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：	ChiCTR2500115334
最近更新日期： Date of Last Refreshed on：	2025-12-24 17:39:07
注册时间： Date of Registration：	2025-12-24 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	评价RGL-232在携带KRAS突变的晚期恶性实体瘤患者中的安全性、耐受性及免疫原性的开放标签、多中心 I 期临床研究
Public title：	An open-label, multicenter Phase I clinical study to evaluate the safety, tolerability and immunogenicity of RGL-232 in patients with advanced malignant solid tumors carrying KRAS mutations
注册题目简写：
English Acronym：
研究课题的正式科学名称：	评价RGL-232在携带KRAS突变的晚期恶性实体瘤患者中的安全性、耐受性及免疫原性的开放标签、多中心 I 期临床研究
Scientific title：	An open-label, multicenter Phase I clinical study to evaluate the safety, tolerability and immunogenicity of RGL-232 in patients with advanced malignant solid tumors carrying KRAS mutations
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：	吴思远	研究负责人：	宋正波
Applicant：	Siyuan Wu	Study leader：	Zhengbo Song
申请注册联系人电话： Applicant telephone：	+86 181 2049 3116	研究负责人电话： Study leader's telephone：	+86 138 5715 3345
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：	siyuan.wu@regenelead.com	研究负责人电子邮件： Study leader's E-mail：	songzb@zjcc.org.cn
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：	中国上海市浦东新区恒瑞创新研发中心	研究负责人通讯地址：	中国浙江省杭州市拱墅区半山东路1号
Applicant address：	Hengrui Innovation R&D Center, Pudong New Area, Shanghai, China	Study leader's address：	No. 1, Banshan East Road, Gongshu District, Hangzhou City, Zhejiang Province, 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：	上海瑞宏迪医药有限公司
Applicant's institution：	Shanghai Ruihongdi Pharmaceutical Co., LTD
研究负责人所在单位：	浙江省肿瘤医院
Affiliation of the Leader：	Zhejiang Cancer Hospital

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：	IRB-2025-2279(IST)	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：	浙江省肿瘤医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Zhejiang Cancer Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2025-12-08 00:00:00
伦理委员会联系人：	朱骥
Contact Name of the ethic committee：	Ji Zhu
伦理委员会联系地址：	中国浙江省杭州市拱墅区半山东路1号
Contact Address of the ethic committee：	No. 1, Banshan East Road, Gongshu District, Hangzhou City, Zhejiang Province, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 571 8812 2146	伦理委员会联系人邮箱： Contact email of the ethic committee：	irb@zjcc.org.cn

研究实施负责（组长）单位：

浙江省肿瘤医院

Primary sponsor：

Zhejiang Cancer Hospital

研究实施负责（组长）单位地址：

中国浙江省杭州市拱墅区半山东路1号

Primary sponsor's address：

No. 1, Banshan East Road, Gongshu District, Hangzhou City, Zhejiang Province, 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)：	上海市
Country：	China	Province：	Shanghai	City：	Shanghai
单位(医院)：	上海瑞宏迪医药有限公司	具体地址：	中国上海自由贸易试验区新金桥路27号13号楼2楼
Institution hospital：	Shanghai Ruihongdi Pharmaceutical Co., LTD	Address：	2nd Floor, Building 13, No. 27, Xinjinqiao Road, Shanghai Pilot Free Trade Zone, China

国家：	中国	省(直辖市)：	广东省	市(区县)：	广州市
Country：	China	Province：	Guangdong	City：	Guangzhou
单位(医院)：	广州瑞领医药有限公司	具体地址：	广州市黄埔区（中新广州知识城）亿创街1号406房之1159
Institution hospital：	Guangzhou Ruiling Pharmaceutical Co., LTD	Address：	Room 1159, 406, No. 1 Yichuang Street, Huangpu District, Guangzhou City (China-Singapore Guangzhou Knowledge City)

经费或物资来源：

广州瑞领医药有限公司

Source(s) of funding：

Guangzhou Ruiling Pharmaceutical Co., LTD

研究疾病：

晚期恶性实体瘤

Target disease：

Advanced malignant solid tumor

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：

I期临床试验

Study phase：

1

研究设计：

单臂

Study design：

Single arm

研究目的：

评价RGL-232在携带KRAS突变的晚期恶性实体瘤患者中的安全性和耐受性，确定RGL-232单药的最大耐受剂量（MTD）和/或推荐扩展剂量（RDE）

Objectives of Study：

To evaluate the safety and tolerability of RGL-232 in patients with advanced malignant solid tumors carrying KRAS mutations, and to determine the maximum tolerated dose (MTD) and/or recommended extended dose (RDE) of RGL-232 monotherapy

