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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 80
- Primary Endpoint
- Objective Response Rate (ORR)
Study Overview
Brief 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.
Detailed Description
Study 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
Background:
Non-small cell lung cancer (NSCLC) is a significant health concern in China, accounting for approximately 18.1% of new cancer cases in 2022. Despite advancements in targeted therapies and immunotherapies, patients with advanced NSCLC who progress after initial treatment face limited options and poor prognosis. This study aims to address this unmet clinical need by investigating a novel combination therapy.
Objectives:
Primary: To evaluate the objective response rate (ORR) of high-dose rate (HDR) brachytherapy combined with immune checkpoint inhibitors (ICIs) and chemotherapy in advanced NSCLC patients.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of advanced Non-Small Cell Lung Cancer (NSCLC),Likely stage IIIB-IV, though specific staging is not mentioned
- •Patients requiring second-line treatment Implying progression after first-line therapy
- •Age: Adults (specific age range not provided, but typically 18 years or older)
- •Presence of measurable disease according to RECIST v1.1 criteria
- •Adequate organ function (specific parameters not provided, but typically included in such studies)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (not explicitly stated, but common in similar studies)
Exclusion Criteria
- •Presence of targetable driver mutations (e.g., EGFR, ALK, ROS1, BRAF)
- •Prior treatment with HDR brachytherapy for the current disease
- •Contraindications to immunotherapy or chemotherapy
- •Severe comorbidities that would preclude safe administration of study treatments
- •Brain metastases, unless treated and stable (not explicitly stated, but common in similar studies)
- •Participation in another clinical trial with an investigational agent
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: Every 8 weeks from baseline up to 24 months or until disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurs first
The proportion of patients achieving either a complete response (CR) or partial response (PR) according to RECIST v1.1 criteria
Secondary Outcomes
- Progression-Free Survival (PFS)(Progression-Free Survival was assessed from the date of treatment initiation until the date of first documented disease progression or death from any cause, whichever occurred first, assessed up to 24 months.)
Investigators
Ou Jiang
Chief of Cancer Center
Neijiang No.2 People's Hospital