NCT06494943

Induction IBI110 and Sintilimab with Chemotherapy in LA HNSCC

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: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the efficacy and safety of combining sintilimab and the TP regimen with/without IBI110 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 and the TP regimen (paclitaxel and cisplatin), with/without IBI110 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.

Conditions

• Head and Neck Cancer
• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Sintilimab	PD-1 inhibitor
DRUG	IBI110	LAG-3 inhibitor
DRUG	Paclitaxel	Chemotherapy
DRUG	Cis Platinum	Chemotherapy
PROCEDURE	Surgery	Definitive surgery
RADIATION	Adjuvant radiation	Adjuvant radiotherapy or chemoradiotherapy based on post-operative pathologic findings.

Timeline

• Start date: 2024-06-26
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2024-07-10
• Last updated: 2025-02-25

Locations

1 site across 1 country: China