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：	ChiCTR2500097454
最近更新日期： Date of Last Refreshed on：	2025-02-19 14:42:36
注册时间： Date of Registration：	2025-02-19 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	硼替佐米联合替雷利珠单抗治疗IIIB-IV期肺鳞状细胞癌的前瞻性、单中心、探索性临床研究
Public title：	Prospective, single-center, exploratory clinical study of bortezomib combined with Tirellizumab in the treatment of stage IIIB-IV lung squamous cell carcinoma
注册题目简写：
English Acronym：
研究课题的正式科学名称：	硼替佐米联合替雷利珠单抗治疗IIIB-IV期肺鳞状细胞癌的前瞻性、单中心、探索性临床研究
Scientific title：	Prospective, single-center, exploratory clinical study of bortezomib combined with Tirellizumab in the treatment of stage IIIB-IV lung squamous cell 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：	徐嵩	研究负责人：	徐嵩
Applicant：	Song Xu	Study leader：	Song Xu
申请注册联系人电话： Applicant telephone：	+86 135 1229 1626	研究负责人电话： Study leader's telephone：	+86 135 1229 1626
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：	xusong198@hotmail.com	研究负责人电子邮件： Study leader's E-mail：	xusong198@hotmail.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 Distritct, Tianjin, China	Study leader's address：	154 Anshan Road, Heping Distritct, 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
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	IRB2024-YX-646-01	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：	Medical Ethics Committee of Tianjin Medical University General Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2024-12-26 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 Distritct, Tianjin, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 60361044	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 Distritct, 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)：
Country：	China	Province：	Tianjin	City：
单位(医院)：	天津医科大学总医院	具体地址：	和平区鞍山道154号
Institution hospital：	Tianjin Medical University General Hospital	Address：	154 Anshan Road, Heping Distritct

经费或物资来源：

自筹

Source(s) of funding：

Self-financing

研究疾病：

肺鳞状细胞癌

Target disease：

Lung squamous cell carcinoma

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：

其它

Study phase：

N/A

研究设计：

单臂

Study design：

Single arm

研究目的：

评估经硼替佐米联合替雷利珠单抗治疗IIIB-IV期肺鳞状细胞癌患者持续应用的疗效和安全性，观察患者的客观缓解率和疾病控制率

Objectives of Study：

To evaluate the efficacy and safety of bortezomib combined with tirelizumab in the treatment of patients with stage IIIB-IV lung squamous cell carcinoma, and analyze the objective response rate and disease control rate of patients

药物成份或治疗方案详述：

试验用药：硼替佐米、替雷利珠单抗 1.入选研究的患者于每个治疗周期第1天及第4天给予硼替佐米单次皮下注射1.0mg/m2；替雷利珠单抗200mg于第1天静脉滴注，每三周为一个治疗周期; 2.两个周期治疗后进行评估（根据RECIST1.1标准）。疾病进展患者出组；无疾病进展的患者继续进行两个周期治疗; 3.经过4周期治疗的患者进行第二次评估。疾病进展的患者出组，疾病稳定患者进行替雷利珠单抗维持行治疗，直至疾病进展、死亡或长达2年。

Description for medicine or protocol of treatment in detail：

Experimental drugs: Bortezomib, Tislelizumab 1. Patients enrolled in the study will receive a single subcutaneous injection of bortezomib at a dose of 1.0 mg/m2 on day 1 and day 4 of each treatment cycle; tislelizumab 200 mg will be administered intravenously on day 1. Each treatment cycle lasts for three weeks. 2. An assessment will be conducted after two treatment cycles (based on RECIST 1.1 criteria). Patients with disease progression will be withdrawn from the study; those without disease progression will continue for two more treatment cycles. 3. A second assessment will be carried out for patients who have completed four treatment cycles. Patients with disease progression will be withdrawn from the study. Patients with stable disease will receive maintenance treatment with tislelizumab until disease progression, death, or up to two years.

纳入标准：

Inclusion criteria

1. Male and female patients aged >= 18 years.
2. Histologically confirmed lung squamous cell carcinoma (requiring biopsy or bronchoscopy):
(1) Diagnostic biopsy or bronchoscopy results must be diagnosed by a specialist pathologist.
(2) Tumor biopsy samples can be formalin-fixed tissue blocks or 10 5μm tissue sections, which will be used for biomarker assessment (the pathologist must confirm that the samples are sufficient). These can be preserved samples, and new biopsies can be performed if necessary.
(3) Locally advanced (IIIB stage) or metastatic (IV stage) disease (AJCC 8th).
3. At least one measurable tumor lesion (according to RECIST 1.1 criteria).
4. Patients who refused chemotherapy or were intolerant to chemotherapy during first-line treatment, or failed after first-line or multiple lines of treatment.
5. ECOG performance score 0-1.
6. Good organ function:
(1) White blood cells >= 2000/mm^3
(2) Absolute neutrophil count (ANC) >= 1000/mm^3
(3) Platelet count >=100000/mm^3
(4) Hemoglobin >= 9g/dL
(5) Creatinine <= 2.0mg/dL
(6) Total bilirubin within the normal range of the institution (except for subjects with Gilbert's syndrome, whose total bilirubin is generally < 3.0 mg/dL)
(7) AST (SGOT), ALT (SGPT), and alkaline phosphatase <= 2.5 times the upper limit of normal.
7. Patients understand the study protocol and its requirements, risks, and potential adverse reactions, and are able and willing to sign the informed consent form. Before performing any protocol-related procedures that are not part of normal patient care, a signed and dated written informed consent form approved by the ethics committee (IRB/IEC) in accordance with regulations and institutional guidelines must be obtained from the patient. Subjects must be capable of reporting adverse events (AE), understand the drug administration schedule, and use drugs to control adverse events.
8. Expected survival >= 12 weeks.
9. Patients voluntarily join this study, sign the informed consent form (ICF), have good compliance, and cooperate with follow-up.

