ChiCTR2600123456 版本V1.0 版本创建时间2026/04/27 11:15:37 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：

ChiCTR2600123456 

最近更新日期：

Date of Last Refreshed on：

2026-04-27 11:15:26 

注册时间：

Date of Registration：

2026-04-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

吉卡昔替尼联合替雷利珠单抗用于治疗免疫难治性肝细胞肝癌的单臂临床试验 （LIGHT-006）

Public title：

A Single-Arm Clinical Trial (LIGHT-006) of Gecacitinib Combined with Tislelizumab for the Treatment of Immunotherapy-Refractory Hepatocellular Carcinoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

吉卡昔替尼联合替雷利珠单抗用于治疗免疫难治性肝细胞肝癌的单臂临床试验 （LIGHT-006）

Scientific title：

A Single-Arm Clinical Trial (LIGHT-006) of Gecacitinib Combined with Tislelizumab for the Treatment of Immunotherapy-Refractory Hepatocellular 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：

刘智鹏 

研究负责人：

陈志宇 

Applicant：

Zhipeng Liu 

Study leader：

Zhiyu Chen 

申请注册联系人电话：

Applicant telephone：

+86 18999891115

研究负责人电话：

Study leader's telephone：

+86 23 65460505

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：

liuzhipeng1115@163.com

研究负责人电子邮件：

Study leader's E-mail：

chenzhiyu_umn@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：

重庆市沙坪坝区高滩岩正街29号

研究负责人通讯地址：

重庆市沙坪坝区高滩岩正街29号

Applicant address：

No. 29, Zhengjie Street, Gaotanyan, Shapingba District, Chongqing City

Study leader's address：

No. 29, Zhengjie Street, Gaotanyan, Shapingba District, Chongqing City

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：

中国人民解放军陆军军医大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of the Army Medical University of the People's Liberation Army of China

研究负责人所在单位：

中国人民解放军陆军军医大学第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of the Army Medical University of the People's Liberation Army of China

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：

（A）KY2026073

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：

中国人民解放军陆军军医大学第一附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Army Medical University PLA

伦理委员会批准日期：

Date of approved by ethic committee：

2026-03-19 00:00:00

伦理委员会联系人：

贺莉

Contact Name of the ethic committee：

Li He

伦理委员会联系地址：

重庆市沙坪坝区高滩岩正街29号

Contact Address of the ethic committee：

No. 29, Zhengjie Street, Gaotanyan, Shapingba District, Chongqing City

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 23 68754035

伦理委员会联系人邮箱：

Contact email of the ethic committee：

cqhl13@qq.com

研究实施负责（组长）单位：

中国人民解放军陆军军医大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Army Medical University

研究实施负责（组长）单位地址：

重庆市沙坪坝区高滩岩正街29号

Primary sponsor's address：

No. 29, Zhengjie Street, Gaotanyan, Shapingba District, Chongqing 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)：

