及以上的胸腔积液、心包积液。
9.有未能良好控制的心脏临床症状或疾病，如：（1）按照纽约心脏病协会（NYHA）标准II级以上心脏功能不全或心脏彩超检查：LVEF（左室射血分数）<50%；（2）不稳定型心绞痛；（3）研究治疗开始前1年内发生过心肌梗死；（4）有临床意义的室上性或室性心律失常需要治疗或干预；（5）QTc> 480ms（QTc 间期以Fridericia公式计算；若QTc异常，可间隔2分钟连续检测三次，取其平均值）。
10.自发性肝脏肿瘤破裂史。
11.有肝性脑病病史者。
12.受试者先天或后天免疫功能缺陷（如HIV感染者）。
13.研究治疗开始前6个月内发生过血栓形成或栓塞事件，例如脑血管意外（包括短暂性脑缺血发作、脑出血、脑梗塞）、肺栓塞等。
14.研究治疗开始前6个月内有消化道出血病史或具有明确的胃肠道出血倾向，如：有出血风险的或重度食管胃底静脉曲张、有局部活动性消化道溃疡病灶、持续大便潜血阳性不可入组（基线期若大便潜血阳性，需复查，复查后若仍为阳性，需要进行胃十二指肠镜检（EGD），若EGD提示出血风险的食管胃底静脉曲张/其他消化道疾病均不能入组）。
15.研究治疗开始前6个月内出现过腹部瘘管、胃肠道穿孔或腹腔脓肿。
16.严重、未愈合或裂开的伤口以及活动期溃疡或未经治疗的骨折。
17.已知存在的遗传性或获得性出血（如凝血功能障碍）或血栓倾向， 如血友病病人；目前正在或近期（研究治疗开始前10天内）曾出于治疗目的使用全剂量口服或注射抗凝药物或溶栓药物（允许预防性使用小剂量阿司匹林、低分子肝素）。
18.在研究治疗开始前6个月内出现重大血管疾病（例如，需要手术修补或近期有外周动脉血栓形成的主动脉瘤）。
19.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；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受试者有资格参与研究）。
20.已知对本研究的研究药物（阿得贝利单抗、阿帕替尼）所含的活性成分、辅料有超敏反应，或曾对任何其他单克隆抗体、抗血管生成靶向药物有严重过敏史。
21.在开始研究治疗之前14天内使用免疫抑制剂或全身激素治疗以达到免疫抑制目的（剂量>10mg/天泼尼松或其他等疗效激素）。
22.在开始研究治疗之前28天内接受过减毒活疫苗治疗，或预期于阿得贝利单抗治疗期间或阿得贝利单抗末次给药后60天内需要接种此类疫苗。
23.在开始研究治疗之前28天或5个半衰期（以时间长者为准）内接受过其他试验用药物治疗。
24.经研究者判断，受试者有其他可能影响研究结果或导致本研究被迫中途终止的因素，如酗酒、药物滥用、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。

