NCT05544149Unknown2 期
An Open-label, Phase II Single Arm Trial of Thoracic Radiotherapy for?ES-SCLC After First Line Treatment With Immune Checkpoint Inhibitors
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
To Evaluate the Safety and Efficacy of Thoracic Radiotherapy for?ES-SCLC After First Line Treatment with Immune Checkpoint Inhibitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at least 18 years.
- •ECOG PS 0-
- •Histological or cytological syndrome of small cell lung cancer, imaging evaluation staging is extensive
- •Life expectancy >= 3 months.
- •Patients are non-progressed after 4 dosed of immunotherapy plus platinum based chemotherapy, with residual thoracic lesions
- •Palliative radiotherapy were allowed except for TRT, the interval > 4 weeks
- •Adequate organ function prior to enrollment:
- •Adequate bone marrow function: white blood cell (WBC) count ≥ 3.0 * 10 ^ 9/L or neutrophil count ≥ 1.5 * 10 ^ 9/L, platelet count ≥ 100 * 10 ^ 9/L and hemoglobin ≥90g/L,;
- •Adequate hepatic function: total bilirubin, urea nitrogen and serum creatinine≤ 1.5 x upper limit of normal (ULN). Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.0 ULN;
- •Sufficient heart and lung function, EF>55%FEV1>50%
- •Ability to understand and willingness to provide the informed consent.
- •Women of childbearing age and men must agree to use effective contraception during the trial.
排除标准
- •History of another malignancy or concurrent malignancy;
- •Mixed small cell with non-small cell lung cancer histology;
- •History of thoracic radiotherapy;
- •Malignant pleural or ascites;
- •Patients with leptomeningeal metastasis or uncontrolled brain;
- •Severe autoimmune disease: inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Wegener's granulomatosis and related vasculitides.
- •Symptomatic interstitial lung disease or clinically active infectious/non-infectious pneumonitis.
- •Active infection, congestive heart failure, or any evidence of myocardial infarction, unstable angina pectoris or cardiac arrhythmia within 6 months prior to enrollment.
- •The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.
- •Mental disorders, drug abuse, and social condition that may negatively impact compliance in the investigator's opinion.
研究组 & 干预措施
TRT
Experimental
Patients with es-SCLC after first line treatment with immune checkpoint inhibitors will be treated with thoracic radiotherapy.
干预措施: Thoracic radiotherapy (Radiation)
结局指标
主要结局
Adverse events
时间窗: 2 years
Treatment-related adverse events according to CTCAE 5.0.
Local recurrence free survival
时间窗: 2 years
From the date of enrollment to the date of local recurrence
次要结局
- Overall survival(2 years)
- Progress free survival(2 years)
研究者
Xiaojing Lai
Clinical Professor
Zhejiang Cancer Hospital
研究点 (1)
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