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注册号： Registration number：	ChiCTR2400086577
最近更新日期： Date of Last Refreshed on：	2024-07-05 14:44:17
注册时间： Date of Registration：	2024-07-05 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	阿得贝利单抗联合化疗和阿帕替尼围术期治疗肺肉瘤样癌的开放标签、单臂、多中心、II期临床研究
Public title：	The efficacy and safety study of adebrelimab in combination with chemotherapy and apatinib for perioperative treatment of lung sarcomatoid carcinoma
注册题目简写：
English Acronym：
研究课题的正式科学名称：	阿得贝利单抗联合化疗和阿帕替尼围术期治疗肺肉瘤样癌的开放标签、单臂、多中心、II期临床研究
Scientific title：	The efficacy and safety study of adebrelimab in combination with chemotherapy and apatinib for perioperative treatment of lung sarcomatoid carcinoma
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：	陈军	研究负责人：	陈军
Applicant：	Jun Chen	Study leader：	Jun Chen
申请注册联系人电话： Applicant telephone：	+86 158 2219 2921	研究负责人电话： Study leader's telephone：	+86 158 2219 2921
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：	huntercj2004@qq.com	研究负责人电子邮件： Study leader's E-mail：	huntercj2004@qq.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：	天津市和平区鞍山道154号	研究负责人通讯地址：	天津市和平区鞍山道154号
Applicant address：	154 Anshan Road, Heping District, Tianjin, China	Study leader's address：	154 Anshan Road, Heping District, Tianjin, 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：	天津医科大学总医院
Applicant's institution：	Tianjin Medical University General Hospital
研究负责人所在单位：	天津医科大学总医院
Affiliation of the Leader：	Tianjin Medical University General Hospital

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：	IRB2024-YX-110-01	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：	天津医科大学总医院医学伦理委员会
Name of the ethic committee：	Ethics Committee of Tianjin Medical University General Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2024-03-28 00:00:00
伦理委员会联系人：	金冬来
Contact Name of the ethic committee：	Donglai Jin
伦理委员会联系地址：	天津市和平区鞍山道154号
Contact Address of the ethic committee：	154 Anshan Road, Heping District, Tianjin
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 22 6036 1044	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：

天津医科大学总医院

Primary sponsor：

Tianjin Medical University General Hospital

研究实施负责（组长）单位地址：

天津市和平区鞍山道154号

Primary sponsor's address：

154 Anshan Road, Heping District, Tianjin, 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)：	天津	市(区县)：	天津
Country：	China	Province：	Tianjin	City：	Tianjin
单位(医院)：	天津医科大学总医院	具体地址：	天津市和平区鞍山道154号
Institution hospital：	Tianjin Medical University General Hospital	Address：	No.154 Anshan Road, Tianjin, China

经费或物资来源：

江苏恒瑞医药股份有限公司

Source(s) of funding：

Jiangsu Hengrui Medicine Co.,Ltd.

Target disease：

pulmonary sarcomatoid carcinoma

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：

探索阿得贝利单抗联合化疗和阿帕替尼围术期治疗肺肉瘤样癌的有效性和安全性

Objectives of Study：

The efficacy and safety study of adebrelimab in combination with chemotherapy and apatinib for perioperative treatment of lung sarcomatoid carcinoma

