ChiCTR2500099104 版本V1.0 版本创建时间2025/03/18 16:22:45 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：

 ChiCTR2500099104 

最近更新日期：

Date of Last Refreshed on：

 2025-03-18 16:22:39 

注册时间：

Date of Registration：

 2025-03-18 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

依沃西单抗联合含铂双药化疗一线治疗局部晚期或转移性SMARCA4缺失型非小细胞肺癌的有效性和安全性的II期临床研究

Public title：

A phase II clinical study of the efficacy and safety of ivoximab in combination with platinum-doublet chemotherapy in the first-line treatment of locally advanced or metastatic SMARCA4 deletion non-small cell lung cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

依沃西单抗联合含铂双药化疗一线治疗局部晚期或转移性SMARCA4缺失型非小细胞肺癌的有效性和安全性的II期临床研究

Scientific title：

A phase II clinical study of the efficacy and safety of ivoximab in combination with platinum-doublet chemotherapy in the first-line treatment of locally advanced or metastatic SMARCA4 deletion non-small cell lung 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：

梁媛 

研究负责人：

梁媛 

Applicant：

Yuan Liang 

Study leader：

Yuan Liang 

申请注册联系人电话：

Applicant telephone：

 +86 18900917786

研究负责人电话：

Study leader's
telephone：

+86 24 81916363

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：

 cmuliangyuan@163.com

研究负责人电子邮件：

Study leader's E-mail：

 cmuliangyuan@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：

辽宁省沈阳市大东区小河沿路44号

研究负责人通讯地址：

沈阳市大东区小河沿路44号

Applicant address：

No.44 Xiaoheyan Road, Dadong District, Shenyang 10042, Liaoning Province

Study leader's address：

No.44 Xiaoheyan Road, Dadong District, Shenyang City, Liaoning Province. 110042, P.R.C

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：

辽宁省肿瘤医院(辽宁省肿瘤研究所)

Applicant's institution：

Liaoning Provincial Cancer Hospital (Liaoning Provincial Cancer Institute)

研究负责人所在单位：

辽宁省肿瘤医院（辽宁省肿瘤研究所）

Affiliation of the Leader：

Liaoning Provincial Cancer Hospital (Liaoning Provincial Cancer Institute)

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：

 20241270

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：

辽宁省肿瘤医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Liaoning Cancer Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-12-19 00:00:00

伦理委员会联系人：

李爽

Contact Name of the ethic committee：

Shuang Li

伦理委员会联系地址：

沈阳市大东区小河沿路44号

Contact Address of the ethic committee：

No. 44, Xiaoheyan Road, Dadong District, Shenyang City

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 24 31916632

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 524236007@qq.com

研究实施负责（组长）单位：

辽宁省肿瘤医院（辽宁省肿瘤研究所）

Primary sponsor：

Liaoning Provincial Cancer Hospital (Liaoning Provincial Cancer Institute)

研究实施负责（组长）单位地址：

沈阳市大东区小河沿路44号

Primary sponsor's address：

No. 44, Xiaoheyan Road, Dadong District, Shenyang City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

辽宁

市(区县)：

Country：

China

Province：

Liaoning

City：

单位(医院)：

辽宁省肿瘤医院（辽宁省肿瘤研究所）

具体地址：

沈阳市大东区小河沿路44号

Institution
hospital：

Liaoning Provincial Cancer Hospital (Liaoning Provincial Cancer Institute)

Address：

No. 44, Xiaoheyan Road, Dadong District, Shenyang City

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-selected project (self-funded)

研究疾病：

SMARCA4缺陷型非小细胞肺癌  

Target disease：

SMARCA4 deficient non-small cell lung cancer, SMARCA4-dNSCLC

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：

 II期临床试验 

Study phase：

2

研究设计：

单臂 

Study design：

Single arm 

研究目的：

主要目的： 评估依沃西单抗联合含铂双药化疗一线治疗局部晚期或转移性SMARCA4缺失型非小细胞肺癌的有效性； 次要目的： 评估依沃西单抗联合含铂双药化疗一线治疗局部晚期或转移性SMARCA4缺失型非小细胞肺癌的安全性；  

Objectives of Study：

Primary Objectives: To evaluate the effectiveness of combined ivonescimab and platinum-based chemotherapy as first-line treatment for locally advanced or metastatic SMARCA4-deficient non-small cell lung cancer patients. Secondary Objectives: To evaluate the safety of combined ivonescimab and platinum-based chemotherapy as first-line treatment for locally advanced or metastatic SMARCA4-deficient non-small cell lung cancer patients.

