中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500105244
最近更新日期： Date of Last Refreshed on：	2025-07-01 10:23:40
注册时间： Date of Registration：	2025-07-01 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	替雷利珠单抗联合放化疗围手术期治疗HER2 阴性局部进展期可切除胃食管结合部（GEJ）腺癌患者前瞻性、单中心、单臂II 期临床研究
Public title：	A prospective,single-center,single-arm phase 2 trail of PReOperative Tislelizumab plus chemoradiotherapy perioperative treatment for locally advanced gastroesophageal junction(GEJ) adenocarcinoma patients with Her-2 negative status.
注册题目简写：
English Acronym：
研究课题的正式科学名称：	替雷利珠单抗联合放化疗围手术期治疗HER2 阴性局部进展期可切除胃食管结合部（GEJ）腺癌患者前瞻性、单中心、单臂II 期临床研究
Scientific title：	A prospective,single-center,single-arm phase 2 trail of PReOperative Tislelizumab plus chemoradiotherapy perioperative treatment for locally advanced gastroesophageal junction(GEJ) adenocarcinoma patients with Her-2 negative status.
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：	孟祥宇	研究负责人：	张涛
Applicant：	Meng Xiangyu	Study leader：	Zhang Tao
申请注册联系人电话： Applicant telephone：	+86 189 0091 8284	研究负责人电话： Study leader's telephone：	+86 189 0091 8058
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：	mengxiangyu@cancerhosp-ln-cmu.com	研究负责人电子邮件： Study leader's E-mail：	zhangtao@cancerhosp-ln-cmu.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：	辽宁省沈阳市大东区小河沿路44号
Applicant address：	44 Xiaohe Yan Road, Dadong District, Shenyang , Liaoning	Study leader's address：	44 Xiaohe Yan Road, Dadong District, Shenyang , Liaoning
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
Applicant's institution：	LIAONING CANCER HOSPITAL & INSTITUTE
研究负责人所在单位：	辽宁省肿瘤医院
Affiliation of the Leader：	LIAONING CANCER HOSPITAL & 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：	20231101	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 & Institute
伦理委员会批准日期： Date of approved by ethic committee：	2023-11-07 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：	辽宁省沈阳市大东区小河沿路44号
Contact Address of the ethic committee：	44 Xiaohe Yan Road, Dadong District, Shenyang , Liaoning
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 24 8191 6632	伦理委员会联系人邮箱： Contact email of the ethic committee：	szlyy315@163.com

研究实施负责（组长）单位：

辽宁省肿瘤医院

Primary sponsor：

LIAONING CANCER HOSPITAL & INSTITUTE

研究实施负责（组长）单位地址：

辽宁省沈阳市大东区小河沿路44号

Primary sponsor's address：

44 Xiaohe Yan Road, Dadong District, Shenyang , Liaoning

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)：	沈阳
Country：	China	Province：	Liaoning	City：	Shenyang
单位(医院)：	辽宁省肿瘤医院	具体地址：	大东区小河沿路44号
Institution hospital：	LIAONING CANCER HOSPITAL & INSTITUTE	Address：	44 Xiaohe Yan Road, Dadong District

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

局部进展期可切除胃食管结合部（GEJ）腺癌

Target disease：

locally advanced gastroesophageal junction(GEJ) adenocarcinoma

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：

旨在评价替雷利珠单抗联合放化疗围手术期治疗用于HER2 阴性局部进展期可切除胃食管结合部（GEJ）腺癌患者的疗效和安全性。

Objectives of Study：

To evaluate the efficacy and safety of Tislelizumab combined with chemoradiotherapy in perioperative treatment of HER2-negative locally advanced resectable gastroesophageal junction (GEJ) adenocarcinoma.