排除标准：

1.接受过免疫治疗。 2.有活动性、已知或疑似自身免疫性疾病。患有白癜风、I型糖尿病，由于自身免疫性甲状腺炎而仅需要激素替代的残留甲状腺功能减退症，或者在没有外部触发的情况下预期不会复发的病症的受试者被允许登记。需要在首次给药后14天内用皮质类固醇（每日＞10mg泼尼松当量）或其他免疫抑制药物进行全身治疗。在没有活动性自身免疫疾病的情况下，允许吸入或局部使用类固醇和肾上腺替代类固醇剂量。 3.排除具有活动性并发恶性肿瘤的受试者，即除肺鳞状细胞癌以外的癌症（非黑素瘤皮肤癌、原位膀胱癌、胃癌、乳腺癌、结肠癌或宫颈癌/发育不良除外）。 4.脑转移的受试者被排除在本研究之外，并且所有患者在入选之前应该进行脑成像（增强MRI脑成像或CT脑成像）。 5.需要治疗的活动性全身性感染，乙型肝炎表面抗原或丙型肝炎核糖核酸（RNA）的阳性检测。 6.有间质性肺病史的受试者 7.有周围神经病变的患者 8.已知对硼或甘露醇有过敏史。 9.怀孕或哺乳的女性。 10.有高血压且经降压药物治疗无法降至正常范围内者（收缩压>140 mmHg，舒张压>90 mmHg）。 11.患有Ⅱ级以上或控制不良的心血管疾病。 12.患者在入组前 3 年内接受过其他癌症治疗，基底细胞癌或宫颈原位癌除外。

Exclusion criteria：

1. Patients have received immunotherapy. 2. Patients have active, known or suspected autoimmune disease. Subjects with vitiligo, type 1 diabetes, hypothyroidism requiring only hormone replacement due to autoimmune thyroiditis, or conditions not expected to recur without external triggers are allowed to register. Systemic treatment with corticosteroids (more than 10mg prednisone equivalent daily) or other immunosuppressive drugs within 14 days of the first dose is excluded. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement steroids are allowed. 3. Patients with active concurrent malignancies, except for lung squamous cell carcinoma (excluding non-melanoma skin cancer, carcinoma in situ of the bladder, gastric cancer, breast cancer, colon cancer or cervical cancer/dysplasia), are excluded. 4. Patients with brain metastases are excluded from this study, and all patients should undergo brain imaging (enhanced MRI brain imaging or CT brain imaging) before enrollment. 5. Patients with active systemic infections requiring treatment, positive tests for hepatitis B surface antigen or hepatitis C RNA. 6. Patients with a history of interstitial lung disease. 7. Patients with peripheral neuropathy. 8. Known allergy to boron or mannitol. 9. Pregnant or lactating women. 10. Patients with hypertension that cannot be controlled within the normal range by antihypertensive drugs (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg). 11. Patients with grade II or higher or poorly controlled cardiovascular disease. 12. Patients who have received other cancer treatments within 3 years before enrollment, except for basal cell carcinoma or cervical carcinoma in situ.

研究实施时间：

Study execute time：

从 From 2025-03-01 00:00:00至 To 2028-03-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-03-01 00:00:00 至 To 2028-03-01 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	10
Group：	Experimental group	Sample size：	10
干预措施：	硼替佐米联合替雷利珠单抗治疗	干预措施代码：
Intervention：	Bortezomib combined with tirellizumab therapy	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	天津	市(区县)：
Country：	China	Province：	Tianjin	City：
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

测量指标：

Outcomes：

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：	疾病控制率	指标类型：	主要指标
Outcome：	Disease control 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：	安全性	指标类型：	主要指标
Outcome：	safety	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：	次要指标
Outcome：	Progression 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：	肿瘤组织	组织：
Sample Name：	Tumor tissue	Tissue：
人体标本去向	使用后保存	说明
Fate of sample：	Preservation 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：

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）：	数据公开实际时间需根据研究完成时间调整。公开方式为在国际/国内学术会议上公开数据结果
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	The data will be released according to the completion time of the study. The data will be released at international / domestic academic conferences.
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。研究结果数据将在研究结束后半年内公布于临床试验公共管理平台（http://www.medresman.org.cn）
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Electronic Data Capture,EDC. The results of the study data will be announced within the next six months at the end of the study in Clinical Trial Management Public Platform (http://www.medresman.org.cn)
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2025-02-19 14:42:31