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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid
40-45 Gy/5-15f
Initiating thymosin alpha 1 therapy(1.6mg, qd, d1-d14;1.6mg, biw, d15-d90) at the second week of radiotherapy.
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
RECRUITINGThe proportion of patients with an abscopal response assessed at 1-6 months after the radiation therapy
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
Time frame: 1-6 months
To assess the short-term quality of life (QOL)
FACT-E score at the 4 months after docetaxel consolidation therapy
Time frame: 4 months
Rate of CTCAE grade 2 or higher radiation pneumonitis
The investigators will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy
Time frame: 1 years
Overall Survival
Time frame: 2 years
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