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. The subjects should understand and abide by the relevant research procedures and voluntarily sign the informed consent form;
2. Age >=18 years old, gender not limited;
3. Subjects with locally advanced or metastatic solid tumors confirmed by pathology and carrying KRAS (G12C, G12D, G12V or G13D) mutations; KRAS mutation information can be sourced from:
-Previously conducted KRAS gene testing can provide KRAS mutation diagnosis reports from existing medical institutions/diagnostic institutions.
-For those who have not undergone KRAS gene testing in the past, tumor tissue specimens and blood samples need to be sent to the central laboratory for testing first.
4. For patients with locally advanced or metastatic solid tumors, if the disease progresses as evaluated by imaging and there is no standard treatment plan or standard treatment has failed or standard treatment cannot be obtained;
5. At least one measurable tumor lesion must be present during screening [in accordance with RECIST V1.1 criteria]. For lesions that have previously received radiotherapy or other local treatments, disease progression must be confirmed by imaging before they can be regarded as measurable lesions.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status Score: 0 or 1 point;
7. Expected survival period >=3 months;
8. The functions of vital organs meet the following criteria (no blood components or cell growth factors have been used within 14 days prior to the start of the study and treatment) :
a) Blood routine: Neutrophil count (ANC) >=1.5×10^9/L, lymphocyte count (LYM) >=0.5×10^9/L, platelet count (PLT) >=100×10^9/L, hemoglobin (Hb) >=90g/L;
b) Blood biochemistry: Total bilirubin (TBIL) <=1.5× upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3×ULN (ALT and AST can be <=5×ULN in subjects with liver metastases or primary liver tumors), serum albumin (ALB) >=30g/L Serum creatinine (Scr) <=1.5×ULN. When creatinine > 1.5×ULN, the estimated creatinine clearance rate (Clcr) using the Cockcroft-Gault (C-G) formula is greater than 50mL/min. Or the glomerular filtration rate (eGFR) estimated using the Modified Diet for Kidney Disease (MDRD) equation is greater than 50 mL/min;
c) Coagulation routine: International Normalized ratio (INR) <=1.5, activated partial thromboplastin time (APTT) <=1.5×ULN;
d) Cardiac function: Left ventricular ejection fraction (LVEF) >=50%;
9. Female subjects with fertility must undergo a serum pregnancy test within 7 days before the first dose of the vaccine, and the result must be negative, and they must not be in the lactation period.
10. Female subjects of fertility and male subjects whose partners are women of childbearing age must agree to comply with contraceptive requirements from the date of signing the informed consent form until 6 months after the end of the last treatment.

