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
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 166
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;