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RECRUITING
NCT05446467
PHASE2

Pembrolizumab in Combination With Low-dose PFas Neoadjuvant Treatment for Locally Advanced HNSCC

Sponsor: Zhejiang Provincial People's Hospital

View on ClinicalTrials.gov

Summary

A phase Ⅱ open label multi-cencter clinical trail to evaluate the efficacy and safety of pembrolizumab combined with low-dose PF (cisplatin + 5-fluorouracil) in the neoadjuvant treatment of locally advanced head and neck squamous cell carcinoma

Official title: Safety and Efficacy of Pembrolizumab in Combination With Low-dose PF (Cisplatin and 5-Fluorouracil) as Neoadjuvant Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma: a Multi-center, Single-arm Clinical Study Trial

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2022-09-01

Completion Date

2026-06-01

Last Updated

2025-08-20

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

pembrolizumab+cisplatin + 5-FU

ivgtt, pembrolizumab 200mg d1+cisplatin20 mg/m2 qd d1-d3 + 5-fluorouracil 3000mg/m2 last for 120hours, six circles. Subjects will undergo surgery after receiving neoadjuvant chemotherapy within 3 weeks, followed by adjuvant therapy and pembrolizumab alone maintenance treatment.

Locations (7)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital School of Medicine,Zhejiang University

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Ningbo Medical Center Lihuili Hospital

Ningbo, China

Tianjin Cancer Hospital Airport Hospital

Tianjin, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China