重庆市

市(区县)：

Country：

China

Province：

Chongqing

City：

单位(医院)：

中国人民解放军陆军军医大学第一附属医院

具体地址：

重庆市沙坪坝区高滩岩正街29号

Institution
hospital：

The First Affiliated Hospital of Army Medical University

Address：

No. 29, Zhengjie Street, Gaotanyan, Shapingba District, Chongqing City

经费或物资来源：

无

Source(s) of funding：

None

Target disease：

Immune-refractory hepatocellular carcinoma

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

单臂 

Study design：

Single arm 

研究目的：

评价吉卡昔替尼联合替雷利珠单抗治疗免疫难治性肝细胞癌的有效性和安全性  

Objectives of Study：

To evaluate the efficacy and safety of gecacitinib combined with tislelizumab in the treatment of immune-refractory hepatocellular 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<=80 岁，男性或女性。 2.签署《知情同意书》。 3.经临床、影像和/或病理学诊断为肝细胞癌（根据卫健委《原发性肝癌诊疗指南（2024 年版）》。 4.经标准一线或后线免疫治疗（无论是否联合靶向药物）后进展的肝细胞癌患者。一线或后线免疫治疗主要参考美国国立综合癌症网络（NCCN）指南（Version 1.2025）的推荐，包括但不限于曲美木单抗联合度伐利尤单抗、阿特珠单抗联合贝伐珠单抗、替雷利珠单抗等方案。 5.经研究者评估，适合接受本研究方案规定的治疗（替雷利珠单抗联合吉卡昔替尼）且符合用药标准。 6.ECOG 体能状态评分为 0-1 分。 7.Child-Pugh 肝功能分级：<=7。 8.根据 RECIST v1.1 标准，至少有一个可测量病灶。 9.预期生存时间超过 3 个月。 10.主要器官功能符合下列要求（除特殊定义外，在入组前 7 天内）：1.血常规检查须符合以下标准：（1）中性粒细胞绝对计数（ANC）>=1.5×10^9 /L，不能通过使用粒细胞集落刺 激因子达到要求；(2)血小板（PLT）>=100×10^9/L，不能通过输血来达到此要求；（3）血红蛋白>=90g/L; 2.血生化检查须符合以下要求：（1）血清白蛋白（ALB）>=30g/L；（2）总胆红素（TBil）<=1.5×ULN，或总胆红素＞1.5×UNL 且间接胆红<=1×UNL；（3）谷草转氨酶（AST）<=3×ULN；（4）谷丙转氨酶（ALT）<=3×ULN；（5）血清肌酐（Cr）<=1.5×ULN；或 Cr 清除率＞50 ml/min； （Cockcroft -Gault 公式如下）： 男性：Cr 清除率=（（140-年龄）×体重）/（72×血 Cr） 女性：Cr 清除率=（（140-年龄）×体重）/（72×血 Cr）×0.85 体重单位：kg；血 Cr 单位：mg/ml ；4.国际标准化比率（INR）<=1.5 或凝血酶原时间（PT）超过正常对照的范围 <=4 秒； 11.若受试者合并 HBV 或 HCV 感染，则须满足下述条件：HBV 感染受试者（HBsAg 或 HBV-DNA 阳性）：首次治疗前 28 天内 HBV-DNA＜2000IU/ml，研究期间须继续接受规范抗病毒治疗；HCV 感染受试者（HCVAb 或 HCV-RNA 阳性）：根据研究者判断处于稳定状态，如正在接受抗病毒治疗，研究期间应继续接受治疗。 12.有生育能力的女性受试者必须在首次给药前 7 天内进行血清妊娠试验且检查结果为阴性，且不在哺乳期，必须同意在试验期间和末次给予药物后 6 个月内采 用有效避孕措施；对于伴侣为有生育能力女性的男性受试者，应为手术绝育或同 意在试验期间和末次给予药物后 3 个月内采用有效避孕措施，研究期间不允许捐 精。 13.受试者依从性良好，配合随访。

Inclusion criteria

1. Age >= 18 years and <= 80 years, male or female. 2. Sign the "Informed Consent Form". 3. Diagnosed with hepatocellular carcinoma through clinical, imaging and/or pathological examination (in accordance with the "Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition)" issued by the National Health Commission). 4. Patients with hepatocellular carcinoma who have progressed after standard first-line or second-line immunotherapy (regardless of whether combined with targeted drugs). The first-line or second-line immunotherapy mainly refers to the recommendations of the National Comprehensive Cancer Network (NCCN) guidelines (Version 1.2025), including but not limited to trastuzumab emtansine combined with durvalumab, atezolizumab combined with bevacizumab, tislelizumab, etc. 5. Evaluated by the investigator to be suitable for the treatment specified in this study protocol (trastuzumab combined with gicipritinib) and meeting the medication standards. 6. ECOG performance status score of 0-1. 7. Child-Pugh liver function classification: <= 7. 8. According to the RECIST v1.1 standard, there must be at least one measurable lesion. 9. Expected survival time exceeds 3 months. 10. The main organ functions meet the following requirements (except for special definitions, within 7 days before enrollment): 1. Blood routine examination must meet the following standards: (1) Absolute neutrophil count (ANC) >= 1.5 × 10^9 /L, cannot be achieved by using granulocyte colony-stimulating factor; (2) Platelets (PLT) >= 100 × 10^9/L, cannot be achieved by blood transfusion; (3) Hemoglobin >= 90 g/L; 2. Blood biochemical examination must meet the following requirements: (1) Serum albumin (ALB) >= 30 g/L; (2) Total bilirubin (TBil) <= 1.5 × ULN, or total bilirubin > 1.5 × UNL and indirect bilirubin <= 1 × UNL; (3) Aspartate aminotransferase (AST) <= 3 × ULN; (4) Alanine aminotransferase (ALT) <= 3 × ULN; (5) Serum creatinine (Cr) <= 1.5 × ULN; or Cr clearance rate > 50 ml/min (Cockcroft-Gault formula as follows): Male: Cr clearance rate = ((140 - age) × weight) / (72 × blood Cr) Female: Cr clearance rate = ((140 - age) × weight) / (72 × blood Cr) × 0.85 Weight unit: kg; Blood Cr unit: mg/ml; 4. International normalized ratio (INR) <= 1.5 or prothrombin time (PT) exceeds the normal control range <= 4 seconds; 11. If the subject has HBV or HCV infection, the following conditions must be met: HBV-infected subjects (HBsAg or HBV-DNA positive): HBV-DNA < 2000 IU/ml within 28 days before the first treatment, and must continue to receive standardized antiviral treatment during the study; HCV-infected subjects (HCVAb or HCV-RNA positive): According to the investigator's judgment, in a stable state, if receiving antiviral treatment, must continue to receive treatment during the study. 12. Female subjects with reproductive capacity must undergo a serum pregnancy test 7 days before the first administration and the result must be negative, and not be in the lactation period. Must agree to use effective contraceptive measures during the study and within 6 months after the last administration of the drug; For male subjects whose partner is a fertile female, surgical sterilization or must agree to use effective contraceptive measures during the study and within 3 months after the last administration of the drug. During the study, sperm donation is not allowed. 13. The subject has good compliance and cooperates with follow-up.