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.自愿加入本研究，签署知情同意书； 2.年龄：18-75岁，男女不限； 3.经组织病理学或细胞病理学确诊病理类型为SMARCA4缺失型NSCLC，按照国际肺癌研究协会（IASLC）第九版分期标准诊断为IIIB-IV期，即局部晚期（须是经研究者评估其肿瘤病灶已不能手术或放疗根治）或转移； 4.ECOG身体状况评分0-1； 5.具有可测量的肿瘤靶病灶（满足RECIST 1.1标准）； 6.预期生存期> 3个月； 7.通过以下要求确定良好的器官功能：血液学（开始研究治疗前7天内未使用任何血液成分及细胞生长因子支持治疗):中性粒细胞绝对值ANC >= 1.5 ×10^9/L (1,500/mm3) ;血小板计数 >=100 × 10^9/L (100,000/mm^3) ；血红蛋白 >=90 g/L。 肾脏： 肌酐清除率* (CrCl) 计算值 >=50 mL/min 将采用 Cockcroft-Gault 公式计算 CrCl CrCl (mL/min) = {(140 - 年龄) × 体重 (kg) × F}/ (SCr (mg/dL) × 72) 其中男性的 F = 1，女性的 F = 0.85；SCr = 血清肌酐。尿蛋白 < 2+ 或24小时（h）尿蛋白定量 < 1.0 g。肝脏： 血清总胆红素（TBil） <=1.5 × ULN AST和ALT <=2.5× ULN，对于肝转移的受试者，AST和ALT可 <= 5×ULN 血清白蛋白（ALB）>=28 g/L d) 凝血功能：国际标准化比率（INR）和活化部分凝血活酶时间（APTT） <= 1.5 × ULN。 心功能:左室射血分数（LVEF）>=50%。 8.具有生育能力的女性受试者必须在首次用药前3天内进行尿液或血清妊娠检查（如尿液妊娠检查结果不能确认为阴性，需进行血清妊娠检查，以血清妊娠结果为准），且结果为阴性。

Inclusion criteria

1. Voluntarily join this study and sign the informed consent form; 2. Age: 18-75 years old, male or female; 3. Confirmed pathological type of SMARCA4 deletion NSCLC by histopathology or cytopathology, and diagnosed as stage IIIB-IV according to the International Association for the Study of Lung Cancer (IASLC) 9th edition staging criteria, that is, locally advanced (the tumor lesion must be assessed by the investigator to be inoperable or radiotherapy) or metastasis; 4. ECOG physical condition score 0-1; 5. Have measurable tumor target lesions (meet RECIST 1.1 criteria); 6. Expected survival> 3 months; 7. Good organ function as determined by the following requirements: hematology (no use of any blood components and cell growth factor supportive therapy within 7 days prior to initiation of study treatment): absolute neutrophil ANC > = 1.5 ×10^9/L (1,500/mm3); Platelet count >=100 × 10^9/L (100,000/mm^3); Hemoglobin >=90 g/L. Renal: Creatinine clearance* (CrCl) calculated >=50 mL/min CrCl will be calculated using the Cockcroft-Gault formula CrCl (mL/min) = {(140 - age) × weight (kg) × F}/ (SCr (mg/dL) × 72) where F = 1 for males and F = 0.85 for females; SCr = serum creatinine. Urine protein < 2 or 24 hours (h) urine protein quantification < 1.0 g. Liver: Serum total bilirubin (TBil) <=1.5 × ULN AST and ALT <=2.5× ULN, for subjects with liver metastases, AST and ALT can be < = 5×ULN Serum albumin (ALB) >=28 g/L d) Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) < = 1.5 × ULN. Cardiac function: left ventricular ejection fraction (LVEF) >=50%. 8. Female subjects of childbearing potential must have a urine or serum pregnancy test within 3 days before the first dose (if the urine pregnancy test result cannot be confirmed to be negative, a serum pregnancy test is required, and the serum pregnancy result shall prevail) and the result is negative.

