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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

NCT05586100 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-07-31

No results posted yet for this study

Summary

This study is the first clinical study of Neoadjuvant and Adjuvant treatment of head and neck squamous cell carcinoma with drugs targeting EGFR signaling pathway combined with PD-1 inhibitors, which explores the new combination therapies urgently needed in clinical practice and lays a foundation for subsequent studies, with important scientific research significance and clinical value.

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Yue He, M.D. · the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-13
Primary Completion
2025-04-28
Completion
2026-04-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05586100 on ClinicalTrials.gov