排除标准：

1. 接受过免疫细胞或肿瘤疫苗治疗，包括但不限于肿瘤浸润淋巴细胞（TILs）、嵌合抗原受体 T/NK 细胞（CAR-T/NK）、T 细胞受体嵌合 T 细胞（TCR-T）以及治疗性肿瘤疫苗等； 2. 计划在筛选期内或研究期间及研究药物治疗结束后 90 天内接种减毒活疫苗（允许接种灭活疫苗）； 3. 既往发生永久停药的免疫相关不良反应者； 4. 自身免疫性疾病活动期或者需要长期接受免疫抑制剂治疗的自身免疫性疾病（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 TNF-α 药物），但以下情况除外： - 接受盐皮质激素（如氟氢可的松）、吸入性或低剂量皮质类固醇治疗（强的松≤15mg/天或等价剂量的同类药物）慢性阻塞性肺疾病（COPD）或哮喘者； - 低剂量皮质类固醇治疗体位性低血压或肾上腺功能不全者； 5. 已知有癫痫病史或其他有症状的神经系统疾病； 6. 筛选时或者既往有脑膜转移，有临床症状的活动性脑转移。以下情况除外：a.无症状脑转移同时脑转移灶＜1cm 周围无水肿带；b.脑转移接受过治疗且症状稳定、影像学检查显示在首次疫苗给药前稳定至少 4 周无需糖皮质激素或者抗惊厥药物治疗； 7. 已知有精神类药物滥用、酗酒或吸毒史； 8. 筛选期前 1 年内及筛选期间有活动性结核感染证据，无论是否治疗； 9. 首次疫苗给药前 6 个月内具有需要类固醇治疗的（非感染性）间质性肺病（ILD）/非感染性肺炎病史，或者目前患有需要治疗的间质性肺病或肺纤维化、尘肺、放射性肺炎、肺功能严重受损等可能会干扰可疑的药物相关肺毒性的检测和处理者的患者； 10. 在过去 5 年内患有其他恶性肿瘤，以下情况除外：距研究药物首次给药前，已治愈 2 年的皮肤基底细胞癌、浅表性膀胱癌、皮肤鳞状细胞癌、甲状腺乳头状癌、前列腺原位癌或宫颈原位癌，且研究期间无需或预期不需要其他治疗； 11. 已知有异体器官移植史或异体造血干细胞移植史，或筛选前3 个月内进行自体移植者； 12. 已知对研究药物或其任何辅料过敏，或对其他疫苗发生过重度过敏反应史； 13. 患有先天或后天免疫功能缺陷，如细胞性免疫缺陷（如DiGeorge 综合征、T 阴性严重联合免疫缺陷[SSCID]）或联合 T 细胞和 B 细胞免疫缺陷（例如 T-和 B-阴性联合免疫缺陷、Wiskott-Aldrich 综合征、共济失调毛细血管扩张症、常见的可变免疫缺陷）； 14. 首次疫苗给药前 6 个月内曾出现过有重要临床意义的心脑血管疾病，包括：(1)急性心肌梗死；(2)不稳定型心绞痛；(3)脑血管意外；(4)有临床意义的室性心律失常病史（如持续的室性心动过速，室颤，尖端扭转型室性心动过速）；(5)纽约心脏协会（NYHA）III 或 IV 级充血性心力衰竭；(6)QTcF≥470ms（女性）或≥ 450ms（男性）或先天性长 QT 综合征病史或家族史；(7)基线左心室射血分数（LVEF）< 50%或通过超声心动图（ECHO）发现严重室壁运动障碍；(8)药物治疗控制不佳的的高血压受试者，其收缩压>160mmHg 或舒张压>100mmHg；既往曾出现高血压危象或高血压性脑病；(9)需要抗心律失常药物治疗的心律失常（在研究药物首次给药之前> 1 个月患有心率可控制的房颤的受试者除外）； 15. 首次疫苗给药前 4 周内存在重度感染，或给药前 2 周内存在需使用静脉或者口服抗感染药物治疗的活动性感染； 16. 有临床症状的中度、重度胸腹水（即开始研究治疗前 4 周内胸腹水经过引流治疗后仍无法控制的患者，仅影像学显示少量胸腹水且不伴有临床症状者可入组）；无法控制或中等量及以上的心包积液； 17. 活动性乙型肝炎（定义为筛选期活动性乙肝病毒表面抗原[HBsAg] 检测结果呈阳性同时检测到 HBV DNA ≥500IU/mL），或丙型肝炎（定义为筛选期丙肝抗体[HCV-Ab]检测结果呈阳性，且 HCV-RNA 阳性），或血清人类免疫缺陷病毒（HIV）抗体阳性或有活动性 HIV 感染史，或活动性梅毒（梅毒抗体阳性且滴度＞1:8）； 18. 首次疫苗给药前 3 个月内发生动/静脉血栓事件，如脑血管意外、深静脉血栓或肺栓塞等；以下情况除外：允许为静脉通路装置的通畅进行预防性抗凝；允许预防性使用低分子量肝素（例如依诺肝素 40 mg/天）； 19. 首次疫苗给药前 4 周内接受过重大外科手术者； 20. 既往抗肿瘤治疗引起的不良事件未恢复至≤CTCAE 1 级（方案规定的器官功能、2 级外周神经病变，脱发和/或激素替代治疗可控的甲状腺功能减退或肾上腺功能减退症或胰岛素控制良好的 1 型糖尿病除外）； 21. 在首次疫苗给药前 4 周内接受过化疗、根治性放疗、生物治疗、内分泌治疗、靶向治疗、免疫治疗等抗肿瘤治疗，接受如下治疗者要求： - 口服氟尿嘧啶类、小分子靶向药物为首次疫苗给药前 2周内或已知的药物的 5 个半衰期内（以时间短的为准）； - 在首次疫苗给药前 2 周内接受过姑息性放疗； - 在首次疫苗给药前 1 周内使用过抗肿瘤适应症的中药或中成药； 22. 研究者判断受试者可能影响临床研究进行及研究结果的其他情况，如受试者面临安全性风险的任何其他疾病；受试者依从性差或主动要求退出筛选等。

