ChiCTR2500104633 版本V1.0 版本创建时间2025/06/19 17:51:42 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：

ChiCTR2500104633 

最近更新日期：

Date of Last Refreshed on：

2025-06-19 17:51:32 

注册时间：

Date of Registration：

2025-06-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

替雷利珠单抗治疗口腔白斑病及口腔红斑病的单臂、开放、前瞻性临床研究

Public title：

A single-arm, open, prospective clinical study of tislelizumab in the treatment of oral leukoplakia and oral erythema

注册题目简写：

English Acronym：

研究课题的正式科学名称：

替雷利珠单抗治疗口腔白斑病及口腔红斑病的单臂、开放、前瞻性临床研究

Scientific title：

A single-arm, open, prospective clinical study of tislelizumab in the treatment of oral leukoplakia and oral erythema

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：

彭星辰 

研究负责人：

彭星辰 

Applicant：

Xingchen Peng 

Study leader：

Xingchen Peng 

申请注册联系人电话：

Applicant telephone：

+86 28 85421141

研究负责人电话：

Study leader's telephone：

+86 28 85421141

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：

pxx2014@163.com

研究负责人电子邮件：

Study leader's E-mail：

pxx2014@scu.ed.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：

四川省成都市武侯区国学巷37号

研究负责人通讯地址：

四川省成都市武侯区国学巷37号

Applicant address：

No. 37, Guoxue Lane, Wuhou District, Chengdu, Sichuan Province

Study leader's address：

No. 37, Guoxue Lane, Wuhou District, Chengdu, Sichuan Province

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：

四川大学华西医院

Applicant's institution：

West China Hospital , Sichuan University,

研究负责人所在单位：

四川大学华西医院

Affiliation of the Leader：

West China Hospital of Sichuan University

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：

2024年审（2433）号

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：

四川大学华西医院生物医学伦理审查委员会

Name of the ethic committee：

Ethics Committee on Biomedical Research West China Hospital of Sichuan University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-02-19 00:00:00

伦理委员会联系人：

李娜

Contact Name of the ethic committee：

Li Na

伦理委员会联系地址：

四川省成都市武侯区国学巷37号

Contact Address of the ethic committee：

No. 37, Guoxue Lane, Wuhou District, Chengdu, Sichuan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 28 85422654

伦理委员会联系人邮箱：

Contact email of the ethic committee：

188974152@qq.com

研究实施负责（组长）单位：

四川大学华西医院

Primary sponsor：

West China Hospital of Sichuan University

研究实施负责（组长）单位地址：

四川省成都市武侯区国学巷37号

Primary sponsor's address：

No. 37, Guoxue Lane, Wuhou District, Chengdu, Sichuan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

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

具体地址：

四川省成都市武侯区国学巷37号

Institution
hospital：

West China Hospital of Sichuan University

Address：

No. 37, Guoxue Lane, Wuhou District, Chengdu, Sichuan Province

经费或物资来源：

精准医学研究

Source(s) of funding：

National Key Research and Development Program of China

Target disease：

Oral leukoplakia and oral erythema

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：

评估替雷利珠单抗治疗口腔白斑病及口腔红斑病患者的疗效，主要通过治疗前后的病变面积和异型增生程度的变化  

Objectives of Study：

To evaluate the efficacy of tislelizumab in the treatment of patients with oral leukoplakia and oral erythema, mainly by measuring the change in lesion area and degree of dysplasia before and after treatment

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.签署书面知情同意书； 2.年龄在18岁及以上且小于80岁的男性和女性; 3.ECOG评分 0-2； 4.受试者必须有组织学证实的口腔白斑病、口腔红斑病或增殖性疣状白斑 （PVL）。其病变可在二维范围内测量，不适合手术切除，或拒绝手术。患者必须至少有 2 个病变，可以随访治疗。（接受过完全切除病变且临床上没有疾病证据的患者将不符合研究条件）； 5.基线活检标本可用于相关分析或愿意接受新的基线及治疗后活检； 6.能配合拍摄病损照片； 7.足够的器官和骨髓功能： a.血常规满足：白细胞>=3x10^9 /L；中性粒细胞> 1.5 x 10^9/L，血小板 > 100 x 10^9/L，血红蛋白> 9 g/dL ； b.肝功能满足：血清总胆红素（TBIL）<=2.0 g/dL，丙氨酸氨基转移酶（ALT）和天冬氨酸氨基转移酶（AST）<=2.5×ULN ； c.肾功能满足：肌酐在正常的范围内 ；肌酐水平高于正常值需肌酐清除率>=60ml /min/1.73 m^2； 8.有生育能力的女性受试者应在接受第一剂研究药物前 72 小时内尿或血清妊娠试验阴性。如果尿液检测呈阳性或无法确认为阴性，则需要进行血清妊娠试验； 9.有生育能力的女性受试者应愿意使用两种节育方法或手术绝育，或在研究过程中直至最后一次给药后5个月内避免性行为。“有生育能力的女性”定义为任何经历过月经初潮且未接受手术绝育(子宫切除术或双侧卵巢切除术)或未绝经的女性。绝经在临床上被定义为45岁以上女性在没有其他生物或生理原因的情况下闭经12个月。此外，55岁以下的女性必须有记录的血清促卵泡激素(FSH)水平低于40 mIU/mL； 10.男性受试者应同意使用失败率低于 1% 的任何避孕方法，从第一剂研究治疗开始直到最后一剂研究治疗后7个月内.

