Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636591
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Open-label Single-center Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
In this study breast cancer BC patients eligible for inclusion will be divided into two groups according to molecular typing and subtyping which combined immunotherapy and multimodal thermal therapy with conventional neoadjuvant chemotherapy to explore methods of immune induction for BC enhance the efficacy of immunotherapy and accumulate data for subsequent stages of clinical study
Detailed Description:
Local tumor destruction with non-surgical ablation NSA cryoablation or radiofrequency induces inflammation and releases antigens that can activate tumor-specific immune responses
Pre-clinically we demonstrated that multimodal thermal therapy MTT as an integrated treatment modality of cryotherapy and radiofrequency heating can effectively activate systemic and long-lasting antitumor immunity
In this pilot study patients with operable HER2-negative breast cancer were designed to receive a combination of MTT immunotherapy and neoadjuvant chemotherapy Potential favorable intra-tumoral and systemic immunologic effects were assessed with the combination revealing the possibility for induced and synergistic anti-tumor immunity with this strategy
Pre-clinically we demonstrated that multimodal thermal therapy MTT as an integrated treatment modality of cryotherapy and radiofrequency heating can effectively activate systemic and long-lasting antitumor immunity
In this pilot study patients with operable HER2-negative breast cancer were designed to receive a combination of MTT immunotherapy and neoadjuvant chemotherapy Potential favorable intra-tumoral and systemic immunologic effects were assessed with the combination revealing the possibility for induced and synergistic anti-tumor immunity with this strategy
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