Neoadjuvant and Adjuvant Toripalimab and Cetuximab in Patients With Recurrent, Resectable Squamous Cell Carcinoma of Head and Neck: a Prospective, Single-arm,Phase II Study

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

October 13, 2022

Primary Completion Date

April 28, 2025

Study Completion Date

April 28, 2026

Conditions
Patients With Locally Recurrent Resectable Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

Toripalimab+cetuximab

"Toripalimab administered by intravenous drip at a fixed dose of 240 mg for subjects weighing \<50 kg at baseline, using 3 mg/kg. administered every 3 weeks, 2 preoperative and 6 postoperative doses.~The starting dose of cetuximab is 400 mg/m2, with a titration time of 120 min, and the titration rate should be controlled within 5 ml/min. The maintenance dose is 250 mg/m2 administered weekly for a total of 6 preoperative doses; patients with positive intraoperative pathological margins/extra lymph node envelope invasion are treated with an additional 6 cycles of postoperative cetuximab adjuvant therapy."

Trial Locations (1)

200011

the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

All Listed Sponsors
lead

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER