Neoadjuvant PD-1 Inhibitor Combined With Cetuximab in Operable Locally Advanced HNSCC

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

October 20, 2023

Primary Completion Date

December 20, 2025

Study Completion Date

December 20, 2026

Conditions
Head and Neck Squamous Cell CarcinomaNeoadjuvant Therapy
Interventions
DRUG

3cycles (Toripalimab + cetuximab)

"Toripalimab by intravenous (IV) infusion every 3 weeks (Q3W), 3 preoperative and 17 consolidated doses.~The preoperative starting dose of cetuximab is 400 mg/m\^2 by IV infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m\^2 IV infusion over 60 minutes, from week 2 to 9."

PROCEDURE

Surgery

After neoadjuvant therapy, patients would accept surgery within 11-13 weeks.

RADIATION

Radiotherapy or chemoradiotherapy

Adjuvant radiotherapy was given 4 weeks after surgery. Patients with positive intraoperative pathological margins/extra lymph node envelope invasion are treated with an additional cisplatin synchronous chemotherapy.

Trial Locations (1)

430000

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

All Listed Sponsors
lead

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

NCT05993858 - Neoadjuvant PD-1 Inhibitor Combined With Cetuximab in Operable Locally Advanced HNSCC | Biotech Hunter | Biotech Hunter