NCT05517330

Neoadjuvant Tislelizumab With Afatinib for Resectable Head and Neck Squamous Cell Carcinoma

Neoadjuvant Tislelizumab With Afatinib for the Treatment of Resectable Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase 2 Trial (neoCHANCE-1 Trial)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the efficiency and safety of anti-Programmed death-1 (PD-1) immunotherapy, tislelizumab, combined with EGFR-tyrosine kinase inhibitor (TKI), afatinib as a new neoadjuvant treatment regimen for patients with resectable head and neck squamous cell carcinoma (HNSCC).

Detailed description

Head and neck squamous cell carcinoma (HNSCC) is the most common malignancy of the head and neck. More than 60% of patients with HNSCC have locally advanced or metastatic disease at the time of diagnosis, with a 5-year overall survival rate of less than 60%. The clinical outcomes of those patients still need to be improved. Neoadjuvant therapy theoretically can reduce tumor volume, increase organ retention rate, and reduce distant metastasis rate. However, in addition to nasopharyngeal carcinoma, results from several phase III clinical trials have not proved a significant survival benefit of neoadjuvant chemotherapy for patients with resectable HNSCC. It is urgent to explore new neoadjuvant treatment options to improve the prognosis of patients with HNSCC. Immunotherapy such as PD-1/PD-L1 inhibitors have shown excellent efficiency in the treatment of malignancies. Anti-PD-1 therapy is approved as the first-line treatment of recurrent/metastatic HNSCC. Neoadjuvant immunotherapy for the treatment of locally advanced and resectable HNSCC has been demonstrated to be feasible in some trials. Afatinib, as an irreversible ErbB tyrosine kinase inhibitor (TKI), has been used as the second-line treatment for recurrent and/or metastatic HNSCC. However, there is a lack of high-level evidence-based medical evidence for the use of afatinib in preoperative therapy for HNSCC. A previous study published in 2018 confirmed that afatinib can be administered safely before surgery. In summary, the investigators designed this study to explore the efficiency and safety of anti-PD1 immunotherapy, tislelizumab, combined with EGFR-TKI, afatinib as a new neoadjuvant treatment regimen for patients with resectable HNSCC, aiming to provide a new treatment option for those patients.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Tislelizumab	200mg IV Q3W
DRUG	Afatinib	30mg PO QD

Timeline

• Start date: 2022-09-19
• Primary completion: 2023-12-31
• Completion: 2024-07-31
• First posted: 2022-08-26
• Last updated: 2025-07-31

Locations

1 site across 1 country: China