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.年龄 ≥ 18岁且 ≤ 75岁； 2.经组织学证实的不能手术的肺肉瘤样癌，或可手术切除肺肉瘤样癌患者（按照WHO肺肉瘤样癌标准，病理标本中包含有梭形和/或巨细胞、多形性癌、巨细胞癌、癌肉瘤、肺母细胞瘤成份）如果患者活检样本中诊断为非小细胞肺癌伴肉瘤样成份，肉瘤样成分肿瘤细胞可以是梭形细胞，和/或巨细胞胞和/或异源性肉瘤分化，包括横纹肌肉瘤，软骨肉瘤等，也可纳入； 3.排除MET基因14号外显子跳跃突变的患者； 4.既往未接受过针对PSC肿瘤的免疫抑制剂和抗血管治疗； 5.东部肿瘤协作组（ECOG）体能状态评分为0或1； 6.按照RECIST 1.1标准，患者须至少具有一个可测量病灶； 7.须提供足够的诊断为肺肉瘤样癌的肿瘤组织样本（穿刺活检/新鲜/蜡包埋），以及治疗期间血液样本，用以进行生物标记物探索，包括但不限于PD-L1免疫组化染色、NGS检测； 8.受试者须具有足够的肺功能，用于预期的肺切除手术； 9.造血功能良好，其定义为中性粒细胞绝对计数 ≥ 1.5×109/L，血小板计数 ≥ 100×109/L，血红蛋白 ≥ 90g/L [7日内无输血或无促红细胞生成素依赖性]； 10.肝功能良好，定义为总胆红素水平 ≤ 1.5倍正常上限（ULN）；不存在肝转移的患者，谷草转氨酶（AST）和谷丙转氨酶（ALT）水平 ≤ 2.5倍ULN；有记录到肝脏转移的患者，AST和ALT水平 ≤ 5倍ULN； 11.肾功能良好，定义为血清肌酐 ≤ 1.5倍ULN或计算得出的肌酐清除率 ≥ 60 ml/min（Cockcroft-Gault 公式）；尿常规检查尿蛋白少于2+，如患者在基线水平的尿蛋白 ≥ 2+时应收集24小时尿液并证明24小时尿蛋白定量检测 ≤ 1g； 12.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；若受试者正接受抗凝治疗，只要PT在抗凝药物拟定的使用范围内即可； 13.对于有生育能力的女性受试者，应在接受首次试验药物给药（第1周期，第1天）之前的七天内进行血清妊娠试验，且结果为阴性。 14.受试者须同意在试验期间和末次给予试验药物后90天内采用有效的方法避孕或已手术绝育； 15.能够依从研究和随访程序；在任何试验相关流程实施之前，签署书面知情同意。

Inclusion criteria

1. Age ≥ 18 years and ≤ 75 years; 2. Histologically proven inoperable pulmonary sarcomatoid carcinoma, or patients with surgically resectable pulmonary sarcomatoid carcinoma (according to the WHO criteria for pulmonary sarcomatoid carcinoma, pathology specimens containing spindle and/or giant cells, pleomorphic carcinoma, giant cell carcinoma, carcinosarcoma, and pneumoblastoma components) If the patient has a diagnosis of non-small-cell lung carcinoma with a sarcomatoid component in the biopsy sample, the tumor cells of the sarcomatoid component may be spindle, and/or giant cellular and/or heterologous sarcoma differentiation, including rhabdomyosarcoma, chondrosarcoma, and so forth, may be included; and or giant cells and/or heterologous sarcomatous differentiation, including rhabdomyosarcoma, chondrosarcoma, etc., may also be included; 3. Exclude patients with exon 14 jump mutations in the MET gene; 4. No prior immunosuppressive and antivascular therapy against PSC tumors; 5. Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1; 6. Patients must have at least one measurable lesion according to RECIST 1.1 criteria; 7. Must provide sufficient tumor tissue samples (puncture biopsy/fresh/wax-embedded) with a diagnosis of pulmonary sarcomatoid carcinoma, as well as blood samples during treatment for biomarker exploration including, but not limited to, PD-L1 immunohistochemical staining, and NGS testing; 8. Subjects must have adequate lung function for the anticipated lung resection; 9. Good hematopoietic function, defined as absolute neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, and hemoglobin ≥ 90g/L [no transfusion or no erythropoietin dependence within 7 days]; 10. Good hepatic function, defined as total bilirubin level ≤ 1.5 times the upper limit of normal (ULN); albumin transaminase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times the ULN in patients with no hepatic metastases; AST and ALT levels ≤ 5 times the ULN in patients with documented hepatic metastases; 11. Good renal function, defined as serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula); urine protein of less than 2+ on routine urinalysis, or if the patient has urinary protein of ≥ 2+ at baseline level 24-hour urine should be collected and demonstrated to be ≤ 1g on a 24-hour quantitative urine protein test; 12. Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times the ULN; if the subject is receiving anticoagulation therapy, as long as the PT is within the range of use of anticoagulant medication proposed; 13. For female subjects of childbearing potential, a serum pregnancy test shall be performed within seven days prior to receiving the first test drug administration (Cycle 1, Day 1) with a negative result. 14. Subjects must agree to use an effective method of contraception or have been surgically sterilized for the duration of the trial and for 90 days after the last administration of the test drug; 15. Be able to comply with study and follow-up procedures; 16. Signed written informed consent prior to the implementation of any trial-related processes.