排除标准：

1. 除NSCLC以外，受试者在入组前3年内患有其他恶性肿瘤。 2. 同时入组另一项临床研究，除非其为一项观察性、非干预性的临床研究或干预性研究的随访； 3. 既往接受过系统性抗肿瘤治疗； 4. 首次给药前2周内针对非靶病灶进行了姑息性局部治疗；首次给药前2周内接受过非特异性免疫调节治疗（如白介素、干扰素、胸腺肽、肿瘤坏死因子等，不包括用于治疗血小板减少的IL-11）；首次给药前1周内曾接受具有抗肿瘤适应症的中草药或中成药； 5. 患有在过去两年内需要系统性治疗的活动性自身免疫性疾病（如使用改善病情药物、皮质类固醇、免疫抑制剂治疗）。替代治疗（如甲状腺素、胰岛素、或针对肾上腺或垂体功能不全的生理性皮质类固醇替代治疗）不认为是一种系统性治疗； 6. 活动性或既往有明确的炎症性肠病（如克罗恩病、溃疡性结肠炎或慢性腹泻）病史。 7. 存在免疫缺陷病史；HIV抗体检测阳性者；当前正在长期使用系统性皮质类固醇激素或其他免疫抑制剂。 8. 已知存在活动性肺结核（TB），怀疑有活动性TB的受试者，需进行临床检查排除；已知的活动性梅毒感染。 9. 已知异体器官移植史和异体造血干细胞移植史。 10.存在需要系统性糖皮质激素治疗的非感染性肺炎/间质性肺疾病病史或当前存在非感染性肺炎。 11.首次给药前4周内发生严重感染，包括但不局限于伴有需要住院治疗的合并症、败血症或严重肺炎；在首次给药前两周内接受过全身抗感染治疗的活动性感染（不包括乙型肝炎或丙型肝炎的抗病毒治疗）。 12.未经治疗的活动性乙型肝炎受试者（HBsAg阳性且HBV-DNA超过1000拷贝/ml（200 IU/ml）或高于正常范围上限），对于患有乙型肝炎的受试者，要求在研究治疗期间接受抗乙肝病毒治疗；活动性的丙型肝炎受试者（HCV抗体阳性且HCV-RNA水平高于检测下限）。 13.在首次给药前30天内进行过重大外科手术或发生严重外伤，或在首次给药后的30天内有重大外科手术计划者（由研究者决定）；在首次给药前3天内进行过较小的局部手术（不包括经外周静脉穿刺中心静脉置管术和静脉输液港植入术）。 14.存在脑干、脑膜转移、脊髓转移或压迫。 15.存在活动性中枢神经系统（CNS）转移病灶；先前治疗过的脑转移的受试者（如手术、放疗），如果治疗后临床稳定至少两周（从首次给予研究药物开始起计算），且研究药物给药前3天停用皮质类固醇激素，则允许入组；未经治疗的、无症状的脑转移受试者(即无神经系统症状，不需要皮质类固醇激素，没有任何脑转移灶的长径>1.5 cm，无明显脑转移灶周围水肿)可以入组。 16.肿瘤侵犯周围重要脏器（如主动脉、心脏及心包、上腔静脉、气管、食管等）或存在发生食管气管瘘或食管胸膜瘘风险。 17.存在有临床症状或需要引流的胸腔积液、心包积液或腹水的受试者。 18.当前存在未得到控制的合并疾病，包括但不限于症状性充血性心力衰竭（按照纽约心脏病协会功能分级确定的2级及以上）、不稳定型心绞痛、急性心肌缺血、控制不佳的心律失常、失代偿性肝硬化、肾病综合征、未控制的代谢紊乱、重度活动性消化性溃疡病或胃炎，或会限制受试者依从研究要求或影响受试者提供书面知情同意能力的精神疾病/社会状况。 19.既往存在心肌炎、心肌病、恶性心律失常病史。首次给药前12个月内存在需住院治疗的不稳定性心绞痛、心肌梗塞、充血性心力衰竭或血管疾病（如存在破裂风险的主动脉瘤），或可能影响研究药物安全性评价的其他心脏损害（如控制不佳的心律失常，心肌缺血等）；首次给药前6个月内存在食管胃底静脉曲张，严重溃疡，伤口未愈，胃肠穿孔，腹瘘，胃肠梗阻，腹腔内脓肿或急性胃肠道出血病史；首次给药前6个月内发生过任何动脉血栓栓塞事件，NCI CTCAE 5.0版3级及以上的静脉血栓栓塞事件，短暂性脑缺血发作，脑血管意外，高血压危象或高血压脑病；首次给药前1个月内发生慢性阻塞性肺病急性加重；当前存在高血压且经口服降压药物治疗后收缩压>=160mmHg或舒张压>=100mmHg。 20.有严重出血倾向或凝血功能障碍病史；首次给药前1个月内存在具有显著临床意义的出血症状，包括但不限于消化道出血、咳血（定义为咳出或咯出≥1茶匙鲜血或小血块或只咳血无痰液，允许痰中带血者入组）、鼻腔出血（不包括鼻衄出血及回缩性涕血）；筛选期影像学显示肿瘤包绕重要血管或存在明显坏死、空洞，且研究者判定进入研究会引起出血风险；中央型、存在空洞的鳞状NSCLC且研究者判断出血风险较高；首次给药前10天内接受过持续的抗血小板或抗凝治疗。 21.既往抗肿瘤治疗毒性未缓解，定义为毒性未恢复至NCI CTCAE 5.0版0级或1级，或入选/排除标准中规定的水平，但脱发除外。对于发生不可逆毒性且预期研究药物给药后不会加重的受试者（例如听力损失），在与医学监查员协商后，可能会被纳入研究。放疗引起的远期毒性，经研究者判断不能恢复的受试者，在与医学监查员协商后，可能会被纳入研究。 22.在首次给药前的30天内接种了活疫苗，或计划在研究期间接种活疫苗。 23.已知对任何研究药物的任何成分过敏；已知对其他单克隆抗体产生严重超敏反应的病史。 24.已知有精神疾病、药物滥用、酗酒或吸毒史。 25.妊娠期或哺乳期女性。 26.既往或当前存在任何疾病、治疗、实验室检查异常，可能会混淆研究结果，影响受试者全程参与研究，或参与研究可能不符合受试者的最佳利益。 27.非恶性肿瘤导致的局部或全身性疾病，或肿瘤继发的疾病或症状，并可导致较高医学风险和/或生存期评价的不确定性，如肿瘤类白血病反应（白细胞计数>20×10^9 / L）、恶液质表现（如已知的筛选前3个月体重减轻超过10%）等。

