NCT05803915

Neoadjuvant Toripalimab Plus Nimotuzumab in Oral Squamous Cell Carcinoma Prior to Radical Therapy

Neoadjuvant Toripalimab Plus Nimotuzumab in Primary Limited-Stage Oral Squamous Cell Carcinoma Prior to Radical Therapy：A Single-arm, Phase Ⅱ Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the efficacy and safety of neoadjuvant Toripalimab combined with Nimotuzumab in primary limited stage oral squamous cell carcinoma prior to radical therapy.

Detailed description

The purpose of this study is to investigate the efficacy and safety of neoadjuvant PD-1 inhibitor toripalimab plus nimotuzumab in subjects with primary limited stage, oral squamous cell carcinoma prior to radical therapy. Patients would be treated with neoadjuvant toripalimab plus nimotuzumab for 2 cycles and then received radical surgery or radiotherapy based on the efficacy assessed by investigators per RECIST v1.1.

Conditions

• Oral Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Toripalimab	The participants will receive Toripalimab 240mg intravenous infusion every 3 week, and Nimotuzumab 150mg/㎡ every 2 week for 2 cycles

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-09-30
• Completion: 2026-03-10
• First posted: 2023-04-07
• Last updated: 2023-04-07

Locations

1 site across 1 country: China