排除标准：

1.既往使用过抗 PD-1、抗 PD-L1、抗程序性死亡受体配体 2（PD-L2）或抗细胞毒 T 淋巴细胞相关抗原 4（CTLA-4）药物或作用于T细胞协同刺激或检查点通路的任何其它药物（如OX40、CD137等）、既往使用过抗血管生成药物的患者； 2.影像学（CT或MRI）显示证实肿瘤侵犯大血管或与血管分界不清，首次用药前1个月内，单次咯血量 ≥ 2.5mL； 3.存在MET基因14号外显子跳跃突变的患者； 4.伴有活动性出血或穿孔或存在的遗传性或获得性出血倾向； 5.患有高血压病，经降压药物治疗无法降至正常范围者（收缩压 ≤ 140 mmHg /舒张压 ≤ 90mmHg）； 6.尿常规提示尿蛋白 ≥ (++) ，且24小时尿蛋白量 ≥ 1.0g； 7.存在血栓形成疾病，需要使用华法林或肝素长期抗凝治疗，或需要长期抗血小板治疗（阿司匹林 ≥ 300 mg/天或氯吡格雷 ≥ 75 mg/天）； 8.具有影响口服药物吸收的多种因素，如无法吞咽、恶心呕吐、慢性腹泻和肠梗阻等； 9.在筛选期间和放射影像学评估之前，通过CT或MRI评估确认有症状性、未治疗或积极进展的中枢神经系统（CNS）转移。但只要同时满足以下所有条件，有稳定的CNS病灶且经过治疗的无症状患者也可入组： ①根据RECIST v1.1确定的可测量病灶必须存在于CNS之外； ②患者无颅内出血或脊髓出血史； ③患者在开始研究治疗前7天内未进行立体定向放射治疗，在开始研究治疗前14天内未进行全脑放射治疗，或在开始研究治疗前28天内未进行神经外科切除术； ④入组前影像证实已稳定至少4周，且已停止全身性激素治疗（剂量≤10mg/天泼尼松或其他等效激素）大于2周； ⑤转移限于小脑或幕上区（即，没有转移至中脑、脑桥、髓质或脊髓）； 10.当前正在参与干预性临床研究治疗，或在首次给药前4周内接受过其他研究药物或使用过研究器械治疗； 11.接受过实体脏器或血液系统移植； 12.首次给药前2年内发生过需要全身性治疗（例如使用缓解疾病药物、皮质类固醇或免疫抑制剂）的活动性自身性免疫疾病。替代疗法（例如甲状腺素、胰岛素或者用于肾上腺或垂体机能不全的生理性皮质类固醇等）不视为全身性治； 13.诊断为免疫缺陷或研究首次给药前7天内正在接受全身性糖皮质激素治疗或任何其他形式的免疫抑制疗法；允许使用生理剂量的糖皮质激素(≤ 10 mg/天的强的松或等效药物）； 14.首次给药前1年内存在需要糖皮质激素治疗的非感染性肺炎病史或当前存在间质性肺疾病； 15.患有Ⅱ级以上心肌缺血或心肌梗塞、控制不良的心律失常的受试者（包括QTc 间期男性 ≥ 450 ms、女性 ≥ 470 ms）。按照NYHA标准Ⅲ~Ⅳ级心功能不全或心脏彩超检查：LVEF（左室射血分数＜50%的受试者）； 16.已知有人类免疫缺陷病毒（HIV）感染史； 17.未经治疗的活动性乙型肝炎；注：符合下列标准的乙肝受试者也可不排除： a.首次给药前 HBV 病毒载量必须＜1000 拷贝/ml（200 IU/ml），受试者应在整个研究药物治疗期间接受抗 HBV 治疗避免病毒再激活； b.对于抗 HBc（+）、HBsAg（-）、抗 HBs（-）和 HBV 病毒载量（-）的受试者，不需要接受预防性抗 HBV治疗，但是需要密切监测病毒再激活； 18.活动性的HCV感染受试者（HCV抗体阳性且HCV-RNA水平高于检测下限）； 19.首次用药前4周内发生过严重感染的受试者，包括但不局限于需要住院治疗的感染并发症，菌血症，重症肺炎等；排除伴有任何活动性感染的受试者；不排除肺癌淋巴扩散的情况； 20.孕妇和哺乳期妇女； 21.已知对阿得贝利单抗注射液，甲磺酸阿帕替尼片或其任何辅料过敏； 22.在入组前5年内患有NSCLC以外的恶性肿瘤，除外充分治疗的宫颈原位癌、基底细胞或鳞状上皮细胞皮肤癌、根治术后的局部前列腺癌、根治术后的导管原位癌。经研究者判断，受试者有其他可能导致本研究被迫中途终止的因素。

