Ignite Creation Date:
2024-07-17 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494943
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-03
Brief Title:
Induction IBI110 and Sintilimab With Chemotherapy In LA HNSCC
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Neoadjuvant IBI110 and Sintilimab In Combination With Chemotherapy In Resectable Locally Advanced Head And Neck Squamous Cell Carcinoma HNSCC- a Phase Ib Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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 study aims to investigate the efficacy and safety of combining IBI110 and sintilimab with the TP regimen for neoadjuvant chemotherapy in resectable locally advanced head and neck squamous cell carcinoma HNSCC
Detailed Description:
The NCCN guidelines recommend that for resectable locally advanced HNSCC the recommended treatment include surgery combined with postoperative adjuvant radiotherapy chemoradiotherapy or concurrent chemoradiotherapy for locally extensive HNSCC the guidelines recommend considering neoadjuvant chemotherapy with subsequent selection of surgery or chemoradiotherapy based on the efficacy of the neoadjuvant chemotherapy In recent years multiple studies have shown that combining PD-1 inhibitors with neoadjuvant chemotherapy may help improve the pathological response rate of surgical resection
LAG-3 Lymphocyte Activation Gene 3 is a cell surface molecule co-expressed with CD4 and CD8 on activated CD4 and CD8 T cells natural killer NK cells B cells and dendritic cells LAG-3 is an activation-induced T cell receptor TCR co-receptor with high affinity for major histocompatibility complex MHC class II molecules and it can directly inhibit TCR signal transduction in the immune response through its interaction with MHC II
IBI110 can directly bind to LAG-3 on T cells blocking the interaction between LAG-3 and MHC II thereby relieving the inhibitory effect of LAG-3 on T cell activation and enhancing the anti-tumor immune response of T cells Additionally LAG-3 and PD-1 are both immune checkpoint receptors Co-inhibition of LAG-3 and PD-1 can enhance immune responses and inhibit tumor growth Therefore IBI110 and its combination therapy with PD-1 monoclonal antibodies have great development potential in the treatment of locally advanced recurrent and late-stage solid tumors
Based on the aforementioned foundation this study intends to enroll patients with resectable locally advanced head and neck squamous cell carcinoma HNSCC The treatment protocol will involve neoadjuvant therapy with IBI110 and sintilimab combined with the TP regimen docetaxel and cisplatin for neoadjuvant chemotherapy Following neoadjuvant therapy patients will undergo radical surgery and adjuvant radiotherapy chemoradiotherapy will be administered postoperatively based on pathological risk factors as appropriate The primary endpoints of the study are efficacy and safety
LAG-3 Lymphocyte Activation Gene 3 is a cell surface molecule co-expressed with CD4 and CD8 on activated CD4 and CD8 T cells natural killer NK cells B cells and dendritic cells LAG-3 is an activation-induced T cell receptor TCR co-receptor with high affinity for major histocompatibility complex MHC class II molecules and it can directly inhibit TCR signal transduction in the immune response through its interaction with MHC II
IBI110 can directly bind to LAG-3 on T cells blocking the interaction between LAG-3 and MHC II thereby relieving the inhibitory effect of LAG-3 on T cell activation and enhancing the anti-tumor immune response of T cells Additionally LAG-3 and PD-1 are both immune checkpoint receptors Co-inhibition of LAG-3 and PD-1 can enhance immune responses and inhibit tumor growth Therefore IBI110 and its combination therapy with PD-1 monoclonal antibodies have great development potential in the treatment of locally advanced recurrent and late-stage solid tumors
Based on the aforementioned foundation this study intends to enroll patients with resectable locally advanced head and neck squamous cell carcinoma HNSCC The treatment protocol will involve neoadjuvant therapy with IBI110 and sintilimab combined with the TP regimen docetaxel and cisplatin for neoadjuvant chemotherapy Following neoadjuvant therapy patients will undergo radical surgery and adjuvant radiotherapy chemoradiotherapy will be administered postoperatively based on pathological risk factors as appropriate The primary endpoints of the study are efficacy and safety
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