Exclusion criteria：

1. Received immune cell or tumor vaccine treatment, including but not limited to tumor-infiltrating lymphocytes (TILs), chimeric antigen receptor T/NK cells (CAR-T/NK), T-cell receptor chimeric T cells (TCR-T), and therapeutic tumor vaccines, etc. 2. It is planned to receive live attenuated vaccines during the screening period or the study period and within 90 days after the end of the study drug treatment (inactivated vaccines are allowed). 3. Those who have experienced immune-related adverse reactions after permanent drug withdrawal in the past; 4. Autoimmune diseases in the active stage or requiring long-term immunosuppressant treatment (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide and anti-TNF -α drugs), except for the following situations: -Patients with chronic obstructive pulmonary disease (COPD) or asthma who are receiving mineralocorticoids (such as fludrocortisone), inhaled or low-dose corticosteroids (prednisone ≤15mg/ day or equivalent doses of similar drugs); -Patients with orthostatic hypotension or adrenal insufficiency treated with low-dose corticosteroids; 5. There is a known history of epilepsy or other symptomatic neurological disorders; 6. Active brain metastases with clinical symptoms at the time of screening or in the past. The following situations are excluded: a. Asymptomatic brain metastasis with the brain metastasis lesion < 1cm and no edema band around it; b. Brain metastases have received treatment with stable symptoms, and imaging examinations show that they have been stable for at least 4 weeks before the first dose of the vaccine and do not require glucocorticoid or anticonvulsant drug treatment; 7. There is a known history of abuse of psychotropic substances, alcohol abuse or drug use; 8. There is evidence of active tuberculosis infection within one year before the screening period and during the screening period, regardless of whether treatment has been received; 9. Patients with a history of (non-infectious) interstitial lung disease (ILD)/non-infectious pneumonia requiring steroid treatment within 6 months prior to the first dose of the vaccine, or those currently suffering from interstitial lung disease requiring treatment or pulmonary fibrosis, pneumoconiosis, radiation pneumonitis, severely impaired lung function, etc., which may interfere with the detection and management of suspected drug-related lung toxicity; 10. Having suffered from other malignant tumors within the past five years, except for the following situations: cutaneous basal cell carcinoma, superficial bladder cancer, cutaneous squamous cell carcinoma, papillary thyroid carcinoma, prostate carcinoma in situ or cervical carcinoma in situ that have been cured for two years before the first administration of the study drug, and no or expected no other treatment was needed during the study period; 11. Those who have a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or have undergone autologous transplantation within 3 months prior to screening; 12. Known to be allergic to the research drug or any of its excipients, or have a history of severe allergic reactions to other vaccines; 13. Suffering from congenital or acquired immune deficiency Such as cellular immune deficiencies (such as DiGeorge syndrome, T-negative severe combined immunodeficiency [SSCID]) or combined T-cell and B-cell immune deficiencies (such as T- and B-negative combined immunodeficiency, Wiskott-Aldrich Syndrome, ataxia telangiectasia, common variable immune deficiency; 14. Significant cardiovascular and cerebrovascular diseases of clinical importance have occurred within 6 months prior to the first dose of the vaccine, including: (1) Acute myocardial infarction; (2) Unstable angina pectoris; (3) Cerebrovascular accident; (4) A history of clinically significant ventricular arrhythmias (such as persistent ventricular tachycardia, ventricular fibrillation, torsional pointed-point ventricular tachycardia); (5) New York Heart Association (NYHA) grade III or IV congestive heart failure; (6) QTcF>=470ms (for females) or >= 450ms (for males), or a history of congenital long QT syndrome or family history; (7) Baseline left ventricular ejection fraction (LVEF) < 50% or severe ventricular wall movement disorder is detected by echocardiography (ECHO); (8) For hypertensive subjects with poor control through drug treatment, whose systolic blood pressure is greater than 160mmHg or diastolic blood pressure is greater than 100mmHg; There has been a history of hypertensive crisis or hypertensive encephalopathy; (9) Arrhythmias requiring antiarrhythmic drug treatment (excluding subjects with controllable atrial fibrillation more than one month before the first administration of the study drug); 15. There was a severe infection within 4 weeks before the first vaccine administration, or there was an active infection within 2 weeks before administration that required intravenous or oral anti-infective drug treatment; 16. Patients with moderate to severe pleural and peritoneal effusion with clinical symptoms (i.e., those whose pleural and peritoneal effusion cannot be controlled after drainage treatment within 4 weeks before the start of the study treatment, and who only show a small amount of pleural and peritoneal effusion on imaging without clinical symptoms can be enrolled); Uncontrolled or moderate to excessive pericardial effusion; 17. Active hepatitis B (defined as positive results of active hepatitis B surface antigen [HBsAg] test during the screening period and HBV DNA >=500IU/mL detected at the same time), or hepatitis C (defined as positive results of hepatitis C antibody [HCV-Ab] test during the screening period) And HCV-RNA positive, or positive serum human immunodeficiency virus (HIV) antibody or having a history of active HIV infection, or being active Syphilis (positive syphilis antibody with titer > 1:8); 18. If an arterial or venous thrombotic event occurs within 3 months before the first dose of the vaccine, such as a cerebrovascular accident, deep vein thrombosis or pulmonary embolism, etc. The following situations are excluded: preventive anticoagulation is permitted for the patency of venous access devices; The prophylactic use of low-molecular-weight heparin (such as enoxaparin 40 mg/ day) is permitted; 19. Those who have undergone major surgical operations within 4 weeks prior to the first dose of the vaccine; 20. Adverse events caused by previous anti-tumor treatment have not been restored to <=CTCAE grade 1 (except for organ function specified in the protocol, grade 2 peripheral neuropathy, alopecia and/or hypothyroidism or adrenal insufficiency controlled by hormone replacement therapy or type 1 diabetes well controlled by insulin); 21. For those who have received anti-tumor treatments such as chemotherapy, radical radiotherapy, biological therapy, endocrine therapy, targeted therapy, and immunotherapy within 4 weeks prior to the first dose of the vaccine, the following treatments are required: -Oral fluorouracil and small molecule targeted drugs should be administered within 2 weeks before the first vaccine administration or within 5 half-lives of known drugs (whichever is shorter). -Received palliative radiotherapy within 2 weeks before the first vaccine administration; - Has used traditional Chinese medicine or Chinese patent medicine with anti-tumor indications within one week before the first dose of the vaccine; 22. Other circumstances in which the researcher determines that the subject may affect the progress of the clinical study and the research results, such as any other diseases that pose safety risks to the subject; Poor compliance of the subjects or their active request to withdraw from the screening, etc.