Exclusion criteria：

1. Known hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, hepatic mixed cell carcinoma, and fibrolamellar cell carcinoma; Within 5 years or simultaneously with other active malignant tumors other than hepatocellular carcinoma (excluding cured skin basal cell carcinoma and cervical carcinoma in situ). 2. There are uncontrollable extrahepatic metastases, such as lung and brain metastases (EHS). 3. Previously received local treatments, including therapeutic TACE, transarterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC), transarterial radioembolization (TARE), etc. 4. Subjects who are preparing for or have previously undergone organ or allogeneic bone marrow transplantation. 5. For subjects who currently have interstitial pneumonia or interstitial lung disease, or have a history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or other pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or have evidence of active pneumonia or severe lung function impairment on chest computed tomography (CT) images during screening, radiation pneumonitis in the radiation field is allowed; Active tuberculosis. 6. Currently present with active autoimmune diseases or a history of autoimmune diseases that may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects that can only be controlled through hormone replacement therapy may be included]); Subjects with skin diseases that do not need systematic treatment, such as vitiligo, psoriasis, alopecia, controlled type I diabetes that receive insulin treatment, or childhood asthma that has completely alleviated without any intervention after adulthood can be included; Asthma subjects who require bronchodilators for medical intervention cannot be included. 7. Suffering from hypertension and unable to achieve good control with antihypertensive medication (systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90mmHg) (based on the average of BP readings obtained from >= 2 measurements), it is allowed to achieve the above parameters through antihypertensive treatment; Previously experienced hypertensive crisis or hypertensive encephalopathy. 8.Moderate or severe ascites with clinical symptoms that require therapeutic puncture, drainage, or a Child Pugh score>2 (excluding those with only a small amount of ascites on imaging but no clinical symptoms); Uncontrolled or moderate to severe pleural and pericardial effusion. 9. Clinical symptoms or diseases of the heart that have not been well controlled, such as: (1) heart dysfunction of grade II or above according to the New York Heart Association (NYHA) standards or cardiac ultrasound examination: LVEF (left ventricular ejection fraction)<50%; (2) Unstable angina pectoris; (3) Has experienced a myocardial infarction within one year prior to the start of treatment; (4) Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; (5) QTc>480ms (QTc interval calculated using Fridericia's formula; If QTc is abnormal, it can be detected three times in a row with an interval of 2 minutes, and the average value should be taken. 10. History of spontaneous rupture of liver tumors. 11. Individuals with a history of hepatic encephalopathy. 12. Subjects with congenital or acquired immune dysfunction (such as HIV infected individuals). 13. Research on the occurrence of thrombotic or embolic events within 6 months prior to the start of treatment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc. 14. If there is a history of gastrointestinal bleeding or a clear tendency towards gastrointestinal bleeding within 6 months before the start of treatment, such as severe esophageal and gastric varices with bleeding risk, locally active digestive ulcer lesions, and persistent positive fecal occult blood, they cannot be included in the study (if fecal occult blood is positive in the baseline period, re examination is required, and if it is still positive after re examination, gastric duodenoscopy (EGD) is required. Esophageal and gastric varices/other digestive diseases with bleeding risk indicated by EGD cannot be included in the study). 15.Within 6 months prior to the start of treatment, there has been an occurrence of abdominal fistula, gastrointestinal perforation, or abdominal abscess. 16. Severe, unhealed, or cracked wounds, as well as active ulcers or untreated fractures. 17. Known genetic or acquired bleeding (such as coagulation dysfunction) or thrombophilia tendency, such as in hemophilia patients; Currently or recently (within 10 days before the start of study treatment), full dose oral or injectable anticoagulant or thrombolytic drugs are being used for therapeutic purposes (prophylactic use of low-dose aspirin, low molecular weight heparin is allowed). 18.Significant vascular disease (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) occurred within 6 months prior to the start of the study treatment. 19. Within 4 weeks prior to starting the study treatment, there was a severe infection, including but not limited to hospitalization due to infection, bacteremia, or complications of severe pneumonia; Administer therapeutic antibiotics orally or intravenously within 2 weeks prior to starting the study treatment (subjects who receive prophylactic antibiotics, such as those for preventing urinary tract infections or worsening chronic obstructive pulmonary disease, are eligible to participate in the study). 20. It is known that there is a hypersensitivity reaction to the active ingredients and excipients contained in the investigational drugs (Adebrelimab, Apatinib) in this study, or a history of severe allergies to any other monoclonal antibodies or anti angiogenic targeted drugs. 21. Use immunosuppressive agents or systemic hormone therapy (dose>10mg/day prednisone or other effective hormones) within 14 days before starting the study treatment to achieve immunosuppression. 22. Received attenuated live vaccine treatment within 28 days prior to the start of the study treatment, or expected to receive such vaccine during the period of Adebrelimab treatment or within 60 days after the last dose of Adebrelimab. 23. Received treatment with other investigational drugs within 28 days or 5 half lives (whichever is longer) before starting the study treatment. 24. According to the researchers' assessment, the subjects may have other factors that could affect the research results or lead to the forced termination of this study, such as alcohol abuse, drug abuse, other serious illnesses (including mental illnesses) that require concomitant treatment, serious laboratory test abnormalities, and family or social factors that could affect the safety of the subjects.