Exclusion criteria：

1. Patients with prior use of anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) drugs, or any other drugs acting on T-cell co-stimulation or checkpoint pathways (e.g., OX40, CD137, etc.), or prior use of anti-angiogenic drugs; 2. Imaging (CT or MRI) showing confirmed tumor invasion of large blood vessels or poor demarcation from blood vessels, and a single hemoptysis ≥ 2.5mL within 1 month prior to the first dose; 3. Patients with exon 14 jump mutation of MET gene; 4. With active bleeding or perforation or the presence of hereditary or acquired bleeding tendency; 5. Patients with hypertension who cannot be reduced to the normal range (systolic blood pressure ≤ 140 mmHg / diastolic blood pressure ≤ 90 mmHg) by antihypertensive drug treatment; 6. Urine routine suggests that urinary protein ≥ (++), and the amount of urinary protein in 24 hours ≥ 1.0g; 7. Presence of thrombotic diseases requiring long-term anticoagulation with warfarin or heparin, or long-term antiplatelet therapy (aspirin ≥ 300 mg/day or clopidogrel ≥ 75 mg/day); 8. Have multiple factors that interfere with the absorption of oral medications, such as inability to swallow, nausea and vomiting, chronic diarrhea, and intestinal obstruction 9. Have symptomatic, untreated or actively progressing central nervous system (CNS) metastases confirmed by CT or MRI evaluation during screening and prior to radiologic imaging evaluation. However, asymptomatic patients with stable CNS lesions that have been treated may also be enrolled as long as all of the following conditions are also met: (i) Measurable lesions identified according to RECIST v1.1 must exist outside the CNS; (ii) Patients have no history of intracranial or spinal cord hemorrhage; (iii) Patients have not had stereotactic radiation therapy within 7 days prior to initiation of study treatment, whole brain radiation therapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment; ④ Imaging confirmation of stabilization for at least 4 weeks prior to enrollment and cessation of systemic hormone therapy (dose ≤ 10 mg/day prednisone or other equivalent hormone) for > 2 weeks; ⑤ Metastases are limited to the cerebellum or supratentorial region (i.e., no metastases to the midbrain, pons, medulla, or spinal cord); 10. Currently participating in an interventional clinical study treatment or have received other investigational drugs or have been treated with an investigational device within 4 weeks prior to the first dose; 11. Has received a solid organ or blood system transplant; 12. Active autoimmune disease requiring systemic therapy (e.g., use of disease-mitigating drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroids used for adrenal or pituitary insufficiency, etc.) are not considered systemic therapy; 13. Diagnosis of immunodeficiency or ongoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study; physiologic doses of glucocorticoids (≤ 10 mg/day of prednisone or equivalent) are allowed; 14. Have history of non-infectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year prior to the first dose of glucocorticoid therapy 15. Subjects with grade II or greater myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc intervals ≥ 450 ms in men and ≥ 470 ms in women). Subjects with grade III-IV cardiac insufficiency according to NYHA criteria or cardiac ultrasound: LVEF (left ventricular ejection fraction <50%); 16. Known history of human immunodeficiency virus (HIV) infection; 17. Untreated active hepatitis B; Note: Hepatitis B subjects meeting the following criteria may also be excluded: a. HBV viral load must be <1000 copies/ml (200 IU/ml) prior to the first dose of study drug, and subjects should receive anti-HBV therapy to avoid viral reactivation throughout the duration of study drug therapy; b. For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required but close monitoring of viral reactivation is necessary; 18. Subjects with active HCV infection (HCV antibody positive and HCV-RNA levels above the lower limit of detection); 19. Subjects who have had a serious infection within 4 weeks prior to the first dose, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc.; subjects with any concomitant active infection are excluded; lymphatic spread of lung cancer is not excluded; 20. Pregnant and lactating women; 21. Known hypersensitivity to adebelizumab injection, apatinib mesylate tablets or any of its excipients; 22. Malignancy other than NSCLC within 5 years prior to enrollment, except adequately treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery. Subjects who, in the judgment of the investigator, have other factors that may have forced the mid-term termination of this study.

