Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401005
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-04-30
Brief Title:
SBRT Chemotherapy and AK104 Neoadjuvant Therapy for Triple-negative Breast Cancer TNBC
Sponsor:
Hubei Cancer Hospital
Organization:
Hubei Cancer Hospital
Study Overview
Official Title:
A Single-arm Open Phase II Clinical Study of SBRT Chemotherapy and Cadonilimab AK104 Neoadjuvant Therapy for Triple-negative Breast Cancer TNBC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Studies have indicated that the improvement in pathological complete response pCR is significantly correlated with triple-negative breast cancerTNBCpatients overall survival OS Patients with TNBC have poor efficacy for neoadjuvant chemotherapy The combination of neoadjuvant therapy with immunotherapy and chemotherapy has been demonstrated to enhance the pCR rate of TNBC patients increasing it from 45 to approximately 60 Therefore how to further improve the pCR rate of TNBC breast cancer became the main objective of this study Stereotactic radiotherapy SBRT not only kills tumor cells directly but also kills the distant unirradiated tumor cells by promoting the cross-initiation of tumor-specific CD8 T cells a phenomenon known as the abscopal effect Our research team has recently discovered that the triple therapy model of SBRT anti-vascular targeting anti-PD-1 was safe and efficacious in lung cancer patients Cadonilimab AK104 is an PD-1CTLA-4 bispecific antibody In order to improve the pCR a single-arm open phase II clinical study was proposed to explore the safety and efficacy of SBRTAK104chemotherapy a neoadjuvant treatment modality in the treatment of TNBC
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None