Exclusion criteria：

1.Diagnosis of malignant diseases other than NSCLC within 3 years prior to the first dose; 2.Currently participating in interventional clinical research treatment; 3.Previously received systemic antitumor therapy; 4.Palliative local treatment of nontarget lesions was administered within 2 weeks before the first dose;received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 for thrombocytopenia) within 2 weeks before the first dose;Received proprietary Chinese medicines with anti-lung cancer indications drugs within 1 week before the first administration; 5.An active autoimmune disease requiring systemic treatment has occurred within 2 years prior to initial administration; 6.Active or prior history of a definite inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea). 7.Diagnosis of immunodeficiency;Known history of human immunodeficiency virus (HIV) infection; Currently receiving systemic glucocorticoid therapy or other immunosuppressive agents; 8.Known active pulmonary tuberculosis (TB);Clinical examination should be excluded in patients with suspected active TB; Known active syphilis infection. 9.History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 10.History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease; 11.Active infection requiring systemic therapy; 12.Untreated subjects with active hepatitis B (HBsag-positive and HBV-DNA of more than 1000 copies per milliliter (200 IU per milliliter) or above the upper limit of the normal range) and, for those with hepatitis B, were required to receive anti-HBV therapy for the duration of the study treatment; Subjects with active hepatitis C (positive for HCV antibodies and HCV-RNA levels above the lower limit of detection). 13.Had undergone a major surgical procedure or major trauma within 30 days before or within 30 days after the first dose (at the discretion of the investigator); Minor local procedures (excluding peripherally inserted central catheters and implantation of venous-access ports) had been performed within 3 days before the first dose; 14.Present brain stem, meningeal metastases, spinal cord metastases, or compression; 15.Known active CNS metastases; Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 2?weeks, are clinically stable and have not required steroid treatment for at least 3?days before the first dose of study intervention; asymptomatic brain metastases were allowed; 16.Tumor invades the surrounding important organs (such as aorta, heart and pericardium, superior vena cava, trachea, esophagus, etc.) or there is a risk of esophagotracheal fistula or esophagopleural fistula; 17.Clinically uncontrollable pleural effusion/abdominal/pericardial effusion; 18.The presence of any uncontrolled systemic disease,including but not limited to symptomatic congestive heart failure (New York Heart Association functional class 2 or higher), unstable angina, acute myocardial ischemia, uncontrolled arrhythmia, decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease, or gastritis;mental illness/social condition that would limit compliance with study requirements or affect the participant's ability to provide written informed consent. 19.History of myocarditis, cardiomyopathy, and malignant arrhythmia. Unstable angina, myocardial infarction, congestive heart failure, or vascular disease requiring hospitalization (e.g., aortic aneurysm with risk of rupture), or other cardiac damage (e.g., poorly controlled arrhythmia, myocardial ischemia, etc.) that may affect the safety evaluation of the study drug, had been reported within 12 months before the first dose of the study drug. The patient had a history of esophagogastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months before the first dose of medication. Any arterial thromboembolic event, venous thromboembolic event of NCI CTCAE version 5.0 or higher, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy occurred within 6 months before the first dose of dose. An acute exacerbation of chronic obstructive pulmonary disease occurred within 1 month before the first dose. Current hypertension with systolic blood pressure >=160mmHg or diastolic blood pressure >=100mmHg treated with oral antihypertensive drugs; 20.History of severe bleeding or coagulopathy; Clinically significant bleeding symptoms within 1 month before the first dose of medication, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or coughing up ≥1 teaspoon of blood or small blood clot or only coughing up blood without sputum, and those with blood in sputum were allowed), nasal bleeding (excluding epistaxis and retraction of nasal bleeding); During the screening period, imaging showed that the tumor was surrounded by important blood vessels or had obvious necrosis or cavity, and the investigators judged that the risk of bleeding would be caused by entering the study. Central squamous NSCLC with cavity and high risk of bleeding according to the investigator's judgment; Continuous antiplatelet or anticoagulant therapy had been administered within 10 days before the first dose; 21.Adverse reactions caused by previous treatment did not recover to CTCAE (version 5.0) grade 1 and below; or not to levels specified in the inclusion/exclusion criteria; Except for hair loss. Long-term, can not recover and does not increase the safety risk may be enrolled after consultation with the medical monitor. 22.Received a live vaccine within 30?days before the first dose of study intervention or plan to receive live vaccine during the study; 23.Known allergy to any component of any study drug; A history of severe hypersensitivity reactions to other monoclonal antibodies was known. 24.Known history of mental illness, substance abuse, alcohol or drug abuse; 25.Pregnant or lactating women; 26.History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant’s ability to cooperate with the requirements of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator. 27.Local or systemic disease that is not caused by malignancy, or disease or symptoms secondary to malignancy, which may lead to high medical risk and/or uncertainty in the evaluation of survival, such as tumor leukemoid reaction (white blood cell count >20×10^9 / L), cachexia (such as known weight loss of > 10% within 3 months before screening), etc.

