Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-28 @ 2:30 AM
Study NCT ID:
NCT06249750
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Application of Near-infrared Whole Body Heat Shock Multimodal Technique in Treatment of Castration-resistant Prostate Cancer
Sponsor:
Pengyuan Liu
Organization:
Study Overview
Official Title:
Clinical Application of Near-infrared Whole Body Heat Shock Multimodal Technique in Treatment of Castration-resistant Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-01
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:
In this study, we propose to use the combination of ET-SPACE NIR irradiation whole-body thermal stimulation, ICI (Tislelizumab), and RTK inhibitor (Anlotinib) in the multimodal treatment of CRPC.
Detailed Description:
The initial efficacy and safety of the multimodal therapy will be evaluated at the animal level to fully validate the potential feasibility of the therapy. Subsequently, the efficacy of the multimodal therapy will be verified at the organoid level, and based on which a translational randomized controlled clinical trial will be conducted to evaluate the efficacy and safety of the multimodal therapy at the human level, and the patients will be followed up for a long period of time, so as to collect detailed data on improvement of the quality of life. Finally, the synergistic effect of the multimodal therapy will be analyzed at the molecular and cellular levels.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: