Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-02 @ 1:41 AM
Study NCT ID:
NCT05861557
Status:
UNKNOWN
Last Update Posted:
2023-05-17
First Post:
2023-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Radiotherapy Combined With Toripalimab for Locally Advanced Head and Neck Squamous Cell Carcinoma
Sponsor:
Tianjin Medical University General Hospital
Organization:
Study Overview
Official Title:
A Prospective Phase II Trial to Evaluate the Safety and Efficacy of Neoadjuvant Radiotherapy Combined With Immunotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
NOT_YET_RECRUITING
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 is a phase II study. Twenty-three patients with locally advanced head and neck squamous cell carcinoma were planned to be enrolled to assess the efficacy and safety of neoadjuvant immunotherapy combined with radiotherapy.
Detailed Description:
After receiving one cycle of immunotherapy, the subjects underwent SBRT radiotherapy to the lesion, followed by another cycle of immunotherapy. Surgery was performed 3-6 weeks later, and subsequent radiotherapy or chemoradiotherapy was decided after surgery based on pathological examination. Immunotherapy was maintained for 6 months. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by the principal investigator, whichever occurred first.
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?: