NCT05444673

A Prospective, Single-arm Clinical Study of Pabrolizumab in Combination With Cisplatin + 5-FU for the Neoadjuvant Treatment of Unresectable, Advanced Squamous Carcinoma of the Temporal Bone Single-arm Clinical Study

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Temporal bone cancer accounts for 0.2% of head and neck cancers. Advanced temporal bone cancer often involves structures such as apices, internal carotid artery canals, and dura mater, and negative margins cannot be obtained during surgery. The recurrence rate after surgery is as high as 70%, and the 2-year survival rate is only 11%. Crestor, or paprolizumab, is a monoclonal antibody to PD1 that blocks the interaction between PD1 and the dura mater. The NCCN guidelines recommend that paprolizumab be used in combination with platinum-based anti-tumor agents. The NCCN guidelines recommend pablizumab in combination with platinum and 5-FU for the first-line treatment of recurrent, unresectable head and neck squamous carcinoma, but this regimen is not recommended for the treatment of recurrent, unresectable head and neck squamous carcinoma. This study is intended to investigate the use of pablizumab in combination with platinum and 5-FU for the first-line treatment of recurrent unresectable squamous head and neck cancer. This study investigates the effectiveness of pablizumab in combination with cisplatin and 5-FU for the adjuvant treatment of recurrent, unresectable temporal bone cancer. temporal bone cancer.

Conditions

• Temporal Bone Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Paprizumab combined with cisplatin and 5-FU	Patients with advanced temporal bone cancer were treated with pabulizumab combined with cisplatin and 5-FU

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-06-01
• Completion: 2024-12-01
• First posted: 2022-07-06
• Last updated: 2022-07-06

Locations

1 site across 1 country: China