Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-27 @ 3:10 AM
Study NCT ID:
NCT06952868
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Boron Neutron Capture Therapy With B10 L-BPA for Unresectable Recurrent Head and Neck Cancers
Sponsor:
China Medical University Hospital
Organization:
Study Overview
Official Title:
A Phase II Study to Evaluate the Efficacy and Safety of the Boron Neutron Capture Therapy (BNCT) Using the B10 L-BPA as Boron Carrier in Patients With Unresectable Recurrent Head and Neck Cancers
Status:
RECRUITING
Status Verified Date:
2025-06
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:
This Phase II study, titled "A Phase II Study to Evaluate the Efficacy and Safety of Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Patients with Unresectable Recurrent Head and Neck Cancers," aims to assess the efficacy and safety of B10 L-BPA-based BNCT in this patient population. The primary objective is to evaluate its efficacy, while secondary objectives include assessing safety, survival outcomes, tumor response, and the pharmacokinetics (PK) profile of B10 L-BPA and boron.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: