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Efficacy and Safety of High-Dose Rate Brachytherapy With Immunotherapy and Chemotherapy as Second-Line Treatment for Advanced Non-Small Cell Lung Cancer
Sponsor: The First People's Hospital of Neijiang
Summary
This is a single-center, retrospective, propensity score-matched study exploring the efficacy and safety of high-dose rate (HDR) brachytherapy combined with immune checkpoint inhibitors (ICIs) and chemotherapy as a second-line treatment for advanced non-small cell lung cancer (NSCLC). The study will compare two groups: Study group: HDR brachytherapy (30Gy single fraction) + ICIs (pembrolizumab) + chemotherapy (docetaxel) Control group: ICIs (pembrolizumab) + chemotherapy (docetaxel) alone Primary objective: To assess the objective response rate (ORR) Secondary objectives: To evaluate progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety. The study aims to address the unmet clinical need for effective treatments in advanced NSCLC patients who have progressed after immunotherapy. It will investigate whether the addition of HDR brachytherapy to immunotherapy and chemotherapy can improve treatment outcomes. This research is significant as it explores a novel treatment combination, potentially offering new options for second-line treatment of advanced NSCLC. It also aims to contribute to the understanding of how radiotherapy doses affect immunotherapy responses and may help identify biomarkers for treatment response prediction.
Official title: Exploring the Efficacy and Safety of High-Dose Rate Brachytherapy Combined With Immunotherapy and Chemotherapy as a Second-Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer: A Single-Center, Retrospective, Propensity Score-Matched Study
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
OBSERVATIONAL
Enrollment
80
Start Date
2023-09-01
Completion Date
2025-09-01
Last Updated
2024-07-24
Healthy Volunteers
No
Interventions
HDR brachytherapy (30Gy single fraction)
Study Group receives a novel triple combination therapy for advanced NSCLC in the second-line setting. The treatment begins with a single fraction of high-dose rate (HDR) brachytherapy, delivering 30 Gy locally to the tumor site. This is followed within 1-3 days by systemic therapy, combining immunotherapy and chemotherapy , both administered intravenously.
Immunotherapy
Control Group receives the current standard of care for second-line treatment of advanced NSCLC. This regimen consists of a combination of immunotherapy and chemotherapy , both administered intravenously
Locations (1)
The Second People's Hospital of Neijiang
Neijiang, Sichuan, China