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)	签署知情同意书
2)	年龄≥18 且≤ 75 岁
3)	根据研究者的判断，能够依从研究方案
4)	组织学确认为（由入组中心确认）的GEJ 腺癌（Siewert II-III）
5)	HER2 阴性状态，定义为基于治疗前内镜活检组织，通过当地实验室审查 IHC 评分为 0、1+、经原位杂交（ISH）证实基因未扩增的 IHC2+。
6)	经中心实验室检测为PD-L1评分≥1的患者
7)	就诊时的临床分期：第 8 版 AJCC 分期系统确定的 T3-4aN+M0
-	必须进行食管-胃-十二指肠内窥镜检查
-	建议进行内窥镜超声检查
8)	身体条件和器官功能允许接受相应的手术治疗
9)	东部肿瘤协作组（ECOG）体力状态为 0 或 1
10)	预期生存期≥6 个月
11)	在接受序贯放化疗治疗后疾病未进展
12)	研究治疗开始前 7 天内获得的以下实验室检查结果，定义为具有充分的血液学和器官功能：
a.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）：
i.中性粒细胞绝对计数（ANC）≥1.5×109/L（1500/mm3）；
ii.血小板计数≥100×109/L（100000/mm3）；
iii.血红蛋白≥90g/L；
b. 肾脏：
i.血肌酐≤1.5×ULN
ii.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
c. 肝脏：
i.血清总胆红素（TBiL)≤1.5×ULN；
ii.AST和ALT≤3×ULN；
iii.血清白蛋白（ALB）≥28 g/L；
d. 凝血功能：国际标准化比值（INR）和活化部分凝血活酶时间（APTT）≤1.5×ULN（除非受试者正在接受抗凝剂治疗，并且INR和APTT处在使用抗凝剂治疗的预期范围内）；
e. 心功能：左室射血分数（LVEF）≥ 50%；

13)	育龄期妇女受试者必须在随机前7天内进行血清妊娠试验，结果为阴性，且同意在试验期间和末次给药后5个月内采用可靠有效的方法避孕。对于伴侣为育龄期妇女的男性受试者，必须同意在试验期间和末次给药后5个月内采用可靠有效的方法避孕。哺乳期妇女不能入组。

Inclusion criteria

1) Sign informed consent form
2) Aged >= 18 , <= 75 years old
3) According to the researcher's judgment, they are able to comply with the protocol
4) confirmed by histology (confirmed by enrollment center)GEJ adenocarcinoma  (Siewert II-III)
5) HER2-negative status, defined by IHC2+ with an IHC score of 0, 1+ and unamplified gene confirmed by in situ hybridization (ISH), based on pre-treatment endoscopic biopsy tissue reviewed by a local laboratory.
6) Patients with PD-L1 score >=1 tested by the central laboratory
7) Clinical staging at visit: T3-4aN+M0 determined by the 8th edition AJCC staging system
-Esophageal gastric duodenal endoscopy is necessary
-Suggest performing endoscopic ultrasound examination
8) Physical conditions and organ functions permit the appropriate surgical treatment
9) The physical status of the Eastern tumor collaboration group (ECOG) was 0 or 1
10) Expected survival >=6 months
11) The disease did not progress after receiving sequential chemoradiotherapy
12) The following laboratory test results obtained within 7 days prior to the start of research treatment are defined as having sufficient hematological and organ functions
a. Hematology (no blood components or cell growth factors were used to support treatment within 7 days prior to the start of the study):
i. Absolute neutrophil count (ANC) >= 1.5 × 10^9/L (1500/mm3);
Ii. Platelet count >= 100 × 10^9/L (100000/mm3);
Iii. Hemoglobin >= 90g/L;
b. Kidney:
i. Blood creatinine <= 1.5 x ULN
Ii. creatinine clearance rate * (CrCl) calculated value >= 50 mL/min
*The Cockcroft Fault formula will be used to calculate CrCl
CrCL (mL/min)={(140 age) x body weight (kg) x F}/(SCr (mg/dL) x 72)
Among them, F=1 for males and F=0.85 for females; SCR=serum creatinine
c. Liver:
i. Total serum bilirubin (TBiL)<= 1.5 × ULN;
Ii AST and ALT <= 3 × ULN;
Iii. Serum albumin (ALB) >= 28 g/L;
d. Coagulation function: International standardized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5 x ULN (unless the subject is receiving anticoagulant treatment and INR and APTT are within the expected range of anticoagulant treatment);
e. Cardiac function: Left ventricular ejection fraction (LVEF) >= 50%;
13) Women of childbearing age must undergo a serum pregnancy test within 7 days prior to randomization, with a negative result, and agree to use reliable and effective contraception methods during the trial period and within 5 months after the last dose. For male participants whose partners are women of childbearing age, they must agree to use reliable and effective methods of contraception during the trial period and within 5 months after the last dose. Breastfeeding women are not eligible for enrollment.