研究实施时间：

Study execute time：

从 From 2024-04-01 00:00:00至 To 2027-04-01 00:00:00

征募观察对象时间：

Recruiting time：

从From 2024-07-05 00:00:00 至 To 2025-07-01 00:00:00

干预措施：

Interventions：

组别：	实验组	样本量：	25
Group：	experimental group	Sample size：	25
干预措施：	手术前新辅助治疗阶段 1.阿得贝利单抗：1200 mg静脉滴注，D1，Q3W，治疗2-4个周期； 2.阿帕替尼：250 mg，QD，餐后半小时服用，治疗2-4个周期； 3.白蛋白紫杉醇：260 mg/m2，D1，Q3W； 4.顺铂：70 mg/m2，D1，Q3W（不超过130 mg）/卡铂：300-400 mg/m2，D1，Q3W。化疗在手术前后可拆分给药，总共治疗不超过4周期。新辅助末次用药6周内进行手术，术后6周内经研究者评估进行辅助治疗。手术后辅助治疗阶段，由研究者决定治疗方案（驱动基因阴性患者推荐阿得贝利单抗1200 mg + 阿帕替尼250 mg，最长不超过13个周期；驱动基因阳性患者由研究者选择TKIs辅助治疗）。	干预措施代码：
Intervention：	Pre-surgical neoadjuvant therapy phase 1.Adebrelimab: 1200 mg IV, D1, Q3W, treatment for 2-4 cycles; 2. Apatinib: 250 mg, QD, half hour after meal, treatment for 2-4 cycles; 3. albumin paclitaxel: 260 mg/m2, D1, Q3W; 4. cisplatin: 70 mg/m2, D1, Q3W (no more than 130 mg)/carboplatin: 300-400 mg/m2, D1, Q3W. Chemotherapy may be given in split doses before and after surgery for a total of no more than 4 cycles of treatment. Surgery was performed within 6 weeks of the last neoadjuvant dose, and adjuvant therapy was administered within 6 weeks after surgery as assessed by the investigator. Post-surgical adjuvant therapy phase. Treatment regimen determined by the investigator (Adebrelimab1200 mg + apatinib 250 mg for up to 13 cycles is recommended for driver gene-negative patients; adjuvant treatment with TKIs is selected by the investigator for driver gene-positive patients).	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	Tianjin	市(区县)：	Tianjin
Country：	China	Province：	Tianjin	City：	Tianjin
单位(医院)：	天津医科大学总医院	单位级别：	三甲
Institution hospital：	Tianjin Medical University General Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	内蒙古自治区	市(区县)：
Country：	China	Province：	Inner Mongolia Autonomous Region	City：
单位(医院)：	内蒙古医科大学附属医院	单位级别：	三甲
Institution hospital：	The Affiliated Hospital of Inner Mongolia Medical University	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	河北	市(区县)：
Country：	China	Province：	Hebei	City：
单位(医院)：	河北医科大学第四医院	单位级别：	三甲
Institution hospital：	The Fourth Hospital of Hebei Medical University	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	陕西	市(区县)：
Country：	China	Province：	Shanxi	City：
单位(医院)：	西安交通大学第一附属医院	单位级别：	三甲
Institution hospital：	First Affiliated Hospital of Xi'an Jiaotong University	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	四川	市(区县)：
Country：	China	Province：	Sichuan	City：
单位(医院)：	四川大学华西医院	单位级别：	三甲
Institution hospital：	West China Hospital, Sichuan University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	病理完全病理缓解率	指标类型：	主要指标
Outcome：	Pathological complete remission rate	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	手术转化率	指标类型：	次要指标
Outcome：	The surgical conversion 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：	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：	主要病理缓解率	指标类型：	次要指标
Outcome：	Major pathological response after	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：	无病生存期	指标类型：	次要指标
Outcome：	Disease-Free Survival	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	无事件生存期	指标类型：	次要指标
Outcome：	Event-Free Survival	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：	组织	组织：
Sample Name：	tissue	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	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:

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	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）：	医朵云
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	https://www.edocyun.com.cn/#home-service
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
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：	2024-07-05 14:43:59