Inclusion criteria

1. Signed written informed consent; 2. Males and females aged 18 years and over and less than 80 years old; 3. ECOG score 0-2; 4. Subjects must have histologically confirmed oral leukoplakia, oral erythema, or proliferative verrucous leukoplakia (PVL). Lesions can be measured in a two-dimensional range, are not amenable to surgical resection, or refuse surgery. Patients must have at least 2 lesions that can be followed for treatment. (Patients who have undergone complete resection of the lesion and have no clinical evidence of disease will not be eligible for the study); 5. Baseline biopsy specimens can be used for relevant analysis or willing to undergo new baseline and post-treatment biopsies; 6. Able to cooperate in taking photos of lesions; 7. Adequate organ and bone marrow function: a. Routine blood count: leukocyte >=3x10^9/L; neutrophil > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 9 g/dL; b. Liver function satisfies the following: serum total bilirubin (TBIL) <=2.0 g/dL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5×ULN; c. Renal function is satisfied: creatinine is within the normal range; If the creatinine level is higher than the normal value, the creatinine clearance rate should be >=60ml/min/1.73 m^2; 8. Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study drug. If the urine test is positive or cannot be confirmed negative, a serum pregnancy test is required; 9. Female subjects of childbearing potential should be willing to use two methods of birth control or surgical sterilization, or abstain from sexual activity during the course of the study until 5 months after the last dose. "Female of childbearing potential" is defined as any woman who has experienced menarche and has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal. Menopause is clinically defined as 12 months of amenorrhea in women over the age of 45 without other biological or physiological causes. In addition, females under 55 years of age must have a documented serum follicle-stimulating hormone (FSH) level of less than 40 mIU/mL; 10. Male subjects should agree to use any method of contraception with a failure rate of less than 1% from the first dose of study treatment until 7 months after the last dose of study treatment.

排除标准：

1.已知的口腔原位癌或浸润性鳞状细胞癌。既往有III期(T1-2N1, T3N0)或IV期(T1-3N2, T4N0)侵袭性头颈部鳞状细胞癌，接受过手术和放疗，伴或不伴化疗。既往仅接受手术治疗的局部区域晚期肿瘤患者符合条件； 2.目前正在参加并接受其他研究治疗； 3.既往接受过免疫治疗（抗PD-1、抗PD-L1、抗PD-L2、抗CTLA-4抗体或任何其他特异性靶向T细胞共刺激或免疫检查点受体的抗体或药物）； 4.已知有人类免疫缺陷病毒 （HIV）（HIV 1/2 抗体）病史； 5.乙型肝炎病毒或丙型肝炎病毒的任何阳性检测结果表明存在病毒，例如乙型肝炎表面抗原（HBsAg）阳性，或丙型肝炎抗体（抗-HCV）阳性（HCV-RNA 阴性除外）； 6.有需要全身治疗的活动性感染或活动性结核； 7.临床上显着的心血管疾病，例如纽约心脏协会III-IV级心力衰竭，未控制的冠状动脉疾病，心肌病，未控制的心律失常，未控制的高血压或过去12个月内的心肌梗塞史； 8.活动性、已知或疑似自身免疫性疾病。除外患有治愈的儿童哮喘、I 型糖尿病和甲状腺功能减退症只需要激素替代的受试者，或不需要全身治疗的皮肤病（如白癜风、牛皮癣或脱发）； 9.既往诊断为免疫缺陷，或需要免疫抑制治疗的器官移植，或正在接受全身性类固醇治疗>泼尼松20mg/d（或等效物等效剂量），或在第一次试验治疗前7天内接受任何其他形式的免疫抑制治疗。在没有活动性自身免疫性疾病的情况下，允许吸入或外用类固醇、类固醇作为超敏反应的前用药或针对肾上腺或垂体功能不全的生理性皮质类固醇替代疗法； 10.严重的神经或精神疾病，药物滥用，会干扰研究进行； 11.其他可能损害患者参与研究能力的严重基础疾病； 12.在计划开始研究治疗后的 30 天内接种了活疫苗； 13.已知对治疗任何成分的过敏/超敏反应； 14.怀孕或哺乳，或预期在研究时间内怀孕或生育孩子（从预筛查开始直到最后一剂试验治疗后 7个月）； 15.已知有其他恶性肿瘤正在进展或需要积极治疗，但除外：皮肤基底细胞癌；宫颈原位癌；膀胱原位癌；乳腺原位癌；积极监测的低风险前列腺腺癌； 16.无法律行为能力或法律行为能力有限； 17.排除长期嚼槟榔（每日≥1次，持续一年以上）、当前吸烟或戒烟少于一年、过量饮酒（每周超过14个标准单位，或连续饮酒超过10年）、存在职业致癌暴露或口腔卫生较差的患者。 18.有治疗研究者认为其他可能混淆试验结果、干扰受试者在整个试验期间参与或不符合受试者参与的任何疾病、治疗或实验室异常的病史或证据.

