Stage IV Lung Squamous Cell Carcinoma Treated With or Without Bronchial Artery Chemoembolization After First-line Chemotherapy and Immunotherapy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Препарат 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.

Первичные конечные точки

• Progression-free survival [Срок оценки: 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.]

Вторичные конечные точки (3)

• Overall Survival [Срок оценки: From date of randomization until the date of death from any cause, 6,12, 24 months or more, through study completion.]
• Objective response rate [Срок оценки: 2, 4, 6 months after the first Immunotherapy/BACE treatment, up to death or 24 months]
• Disease control rate [Срок оценки: 2, 4, 6 months after the first Immunotherapy/BACE treatment, up to death or 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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: adenoca

Идентификаторы

NCT: NCT07567313 · UHCT250797

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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