NCT06694350

Pembrolizumab in Combination with Flutamide Treatment for Recurrence / Metastasis HNSCC

Safety and Efficacy of Pembrolizumab in Combination with Flutamide Treatment for Advanced/Recurrence / Metastasis Head and Neck Squamous Cell Carcinoma: a Single-arm Clinical Study Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Zhejiang Provincial People's Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is a single center, single arm clinical trial for newly diagnosed patients with locally advanced head and neck squamous cell carcinoma. The main purpose is to evaluate the efficacy and safety of flutamide combined with standard immunotherapy for advanced / recurrent head and neck squamous cell carcinoma. In our previous study, we found that AR can affect the occurrence and development of tumors by regulating the differentiation of cd8+t cells. We used three different castration drugs (flutamide, goserelin and abiraterone) in animal models to treat primary and tumor bearing head and neck squamous cell carcinoma mice respectively, and found that castration treatment could significantly inhibit the tumor growth of head and neck squamous cell carcinoma. In addition, in animal models, we compared the efficacy of the combination of castration therapy and low-dose cisplatin with that of the existing first-line chemotherapy drug cisplatin, and found that the combination of castration therapy and low-dose cisplatin can significantly improve the treatment effect of head and neck squamous cell carcinoma and reduce the adverse reactions brought by the drug. Therefore, we infer that flutamide combined with standard immunotherapy can fully inhibit the growth of HNSCC and improve the prognosis of HNSCC patients.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab+Flutamide	Pembrolizumab 200mg ivgtt once +Flutamide 250mg，Q8h

Timeline

• Start date: 2024-12-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-11-19
• Last updated: 2024-11-19

Regulatory

• FDA-regulated drug study