Exclusion criteria：

1. Known carcinoma in situ or invasive squamous cell carcinoma of the oral cavity. Prior stage III (T1-2N1, T3N0) or stage IV (T1-3N2, T4N0) aggressive squamous cell carcinoma of the head and neck with surgery and radiation therapy, with or without chemotherapy. Patients with locoregional advanced tumors who have received prior surgery only are eligible; 2. Currently enrolled in and receiving other investigational treatments; 3. Prior immunotherapy (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint receptors); 4. Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies); 5. Any positive test result for hepatitis B virus or hepatitis C virus indicates the presence of the virus, such as hepatitis B surface antigen (HBsAg) positive, or hepatitis C antibody (anti-HCV) positive (except HCV-RNA negative); 6. Have active infection or active tuberculosis requiring systemic treatment; 7. Clinically significant cardiovascular disease, such as New York Heart Association Class III-IV heart failure, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction within the past 12 months; 8. Active, known, or suspected autoimmune disease. Subjects with cured childhood asthma, type I diabetes mellitus, and hypothyroidism requiring only hormone replacement are excluded, or skin conditions that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia); 9. Prior diagnosis of immunodeficiency, or organ transplantation requiring immunosuppressive therapy, or receiving systemic steroid therapy > prednisone 20mg/d (or equivalent dose), or receiving any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. In the absence of active autoimmune disease, inhaled or topical steroids, steroids as promedications for hypersensitivity reactions, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency are permitted; 10. Severe neurological or psychiatric disease, substance abuse, that would interfere with the conduct of the study; 11. Other serious underlying diseases that may impair the patient's ability to participate in the study; 12. Received a live vaccine within 30 days of planned initiation of study treatment; 13. Known allergic/hypersensitivity reaction to any ingredient of the treatment; 14. Pregnant or breastfeeding, or expecting to become pregnant or give birth to a child during the study time (from pre-screening until 7 months after the last dose of trial treatment); 15. Known to have other malignancies that are progressing or require active treatment, with the exception of: basal cell carcinoma of the skin; carcinoma in situ of the cervix; carcinoma in situ of the bladder; carcinoma in situ of the breast; low-risk prostate adenocarcinoma under active surveillance; 16. Lack of legal capacity or limited legal capacity; 17. Patients with long-term betel nut chewing (>= once a day for more than one year), current smoking or quitting smoking for less than one year, excessive alcohol consumption (more than 14 standard units per week, or continuous drinking for more than 10 years), occupational carcinogenic exposure, or poor oral hygiene were excluded. 18. Has a history or evidence of any other disease, treatment, or laboratory abnormality that, in the opinion of the treating investigator, may confound the results of the trial, interfere with the subject's participation throughout the trial period, or is inconsistent with the subject's participation.

研究实施时间：

Study execute time：

从 From 2025-07-01 00:00:00至 To 2028-07-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-07-01 00:00:00 至 To 2026-07-01 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

6

Group：

Experimental Group

Sample size：

干预措施：

替雷利珠单抗

干预措施代码：

Intervention：

Tislelizumab

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

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：

三级甲等 

Institution
hospital：

West China Hospital of Sichuan University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

给药前后口腔白斑和/或红斑部位测量值的变化

指标类型：

主要指标

Outcome：

Change in measurements of the site of oral leukoplakia and/or erythema before and after administration

Type：

Primary indicator

测量时间点：

治疗后6个月

测量方法：

Measure time point of outcome：

6 months after treatment

Measure method：

指标中文名：

不良反应

指标类型：

次要指标

Outcome：

Adverse effects

Type：

Secondary indicator

测量时间点：

整个研究过程

测量方法：

Measure time point of outcome：

The entire research process

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

病变组织

组织：

Sample Name：

Diseased tissue

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：

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 岁 years
最大 Max age 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：

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：

有/Yes

注册人：

Name of Registration：

  2025-06-19 17:51:32