Radiotherapy Combined With Thymosin for Metastatic NSCLC Patients Who Showed Stable Disease After First Line TKI Therapy
NCT02787447 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2016-11-25
Summary
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.
Conditions
Interventions
- DRUG
-
TKI
Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid
- RADIATION
-
Thoracic Hypofractionated Radiotherapy
40-45 Gy/5-15f
- DRUG
-
Thymosin Alpha 1
Initiating thymosin alpha 1 therapy(1.6mg, qd, d1-d14;1.6mg, biw, d15-d90) at the second week of radiotherapy.
Sponsors & Collaborators
-
First People's Hospital of Hangzhou
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-05-31
- Primary Completion
- 2017-12-31
- Completion
- 2020-05-31
Countries
- China
Study Locations
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