研究实施时间：

Study execute time：

从 From 2025-03-01 00:00:00至 To 2027-03-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-03-19 00:00:00 至 To 2027-02-28 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 20

Group：

Experimental group

Sample size：

干预措施：

依沃西单抗： 20mg/kg，Q3W。以 60 分钟（+/-10 分钟）静脉输注给药。对于无法耐受60 分钟输注的受试者，输注时间最长可延长至 120 分钟。治疗期间依沃西单抗不允许进行剂量调整，但允许延迟给药，延迟给药最长 12 周（自上一次给药时间计算），如果出现因治疗 irAE应用糖皮质激素，糖皮质激素减量过程导致依沃西单抗暂停用药超过 12 周或因治疗与依沃西单抗可能无关或无关的 AE，导致依沃西单抗暂停用药超过 12 周这两种情况，且研究者判断患者能从继续治疗中获益，这种情况下可允许继续用药。

干预措施代码：

Intervention：

Ivoximab: 20 mg/kg, q3 W Administered as a 60-minute (/-10 min) intravenous infusion. For subjects who are unable to tolerate the 60-minute infusion, the infusion time can be extended to a maximum of 120 minutes. Dose adjustment is not allowed for ivoximab during the treatment period, but delayed dosing is permitted for up to 12 weeks (from the time of the last dose), in which case continued medication may be allowed if there are glucocorticoids for the treatment of irAEs, the glucocorticoid tapering process that results in the suspension of ivoximab for more than 12 weeks, or the treatment of an AE that may be unrelated or unrelated to ivoximab and which results in the suspension of ivoximab for more than 12 weeks, and the investigator determines that the patient would benefit from continued treatment.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 辽宁 

市(区县)：

  

Country：

China

Province：

Liaoning

City：

单位(医院)：

 辽宁省肿瘤医院（辽宁省肿瘤研究所） 

单位级别：

 三级甲等 

Institution
hospital：

Liaoning Provincial Cancer Hospital (Liaoning Provincial Cancer Institute)

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

无进展生存期

指标类型：

主要指标

Outcome：

Progress Free Survival

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

指标类型：

次要指标

Outcome：

Adverse event

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生活质量评估

指标类型：

次要指标

Outcome：

Quality of Life Assessment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

客观缓解率

指标类型：

次要指标

Outcome：

Objective Response Rate

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：

Disease Control Rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

缓解持续时间

指标类型：

次要指标

Outcome：

Durationg of relief

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

至缓解时间

指标类型：

次要指标

Outcome：

Time to Response

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

总生存期

指标类型：

次要指标

Outcome：

Overall Survival

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：

无

组织：

Sample Name：

None

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 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:

不公开/Private

盲法：

无

Blinding：

None

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：

CRF;EDC

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

CRF,;EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-03-18 16:22:39