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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | After 3 mos TKI, patients showed stable disease take TKI, radiotherapy and thymosin alpha 1 till tumor progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TKI | Drug | Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid |
|
| Measure | Description | Time Frame |
|---|---|---|
| The 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 | 1-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the short-term quality of life (QOL) | FACT-E score at the 4 months after docetaxel consolidation therapy | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shenglin Ma, MD | Contact | 0571-56007908 | 086 | mashenglin@medmail.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou First People's Hospital | Recruiting | Hangzhou | Zhejiang | 310006 | China |
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| Thoracic Hypofractionated Radiotherapy | Radiation | 40-45 Gy/5-15f |
|
| Thymosin Alpha 1 | Drug | Initiating thymosin alpha 1 therapy(1.6mg, qd, d1-d14;1.6mg, biw, d15-d90) at the second week of radiotherapy. |
|
|
| 1 years |
| Overall Survival | 2 years |
| ID | Term |
|---|---|
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| D000077596 | Thymalfasin |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013947 | Thymosin |
| D013951 | Thymus Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D036361 | Peptide Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
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