Overview
To evaluate the efficacy and toxicity of sodium glycididazole combined with concurrent chemoradiotherapy in patients with unresectable locally advanced non-small cell lung cancer after neoadjuvant chemoradiotherapy.
Description
- To evaluate the efficacy and toxicity of concurrent chemoradiotherapy combined with sodium glycididazole in patients with unresectable locally advanced non-small cell lung cancer after neoadjuvant chemoradiotherapy, and to explore sodium glycididazole as a new way to inhibit the occurrence of radiation esophagitis and reduce the occurrence of radiation pneumonitis and lymphopenia.
- To evaluate the sensitization effect of sodium glycididazole in the anti-tumor activity during concurrent chemoradiotherapy, as well as the changes in the anti-tumor immune response in peripheral blood, in order to screen out the dominant population and the predictive biomarkers with fewer related toxic and side effects.
- By exploring the correlation between the expression level of NLRP3 inflammasome activation related molecules and imaging changes in peripheral blood after radiotherapy and the toxicity of radiotherapy and chemotherapy, a risk model for predicting radiation esophagitis after concurrent radiotherapy and chemotherapy for non-small cell lung cancer was further constructed.
Eligibility
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed non-small cell lung cancer.
- Patients with unresectable stage II-III non-small cell lung cancer after neoadjuvant therapy.
- ECOG PS 0-2
- Adequate organ and bone marrow function.
Exclusion Criteria:
- History of previous radiotherapy.
- The previous immune-related pneumonitis ≥ grade 2.
- Local lesions require surgery.
- History of another primary malignancy.
- History of active primary immunodeficiency.
- Histological findings showed mixed small cell lung cancer and non-small cell lung cancer.
- For any unmitigated toxicity during pre-study chemoradiotherapy.