A Phase II Trial of Hypofractionated Radiotherapy Combined With Thymosin for Metastatic NSCLC Patients Who Showed Stable Disease After First Line TKI Therapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The proportion of patients with an abscopal response assessed at 1-6 months after the radiation therapy
研究概览
简要总结
The investigators postulated that the exploitation of the pro-immunogenic effects of radiotherapy with thymosin might result in abscopal responses among patients with metastatic cancer. The research is designed to evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy combined with thymosin alpha 1. An exploratory biomarker analysis in blood and tumor samples is also planned.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed metastatic lung adenocarcinoma harboring sensitizing EGFR mutations (L858R, exon 19 deletion), and showed stable disease after 3 months TKI, evaluated twice by PET/CT scan, brain MRI, and abdomen ultrasound (≥3 measurable lesions, and these lesions haven't received local therapy)
- •Age 18 years or older
- •ECOG Performance Status 0-2
- •Adequate bone marrow, liver and renal function, as specified below: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L; Hemoglobin ≥ 8 g/dL; Platelets ≥ 100 x 109/L; Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) ; AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present; Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal
- •For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment
- •Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter
- •Patients and their family signed the informed consents
排除标准
- •Received chemotherapy before TKI therapy
- •Brain parenchyma or leptomeningeal disease
- •Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment
- •Any medical co-morbidities that would preclude radiation therapy.
研究组 & 干预措施
1
After 3 mos TKI, patients showed stable disease take TKI, radiotherapy and thymosin alpha 1 till tumor progression.
干预措施: TKI (Drug)
1
After 3 mos TKI, patients showed stable disease take TKI, radiotherapy and thymosin alpha 1 till tumor progression.
干预措施: Thoracic Hypofractionated Radiotherapy (Radiation)
1
After 3 mos TKI, patients showed stable disease take TKI, radiotherapy and thymosin alpha 1 till tumor progression.
干预措施: Thymosin Alpha 1 (Drug)
结局指标
主要结局
The proportion of patients with an abscopal response assessed at 1-6 months after the radiation therapy
时间窗: 1-6 months
To assess the proportion of patients with an abscopal response (defined as at least a 30% decrease in the longest diameter of the best responding abscopal lesion) at 1-6 months after the radiation therapy
次要结局
- To assess the short-term quality of life (QOL)(4 months)
- Rate of CTCAE grade 2 or higher radiation pneumonitis(1 years)
- Overall Survival(2 years)