NCT04164238

Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in HNSCC Patients

Phase II Trial of Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in Head and Neck Squamous Cell Carcinoma Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluate either Toripalimab or combined with chemotherapy as neoadjuvant treatment for patients with head and neck squamous cell carcinoma. Participants in arm A receive Toripalimab, in arm B receive Toripalimab plus PC (paclitaxel and carboplatin), arm C with Toripalimab plus modified TPF(paclitaxel and cisplatin and 5-fu).

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Toripalimab	Toripalimab Injection
DRUG	Paclitaxel	Paclitaxel Injection
DRUG	Carboplatin	Carboplatin Injection
DRUG	Cisplatin	Cisplatin injection
DRUG	5-fu	5-fu injection

Timeline

• Start date: 2019-11-07
• Primary completion: 2020-11-07
• Completion: 2021-11-07
• First posted: 2019-11-15
• Last updated: 2019-11-15

Locations

1 site across 1 country: China