研究实施时间：

Study execute time：

从 From 2024-03-26 00:00:00至 To 2028-03-25 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-02-28 00:00:00 至 To 2026-08-31 00:00:00  

干预措施：

Interventions：

组别：

治疗组

样本量：

30

Group：

Treatment group

Sample size：

干预措施：

阿得贝利单抗联合阿帕替尼术后辅助治疗

干预措施代码：

Intervention：

Adebrelimab combined with Apatinib as adjuvant therapy after surgery

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)：

山东大学齐鲁医院 

单位级别：

三级甲等 

Institution
hospital：

Qilu Hospital of Shandong University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

无复发生存期 （RFS）

指标类型：

主要指标

Outcome：

relapse-free survival, RFS

Type：

Primary indicator

测量时间点：

自患者入组后前24周内每6周（42±7天）进行一次，之后每12周（84±7天）进行一次

测量方法：

RECIST 1.1标准

Measure time point of outcome：

Every 6 weekends for the first 24 weeks, and every 12 weekends thereafter

Measure method：

RECIST 1.1 standard

指标中文名：

总生存期（OS）

指标类型：

次要指标

Outcome：

Overall survival, OS

Type：

Secondary indicator

测量时间点：

自患者入组后前24周内每6周（42±7天）进行一次，之后每12周（84±7天）进行一次

测量方法：

RECIST 1.1标准

Measure time point of outcome：

Every 6 weekends for the first 24 weeks, and every 12 weekends thereafter

Measure method：

RECIST 1.1 standard

指标中文名：

复发时间（TTR）

指标类型：

次要指标

Outcome：

Time to recurrence, TTR

Type：

Secondary indicator

测量时间点：

自患者入组后前24周内每6周（42±7天）进行一次，之后每12周（84±7天）进行一次

测量方法：

RECIST 1.1标准

Measure time point of outcome：

Every 6 weekends for the first 24 weeks, and every 12 weekends thereafter

Measure method：

RECIST 1.1 standard

指标中文名：

12 个月和 24 个月的 RFS 率

指标类型：

次要指标

Outcome：

12Y-RFS%；24Y-RFS%

Type：

Secondary indicator

测量时间点：

自患者入组后前24周内每6周（42±7天）进行一次，之后每12周（84±7天）进行一次

测量方法：

RECIST 1.1标准

Measure time point of outcome：

Every 6 weekends for the first 24 weeks, and every 12 weekends thereafter

Measure method：

RECIST 1.1 standard

指标中文名：

12 个月和 24 个月的OS率

指标类型：

次要指标

Outcome：

12Y-OS%；24Y-OS%

Type：

Secondary indicator

测量时间点：

自患者入组后前24周内每6周（42±7天）进行一次，之后每12周（84±7天）进行一次

测量方法：

RECIST 1.1标准

Measure time point of outcome：

Every 6 weekends for the first 24 weeks, and every 12 weekends thereafter

Measure method：

RECIST 1.1 standard

指标中文名：

药物安全性

指标类型：

次要指标

Outcome：

Drug safety

Type：

Secondary indicator

测量时间点：

自患者入组后前24周内每6周（42±7天）进行一次，之后每12周（84±7天）进行一次

测量方法：

CTCAE v5.0标准

Measure time point of outcome：

Every 6 weekends for the first 24 weeks, and every 12 weekends thereafter

Measure method：

CTCAE v5.0

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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：

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:

不公开/Private

盲法：

无

Blinding：

None

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）：

研究数据发布6个月后，联系研究者获取

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

Contact the researcher to obtain the research data 6 months after its release

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：

病例报告表

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：

无/No

注册人：

Name of Registration：

  2025-02-27 11:57:48