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NOT YET RECRUITING
NCT05993858
PHASE2

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

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

View on ClinicalTrials.gov

Summary

This is a single-center, single-arm, phase II clinical study to evaluate the efficacy and safety of PD-1 inhibitor combined with cetuximab in neoadjuvant therapy for locally advanced HNSCC.

Official title: A Single-Center, Single-Arm Exploratory Clinical Trial of Neoadjuvant PD-1 Inhibitor Combined With Cetuximab in Operable Locally Advanced Head and Neck Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2023-10-20

Completion Date

2026-12-20

Last Updated

2023-08-15

Healthy Volunteers

No

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.

Locations (1)

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

Wuhan, Hebei, China