排除标准：

1） IV 期（转移性）或研究者判定不能手术切除的胃癌/GEJ 癌 2）既往针对胃癌接受过非手术治疗（例如，放疗、化疗和免疫疗法） 3）筛选前 5 年内有 GC 以外的恶性肿瘤病史，但转移或死亡风险可忽略不计（例如 5 年 OS率>90%）的恶性肿瘤除外，例如经充分治疗的宫颈原位癌、非黑色素瘤皮肤癌、局限性前列腺癌、导管原位癌或 I 期宫颈癌 4）入组时存在心肺功能障碍，通过以下任意一项定义： a) 任何分类的充血性心力衰竭 b) 需要抗心绞痛药物治疗的心绞痛、采用适当的药物未能控制的严重心律失常、严重传导异常或有临床意义的瓣膜病 c) 高风险、未控制的心律失常（即静息时心率>100 次/分的房性心动过速、显著室性心律失常（室性心动过速）或高度房室传导阻滞（二度 2 型房室传导阻滞）或三度房室传导阻滞） d) 与左心室功能不全、心脏心律失常或心肌缺血有关的明显症状（>=2 级） e) 随机前 12 个月内的心肌梗死 f) 未控制的高血压（收缩压>180 mmHg 和/或舒张压>100 mmHg） g) ECG 上有透壁性心肌梗死证据 h) 需要氧气治疗 i) 静息时呼吸困难 5）活动性或有自身免疫性疾病或免疫缺陷病史，包括但不限于重症肌无力、肌炎、自身免疫性肝炎、系统性红斑狼疮、类风湿性关节炎、炎性肠病、抗磷脂抗体综合征、韦格纳肉芽肿、舍格林综合征、格林-巴利综合征或多发性硬化（更详细的自身免疫性疾病和免疫缺陷列表参见方案），以下情况除外：有自身免疫介导的甲状腺功能减退病史，正在接受甲状腺-替代激素治疗的患者可以参加本研究。 a) 接受胰岛素方案治疗的已控制 1 型糖尿病患者可以参加本研究。 b) 仅有皮肤表现的湿疹、银屑病、慢性单纯苔藓或白癜风患者（例如，排除银屑病关节炎患者），如果符合以下所有条件，可以参加本研究。 —皮疹覆盖体表面积必须＜10% —疾病在基线时得到良好控制，仅需要低强度外用皮质类固醇 —在过去 12 个月内没有发生需要补骨脂素加紫外线 A 辐射、甲氨蝶呤、维 A 酸、生物制剂、口服钙调磷酸酶抑制剂或高-强度或口服皮质类固醇的基础疾病急性加重。 6）特发性肺纤维化、机化性肺炎（例如闭塞性细支气管炎）、药物诱导性肺炎、特发性肺炎病史或筛选胸部 CT 扫描显示活动性肺炎证据，照射野有放射性肺炎（纤维化）病史的患者可参加本研究。 7）活动性肺结核 8）在开始研究治疗前 4 周内进行过除诊断目的以外的大手术，或预期在研究期间中需要进行大手术 9）在开始研究治疗前 4 周内发生过重度感染，包括但不限于因感染、菌血症或重度肺炎的并发症住院 10）在开始研究治疗前 2 周内（IV 抗生素）或 5 天内（口服抗生素）接受治疗性抗生素治疗  —接受预防性抗生素治疗（例如，预防尿路感染或慢性阻塞性肺病恶化）的患者可以参加本研究。 11）既往接受过同种异体干细胞移植或实体器官移植 12）禁忌使用研究药物、可能影响结果的解释、或使患者处于治疗并发症的高风险的其他任何疾病、代谢功能障碍、体格检查结果或临床实验室检查结果 13）在开始研究治疗前 4 周内接种减毒活疫苗，或预期在替雷利珠单抗治疗期间或在替雷利珠单抗末次给药后 5 个月内需要接种此类疫苗 14）目前接受 HBV 抗病毒治疗 15） HIV 检测阳性 16）活动性乙型肝炎患者（定义为筛选时乙型肝炎表面抗原-HBsAg检测结果呈阳性） a) 既往 HBV 感染或已痊愈的 HBV 感染（定义为 HBsAg 检测阴性或乙型肝炎核心抗原 b) 抗-HBc抗体阳性，在筛选时 HBV-DNA 检测结果为阴性）的患者可以入选 17）活动性丙型肝炎患者 a) HCV 抗体阳性患者仅当 HCV RNA 的 PCR 结果呈阴性时符合条件。 18）存在可能影响方案依从性或结果解释的严重、未控制伴随疾病的证据，包括严重的肝脏疾病（如肝硬化、未控制的癫痫大发作或上腔静脉综合征） 19）在开始治疗研究治疗前 5 个半衰期接受过任何已批准的抗肿瘤治疗 20）在开始研究治疗前 28 天内接受过试验性治疗 21）既往接受过 CD137 激动剂或免疫检查点阻断治疗，包括抗CTLA-4、抗PD-1 和抗PD-L1 治疗性抗体 22）在开始研究治疗前 4 周或药物的 5 个半衰期内（以时间较短者为准）接受过系统性免疫刺激剂（包括但不限于干扰素或白介素-2）治疗 23）在开始研究治疗前 2 周内，接受过系统性免疫抑制药物（包括但不限于泼尼松、环磷酰胺、硫唑嘌呤、甲氨蝶呤、沙利度胺和抗肿瘤坏死因子-α(TNF-α)药物）治疗 a) 接受过急性、低剂量、系统性免疫抑制药物治疗（例如，治疗恶心的单次地塞米松给药）的患者，在与医学监查员讨论并批准后可入组本研究。 24）已知对替雷利珠单抗制剂的任何成分过敏 25）在选择接受替吉奥（S-1）治疗的患者中，已知二氢嘧啶脱氢酶（DPD）缺乏或对氟嘧啶治疗有重度和非预期反应史 26）对口服药物吸收有显著影响，如不能吞咽、慢性泄泻和肠梗阻 27）在选择接受替吉奥（S-1）治疗的患者，需要同时使用抗病毒药物索立夫定（antiviral）或化学相关类似物，例如溴夫定。在包括替吉奥的研究治疗前 4 周内不得使用这些药物。 28）妊娠或哺乳，或计划在研究治疗期间或 i）PD-1/PD-L1末次给药后 5 个月内，ii）替吉奥（S-1）或奥沙利铂末次给药后 6 个月怀孕，以时间较长者为准。有生育能力妇女在开始研究治疗前 14 天内的血清妊娠试验结果必须为阴性。 29）研究者认为应该排除的其他情况。