研究实施时间：

Study execute time：

从 From 2025-12-25 00:00:00至 To 2027-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-12-26 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：	单药剂量递增	样本量：	12
Group：	Dose escalation of monotherapy	Sample size：	12
干预措施：	预设低中高三个剂量水平，每3周为1个治疗周期（Q3W），每周期第1天给药，给药9周期之后，调整至每6周（Q6W）为1个周期给药（或由研究者根据受试者疾病状态、免疫应答情况调整给药间隔）。	干预措施代码：
Intervention：	Preset three dose levels: low, medium and high. Each treatment cycle was set at 3 weeks (Q3W), with administration on the first day of each cycle. After 9 cycles, the administration was adjusted to every 6 weeks (Q6W) as one cycle (or the researcher adjusted the administration interval based on the disease status and immune response of the subjects).	Intervention code：

组别：	单药剂量扩展	样本量：	20
Group：	Single-drug dose expansion	Sample size：	20
干预措施：	选择1~2个不高于当前已证明安全、可耐受的剂量水平进行剂量扩展研究，每3周为1个治疗周期（Q3W），每周期第1天给药，给药9周期之后，调整至每6周（Q6W）为1个周期给药（或由研究者根据受试者疾病状态、免疫应答情况调整给药间隔）。	干预措施代码：
Intervention：	Select 1 to 2 dose levels that are no higher than the currently proven safe and tolerable for dose expansion studies. Each treatment cycle lasts for 3 weeks (Q3W), with administration on the first day of each cycle. After 9 cycles, adjust the administration to every 6 weeks (Q6W) as one cycle (or adjust the administration interval based on the disease status and immune response of the subjects by the researcher).	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	浙江	市(区县)：
Country：	China	Province：	Zhejiang	City：
单位(医院)：	浙江省肿瘤医院	单位级别：	三甲
Institution hospital：	Zhejiang Cancer Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	安全性和耐受性	指标类型：	主要指标
Outcome：	Safety and Tolerability	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	药代动力学	指标类型：	次要指标
Outcome：	Pharmacokinetic	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	免疫原性	指标类型：	次要指标
Outcome：	Immunogenicity	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	初步疗效	指标类型：	次要指标
Outcome：	Preliminary therapeutic effect	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	生物标志物	指标类型：	附加指标
Outcome：	Biomarker	Type：	Additional 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：

标本中文名：	肿瘤组织	组织：
Sample Name：	Tumor 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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	999	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：
Blinding：

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)：	NA
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：	电子采集和管理系统
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	EDC
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：	2025-12-24 17:38:27