Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444009
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-30
Brief Title:
A Phase II Study of Neoadjuvant Immunotherapy in Combination With Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
Sponsor:
Lei Liu
Organization:
West China Hospital
Study Overview
Official Title:
Neoadjuvant Immunotherapy in Combination With Chemotherapy in Resectable Head and Neck CancerA Randomized Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
A Randomized Phase II Study of ivonescimab or cadonilimab or penpulimab in Combination With Cisplatin and Nab-paclitaxel in Patients With III-IVB according to the 8th edition of UICCAJCC staging locally advanced head and neck squamous cell carcinoma HNSCC eligible for resection This proposed study will evaluate the efficacy and safety of preoperative administration of ivonescimab or cadonilimab or penpulimab combined with chemotherapy in HNSCC who are eligible for resection
Detailed Description:
In this study eligible patients will be randomized in a 111 ratio to either the ivonescimab combined with chemotherapy treatment group Cohort 1 or the cadonilimab combined with chemotherapy treatment group Cohort 2 or the penpulimab combined with chemotherapy treatment group Cohort 3 Pathological response rate will be the primary outcome measures Adverse events will also be recorded
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?:
False
Is an FDA AA801 Violation?:
None