排除标准：

1.已知病理类型为胆管癌或胆管癌-肝细胞癌混合型；5 年内或同时患有除肝细胞癌之外的其它恶性肿瘤。已治愈的局限性肿瘤，如皮肤基底细胞癌、皮肤鳞癌、表浅膀胱癌、前列腺原位癌、宫颈原位癌、乳腺原位癌等可以入组。 2.有肝性脑病病史者。 3.存在梗阻性黄疸（经胆道引流或支架放置等积极治疗，肝脏功能恢复后可以入组）。 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患者。 5.有临床症状的中度、重度腹水，即需要治疗性穿刺、引流者或 Child-Pugh 评分中的腹水评分>2（仅影像学显示少量腹水但不伴有临床症状者除外）；不受控制的胸腔积液、心包积液。 6.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：有出血危险的食管胃底静脉曲张、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者需复查，复查后若仍为阳性，需要进行胃镜检查，若胃镜提示有出血风险的食管胃底静脉曲张则不能入组）。 7.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）。 8.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。 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（见附件）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>450ms（男性）；QT >470ms（女性）（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.在开始研究治疗之前 6 个月内曾患肠梗阻和/或曾有胃肠道梗阻临床体征或症状，包括与原有疾病有关或需要常规肠外水化、肠外营养或管饲的不完全梗阻。 11.既往和目前有肺纤维化史、机化性肺炎（例如，闭塞性细支气管炎）、间质 性肺炎、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等可能会干扰可疑的药物相关肺毒性的检测和处理的受试者，不允许辐射区曾有放射性肺炎。 12.存在任何活动性自身免疫病或有自身免疫病病史且预期复发（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]）；受试者患有无需全身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，成年后无需任何干预的患者可纳入；需要支气管扩张剂进行医学干预的哮喘患者则不能纳入。 13.患者正在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），并在签署知情同意书之前 2 周内仍在继续使用的。 14.在开始研究治疗之前 28 天内接受过减毒活疫苗治疗，或预期于治疗期间至末次给药后 60 天内需要接种此类疫苗。 15.活动性结核；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）的患者有资格参与研究）；患者有活动性感染、随机前 7 天内有不明原因发热≥38.5℃、或基线期白细胞计数>15×10^9/L。 16.患有高血压，且经降压药物治疗无法获得良好控制（收缩压>=140 mmHg 或者舒张压>=90 mmHg）（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。 17.患者先天或后天免疫功能缺陷（如 HIV 感染者）。 18.已知对研究药物或辅料或同类药物过敏者。 19.研究者认为不适合参加本研究的其他因素。

Exclusion criteria：

1.The known pathological type was cholangiocarcinoma or cholangio-hepatocellular carcinoma mixed type. 5 years or concurrent malignant tumors other than hepatocellular carcinoma. Localized tumors that had been cured, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast, could be enrolled. 2.Patients with a history of hepatic encephalopathy. 3.Patients with obstructive jaundice (after active treatment such as biliary drainage or stent placement and liver function recovery) could be enrolled. 4.Patients who were preparing for or had previously received organ or allogeneic bone marrow transplantation. 5.Moderate or severe ascites with clinical symptoms, which required therapeutic puncture or drainage, or ascites score >2 in the Child-Pugh score (except those with only a small amount of ascites on imaging but no clinical symptoms); Uncontrolled pleural effusion, pericardial effusion. 6.A history of gastrointestinal bleeding within 6 months before the initiation of study treatment or a definite tendency to gastrointestinal bleeding, such as: Patients with esophagogastric varices at risk for bleeding, local active peptic ulcer lesions, or persistent positive fecal occult blood were excluded (patients with positive fecal occult blood at baseline required repeat testing, and patients with positive fecal occult blood after repeat testing required gastroscopy. Patients with esophagogastric varices at risk for bleeding on gastroscopy were excluded). 7.Known inherited or acquired bleeding (such as coagulopathy) or thrombophilia, as in patients with hemophilia; Current or recent (within 10 days before the initiation of study treatment) use of full-dose oral or injectable anticoagulant or thrombolytic agents for therapeutic purposes (prophylactic use of low-dose aspirin and low-molecular-weight heparin was allowed). 8.Thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc., occurred within 6 months before the initiation of study treatment. 9.Clinical symptoms or diseases of the heart that are not well controlled, such as: (1) grade II or higher cardiac dysfunction according to the New York Heart Association (NYHA) criteria (see Appendix) or cardiac color Doppler ultrasound examination: Left ventricular ejection fraction (LVEF) <50% (2) unstable angina (3) myocardial infarction within 1 year before study treatment (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention (5) QTc>450ms (men); QT >470ms (in women). (QTc intervals were calculated with the use of Fridericia's formula; if QTc was abnormal, three consecutive measurements were performed at 2-minute intervals and averaged.); 10.A history of intestinal obstruction and/or clinical signs or symptoms of gastrointestinal obstruction within 6 months before starting study treatment, including incomplete obstruction related to preexisting disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding. 11.Previous and current history of pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), and interstitial disease Patients with pneumonitis, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or evidence of active pneumonia on chest computed tomography (CT) during screening or severe impairment of lung function that may interfere with the detection and management of suspected drug-related pulmonary toxicity were not allowed to have radiation pneumonitis in the radiation area. 12.The presence of any active autoimmune disease or a history of autoimmune disease with expected recurrence (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [eligible if controlled only with hormone replacement therapy]); Subjects with skin diseases requiring no systemic treatment such as vitiligo, psoriasis, alopecia, controlled type I diabetes treated with insulin, or asthma that had resolved completely in childhood without any intervention in adulthood were included. Patients with asthma who required medical intervention with bronchodilators were excluded. 13.Patients were receiving immunosuppressive or systemic hormone therapy for immunosuppression (at a dose of >10mg per day of prednisone or other equivalent efficacy hormones) and had continued to do so within 2 weeks before signing informed consent. 14.Patients were receiving immunosuppressive or systemic hormone therapy for immunosuppression (at a dose of >10mg per day of prednisone or other equivalent efficacy hormones) and had continued to do so within 2 weeks before signing informed consent. 15.Active tuberculosis; Severe infection within 4 weeks before starting study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; Therapeutic oral or intravenous antibiotics had been given within 2 weeks before starting study treatment (patients receiving prophylactic antibiotics (e.g., to prevent urinary tract infection or exacerbations of chronic obstructive pulmonary disease) were eligible). Patients had active infection, fever of unknown origin of 38.5 ° C or higher within 7 days before randomization, or a baseline white-cell count of more than 15×109 per liter. 16.Hypertensive patients who had hypertension that was not well controlled with antihypertensive medication (systolic blood pressure, >=140 mmHg or diastolic blood pressure, >=90 mmHg) (on the basis of the average of >= two blood-pressure readings) were allowed to use antihypertensive treatment to achieve these parameters. He had a history of hypertensive crisis or hypertensive encephalopathy. 17.Patients with innate or acquired immune deficiency (e.g., HIV infection). 18.Known allergy to the study drug or excipients or drug class. 19.Other factors considered unsuitable for participation in this study by the investigator.

研究实施时间：

Study execute time：

从 From 2026-04-30 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-04-30 00:00:00 至 To 2027-12-31 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

48

Group：

Experimental group

Sample size：

干预措施：

接受吉卡昔替尼治疗

干预措施代码：

Intervention：

Receive treatment with gicicitini

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 重庆市 

市(区县)：

  

Country：

China 

Province：

Chongqing 

City：

 

单位(医院)：

中国人民解放军陆军军医大学第一附属医院 

单位级别：

三级甲等 

Institution
hospital：

The First Affiliated Hospital of the Army Medical University of the People's Liberation Army of China

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

总生存期

指标类型：

次要指标

Outcome：

Overall survival（OS）

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：

主要指标

Outcome：

Objective 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：

无进展生存期

指标类型：

主要指标

Outcome：

Progression-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：

安全性与耐受性

指标类型：

次要指标

Outcome：

Safety and tolerability

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：

During of 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：

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：

疾病缓解时间

指标类型：

主要指标

Outcome：

Time to remission

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生活质量评分

指标类型：

次要指标

Outcome：

Quality of life（QoL）

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：

粪便

组织：

Sample Name：

Feces

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：

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 80 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

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：

使用EDC系统采集和管理数据

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

Data were collected and managed using an EDC system

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-04-27 11:15:26