Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518018
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-13
Brief Title:
Efficacy and Safety of High-Dose Rate Brachytherapy with Immunotherapy and Chemotherapy As Second-Line Treatment for Advanced Non-Small Cell Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIBIC-NSCLC
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
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 181 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
Secondary To assess progression-free survival PFS overall survival OS disease control rate DCR and safety of the combination therapy
Study Design
This is a single-center retrospective propensity score-matched study comparing two treatment approaches
Study group HDR brachytherapy ICIs chemotherapy Control group ICIs chemotherapy alone
Treatment Protocol
Study group Patients will receive HDR brachytherapy 30Gy single fraction followed by pembrolizumab and docetaxel chemotherapy within 1-3 days
Control group Patients will receive pembrolizumab and docetaxel chemotherapy without brachytherapy
Key Scientific Questions
Evaluate the potential improvement in second-line treatment efficacy for advanced NSCLC patients through the combination therapy
Investigate the mechanisms by which HDR brachytherapy enhances the effectiveness of ICIs and chemotherapy
Analyze the differential efficacy of the combination therapy across various subgroups of NSCLC patients
Rationale
Recent evidence suggests that radiotherapy can exert immunomodulatory effects potentially enhancing immune treatment responses High-dose radiotherapy has been shown to improve local control and survival rates in early-stage NSCLC when combined with immunotherapy This study extends this concept to advanced NSCLC as a second-line treatment option
Significance
This research addresses a critical gap in current treatment options for advanced NSCLC patients who have progressed after immunotherapy It aims to
Improve patient outcomes in terms of quality of life and survival Advance scientific understanding of the interaction between radiotherapy and immunotherapy
Explore potential biomarkers for treatment response prediction Contribute to the development of more personalized treatment strategies in oncology
Innovation
This is the first study to investigate HDR brachytherapy combined with ICIs and chemotherapy for previously treated advanced NSCLC patients The novel combination strategy shows potential for improved efficacy and safety offering new options for second-line treatment of advanced NSCLC
Expected Outcomes
The study aims to demonstrate improved ORR PFS and OS in the combination therapy group compared to the control group It also seeks to establish the safety profile of the combination therapy and identify patient subgroups that may benefit most from this approach
Conclusion
This study represents a significant step towards addressing the unmet needs of advanced NSCLC patients who have progressed after initial treatment By exploring this innovative combination therapy the research aims to contribute valuable insights to the field of oncology and potentially improve treatment outcomes for this challenging patient population
Background
Non-small cell lung cancer NSCLC is a significant health concern in China accounting for approximately 181 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
Secondary To assess progression-free survival PFS overall survival OS disease control rate DCR and safety of the combination therapy
Study Design
This is a single-center retrospective propensity score-matched study comparing two treatment approaches
Study group HDR brachytherapy ICIs chemotherapy Control group ICIs chemotherapy alone
Treatment Protocol
Study group Patients will receive HDR brachytherapy 30Gy single fraction followed by pembrolizumab and docetaxel chemotherapy within 1-3 days
Control group Patients will receive pembrolizumab and docetaxel chemotherapy without brachytherapy
Key Scientific Questions
Evaluate the potential improvement in second-line treatment efficacy for advanced NSCLC patients through the combination therapy
Investigate the mechanisms by which HDR brachytherapy enhances the effectiveness of ICIs and chemotherapy
Analyze the differential efficacy of the combination therapy across various subgroups of NSCLC patients
Rationale
Recent evidence suggests that radiotherapy can exert immunomodulatory effects potentially enhancing immune treatment responses High-dose radiotherapy has been shown to improve local control and survival rates in early-stage NSCLC when combined with immunotherapy This study extends this concept to advanced NSCLC as a second-line treatment option
Significance
This research addresses a critical gap in current treatment options for advanced NSCLC patients who have progressed after immunotherapy It aims to
Improve patient outcomes in terms of quality of life and survival Advance scientific understanding of the interaction between radiotherapy and immunotherapy
Explore potential biomarkers for treatment response prediction Contribute to the development of more personalized treatment strategies in oncology
Innovation
This is the first study to investigate HDR brachytherapy combined with ICIs and chemotherapy for previously treated advanced NSCLC patients The novel combination strategy shows potential for improved efficacy and safety offering new options for second-line treatment of advanced NSCLC
Expected Outcomes
The study aims to demonstrate improved ORR PFS and OS in the combination therapy group compared to the control group It also seeks to establish the safety profile of the combination therapy and identify patient subgroups that may benefit most from this approach
Conclusion
This study represents a significant step towards addressing the unmet needs of advanced NSCLC patients who have progressed after initial treatment By exploring this innovative combination therapy the research aims to contribute valuable insights to the field of oncology and potentially improve treatment outcomes for this challenging patient population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None