Exclusion criteria：

1) Stage IV (metastatic) or gastric cancer/GEJ cancer that cannot be surgically removed as determined by the researcher 2) Previously received non-surgical treatment for gastric cancer (such as radiotherapy, chemotherapy, and immunotherapy) 3) Screening for malignant tumors with a history other than GC within the first 5 years, but with a negligible risk of metastasis or death (such as a 5-year OS rate>90%), excluding malignant tumors such as fully treated cervical carcinoma in situ, non melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I cervical cancer 4) At the time of enrollment, there was cardiopulmonary dysfunction, defined by any of the following: a) Any classification of congestive heart failure b) Angina requiring treatment with anti angina drugs, severe arrhythmia that cannot be controlled by appropriate medication, severe conduction abnormalities, or clinically significant valve diseases c) High risk, uncontrolled arrhythmias (i.e. atrial tachycardia with resting heart rate>100 beats per minute, significant ventricular arrhythmias (ventricular tachycardia), or high degree atrioventricular block (type 2 atrioventricular block) or third degree atrioventricular block) d) Obvious symptoms related to left ventricular dysfunction, cardiac arrhythmia, or myocardial ischemia (level >= 2) e) Myocardial infarction within the first 12 months of randomization f) Uncontrolled hypertension (systolic blood pressure>180 mmHg and/or diastolic blood pressure>100 mmHg) g) Evidence of transmural myocardial infarction on ECG h) Oxygen therapy is required i) Difficulty breathing at rest 5) Active or history of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wagner's granuloma, Schering's syndrome, Guillain Barre syndrome, or multiple sclerosis (more detailed list of autoimmune diseases and immunodeficiency can be found in the protocol), except for the following: patients with a history of autoimmune hypothyroidism and undergoing thyroid replacement hormone therapy can participate in this study. a) Patients with controlled type 1 diabetes who received insulin regimen can participate in this study. b) Patients with eczema, psoriasis, chronic simple lichen, or vitiligo with only skin manifestations (e.g. excluding patients with psoriatic arthritis) are eligible to participate in this study if all of the following conditions are met. The skin rash must cover a surface area of<10% - The disease is well controlled at baseline, requiring only low-intensity topical corticosteroids There have been no acute exacerbations of underlying diseases requiring psoralen plus ultraviolet A radiation, methotrexate, retinoic acid, biologics, oral calcineurin inhibitors, or high-intensity or oral corticosteroids in the past 12 months. 6) Patients with idiopathic pulmonary fibrosis, organized pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, history of idiopathic pneumonia, or screening chest CT scans showing evidence of active pneumonia, and a history of radiation pneumonia (fibrosis) in the radiation field, may participate in this study. 7) Active pulmonary tuberculosis 8) Major surgery other than diagnostic purposes was performed within 4 weeks prior to the start of the study treatment, or it is expected that major surgery will be required during the study period 9) Severe infection occurred within 4 weeks prior to the start of the study treatment, including but not limited to hospitalization due to complications such as infection, bacteremia, or severe pneumonia 10) Treatment with therapeutic antibiotics within 2 weeks (IV antibiotics) or 5 days (oral antibiotics) prior to the start of the study treatment Patients who receive prophylactic antibiotic treatment (such as preventing urinary tract infections or worsening of chronic obstructive pulmonary disease) can participate in this study. 11) Previously received allogeneic stem cell transplantation or solid organ transplantation 12) Taboos to use study drugs, interpretations that may affect results, or any other diseases that put patients at high risk of treatment complications, metabolic dysfunction, physical examination results, or clinical laboratory test results 13) Vaccination with attenuated live vaccines within 4 weeks prior to the start of the study treatment, or expected to be administered during the treatment period with tirizumab or within 5 months after the last dose of tirizumab 14) Currently receiving HBV antiviral treatment 15) HIV test positive 16) Active hepatitis B patients (defined as those who tested positive for hepatitis B surface antigen HBsAg during screening) a) Previous HBV infection or recovered HBV infection (defined as HBsAg test negative or hepatitis B core antigen) b) Patients with positive anti-HBc antibodies and negative HBV-DNA test results during screening can be selected 17) Active hepatitis C patients a) HCV antibody positive patients only meet the criteria when the PCR result of HCV RNA is negative. 