Stage IV Lung Squamous Cell Carcinoma Treated With or Without Bronchial Artery Chemoembolization After First-line Chemotherapy and Immunotherapy
Prospective, Multicenter, Open-label, Randomized Controlled Clinical Study of Patients With Stage IV Lung Squamous Cell Carcinoma Treated With or Without Bronchial Artery Chemoembolization After First-line Chemotherapy and Immunotherapy
This study intends to carry out prospective, randomized controlled clinical trials in many centers across the country to compare the efficacy and safety of immunotherapy after standard first-line chemotherapy or immunotherapy combined with interventional bronchial artery chemoembolization for stage IV lung squamous cell carcinoma.
研究概览
地位
尚未招聘
条件
详细说明
This study aimed to evaluate the differences in efficacy (e.g., progression-free survival, overall survival, objective response rate, and incidence of adverse events) and safety (e.g., incidence of adverse events) between tislelizumab therapy combined with 1-3 cycles of bronchial artery chemoembolization (with gemcitabine) and tislelizumab monotherapy in patients with stage IV squamous cell lung cancer who achieved partial remission or disease stabilization after standard first-line treatment (carboplatin + paclitaxel chemotherapy + tislelizumab immunotherapy, 4-6 cycles).
The goal was to explore ways to optimize first-line treatment strategies and further improve the overall efficacy of first-line treatment for patients with advanced squamous cell lung cancer.
研究类型
介入性
注册 (估计的)
166
阶段
- 第四阶段
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Squamous cell carcinoma of the lung confirmed by histology or cytology;
- According to the TNM staging system of the 9th edition of American Cancer Association, it was assessed as stage IV.
- Has received standard first-line chemotherapy immunotherapy for 4~6 cycles, and achieved partial remission or disease stability according to the efficacy evaluation of RECIST1.1;
- The patient is 18-80 years old;
- ECOG PS score is 0-1;
- The main organ functions meet the following criteria: (1) Blood routine examination: hemoglobin (HB) ≥ 90g/L; Leukocyte (ANC) ≥ 3.0× 109/L; Neutrophils ≥ 1.5× 109/L; Platelet (PLT) ≥ 75× 109/L; (2) Biochemical examination: albumin (ALB)≥29g/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2uln; Total bilirubin (TBIL) ≤ 1.5 ULN; Creatinine ≤ 1.5 ULN;
- Patients and/or their families agree to participate in clinical trials and sign informed consent forms;
- No history of other malignant tumors;
- No active infection;
- Be able to cooperate with research follow-up;
- At least one measurable lesion (according to RECIST 1.1);
- The expected survival time is more than 3 months.
Exclusion Criteria:
- There is epidermal growth factor receptor (EGFR) sensitive mutation or anaplasticlymphomakinase (ALK) gene translocation;
- Have a history of allergy to contrast agents or chemotherapy drugs;
- Received other anti-tumor treatments other than standard first-line chemotherapy immunotherapy;
- Arrhythmia with myocardial ischemia or myocardial infarction above grade II and poor control (including QTc interval ≥450ms for men and ≥ 470 ms for women);
- Coagulation function is seriously abnormal and cannot be corrected;
- Hypertension patients still have poor blood pressure control (systolic blood pressure > >160mmHg, diastolic blood pressure > 100 mmhg) after antihypertensive drugs treatment;
- Pregnant or lactating female patients;
- Have a history of mental illness or psychotropic drug abuse;
- Patients with symptomatic brain metastasis;
- Patients with autoimmune diseases;
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Immunotherapy group
|
Tislelizumab 200 mg, IV infusion, Q3W, maintenance for 2 years.
Follow up with enhanced CT scans of the lungs and mediastinum every 4-6 weeks, and assess efficacy according to RECIST 1.1 criteria.
|
|
实验性的：Immunotherapy combined with interventional therapy group
|
Tislelizumab 200mg, intravenous infusion, every 3 weeks, for 2 years.
Simultaneously, the patient undergoes 1-3 sessions of transbronchial chemoembolization (BACE).
A follow-up enhanced CT scan of the lungs and mediastinum is performed 4-6 weeks after BACE.
Based on the results, the investigator will assess whether further BACE is necessary, with a maximum of 3 BACE sessions per patient.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Progression-free survival
大体时间：From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
|
From date of randomization until the date of first documented progression or date of death from any cause
|
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival
大体时间：From date of randomization until the date of death from any cause, 6,12, 24 months or more, through study completion.
|
From date of randomization until the date of death from any cause
|
From date of randomization until the date of death from any cause, 6,12, 24 months or more, through study completion.
|
|
Objective response rate
大体时间：2, 4, 6 months after the first Immunotherapy/BACE treatment, up to death or 24 months
|
Proportion of patients with reduction in stable in tumor burden of a predefined amount
|
2, 4, 6 months after the first Immunotherapy/BACE treatment, up to death or 24 months
|
|
Disease control rate
大体时间：2, 4, 6 months after the first Immunotherapy/BACE treatment, up to death or 24 months
|
Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount
|
2, 4, 6 months after the first Immunotherapy/BACE treatment, up to death or 24 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 1. Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2024, 74(3): 229-263. 2. Lortet-Tieulent J, Soerjomataram I, Ferlay J, Rutherford M, Weiderpass E, Bray F. International trends in lung cancer incidence by histological subtype: adenocarcinoma stabilizing in men but still increasing in women. Lung Cancer 2014, 84(1): 13-22. 3. Cheng TY, Cramb SM, Baade PD, Youlden DR, Nwogu C, Reid ME. The International Epidemiology of Lung Cancer: Latest Trends, Disparities, and Tumor Characteristics. J Thorac Oncol 2016, 11(10): 1653-1671. 4. Socinski MA, Obasaju C, Gandara D, Hirsch FR, Bonomi P, Bunn PA, Jr., et al. Current and Emergent Therapy Options for Advanced Squamous Cell Lung Cancer. J Thorac Oncol 2018, 13(2): 165-183. 5. He G, Yang K, Zhang X, Pan J, Han A, Gao Z, et al. Bronchial artery chemoembolization with drug-eluting beads versus bronchial artery infusion followed by polyvinyl alcohol particles embolization for advanced squamous cell lung cancer: A retrospective study. Eur J Radiol 2023, 161: 110747. 6. Network NCC. Non-small cell lung cancer (version 4.2025). 2025. 7. Lu S, Chen Z, Hu C, Zhang J, Chen Y, Song Y, et al. Nedaplatin Plus Docetaxel Versus Cisplatin Plus Docetaxel as First-Line Chemotherapy for Advanced Squamous Cell Carcinoma of the Lung - A Multicenter, Open-label, Randomized, Phase III Trial. J Thorac Oncol 2018, 13(11): 1743-1749. 8. Novello S, Kowalski DM, Luft A, Gumus M, Vicente D, Mazieres J, et al. Pembrolizumab Plus Chemotherapy in Squamous Non-Small-Cell Lung Cancer: 5-Year Update of the Phase III KEYNOTE-407 Study. J Clin Oncol 2023, 41(11): 1999-2006.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年4月20日
初级完成 (估计的)
2028年1月1日
研究完成 (估计的)
2028年6月30日
研究注册日期
首次提交
2026年4月2日
首先提交符合 QC 标准的
2026年5月3日
首次发布 (实际的)
2026年5月5日
研究记录更新
最后更新发布 (实际的)
2026年5月5日
上次提交的符合 QC 标准的更新
2026年5月3日
最后验证
2026年1月1日
更多信息
与本研究相关的术语
其他研究编号
- UHCT250797
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
IPD 计划说明
Involving patient privacy
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.