18) Evidence of serious, uncontrolled comorbidities that may affect protocol compliance or outcome interpretation, including severe liver diseases (such as cirrhosis, uncontrolled seizures, or superior vena cava syndrome) 19) Received any approved anti-tumor treatment within the first 5 half-lives prior to starting the treatment study 20) Received experimental treatment within 28 days prior to the start of the study treatment 21) Previously received CD137 agonist or immune checkpoint blockade therapy, including anti CTLA-4, anti PD-1, and anti PD-L1 therapeutic antibodies 22) Received systemic immune stimulants (including but not limited to interferon or interleukin-2) within 4 weeks prior to the start of the study treatment or within 5 half-lives of the drug (whichever is shorter) 23)Within 2 weeks prior to the start of the study treatment, systemic immunosuppressive drugs (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor) have been received- α (TNF)- α) Medication treatment a) Patients who have received acute, low-dose, systemic immunosuppressive drug treatment (such as a single dose of dexamethasone for nausea) may be enrolled in this study after discussion and approval with medical monitors. 24) Known allergy to any component of Tislelizumab preparations 25) Among patients who choose to receive treatment with tigio (S-1), it is known that dihydropyrimidine dehydrogenase (DPD) deficiency or a history of severe and unexpected reactions to fluoropyrimidine treatment is present 26) Significant impact on oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction 27) In patients who choose to receive treatment with tigio (S-1), antiviral drugs such as soriviral or chemically related analogues such as bromvudine need to be used simultaneously. These drugs should not be used within 4 weeks prior to the study treatment, including Tegio. 28) Pregnancy or lactation, or planned pregnancy within 5 months after the last dose of PD-1/PD-L1, or 6 months after the last dose of Tiggio (S-1) or Oxaliplatin, whichever is longer. Women with fertility must have a negative serum pregnancy test result within 14 days before starting the study treatment. 29) Other situations that researchers believe should be excluded.

研究实施时间：

Study execute time：

从 From 2023-08-01 00:00:00至 To 2026-08-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-01-03 00:00:00 至 To 2025-10-31 00:00:00

干预措施：

Interventions：

组别：	治疗组	样本量：	30
Group：	treatment group	Sample size：	30
干预措施：	术前替雷利珠单抗联合同步放化疗围手术期治疗	干预措施代码：
Intervention：	preoperative Tislelizumab plus chemoradiotherapy	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	单位级别：	三甲
Institution hospital：	LIAONING CANCER HOSPITAL & INSTITUTE	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	病理完全缓解率	指标类型：	主要指标
Outcome：	pathological complete response 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：	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：	主要病理学缓解率	指标类型：	次要指标
Outcome：	major pathological 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：	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：	R0切除率	指标类型：	次要指标
Outcome：	R0 resection 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：	不良事件（AE）的发生率	指标类型：	副作用指标
Outcome：	Incidence of adverse events (AE)	Type：	Adverse events
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 rate	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：	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：

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：	无
Blinding：	none
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	是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）：	研究完成，作者单位审核后，部分原始数据可通过邮箱与通讯作者联系获得
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Upon completion of the study and following review by the author's institution, interested parties may obtain portions of the original data by contacting the corresponding author via email.
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
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case Record Form, CRF
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2025-07-01 10:23:36