drugset / Trial / NCT07371897

Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial

NCT07371897

Phase 3 Not yet recruiting 154 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

This study compares two short pre-surgery treatments for locally advanced head and neck squamous cell cancer to see which one keeps the cancer from coming back longer. Eligible patients (18-70 years, newly diagnosed, operable) will be randomly assigned to receive either toripalimab (immunotherapy) alone or toripalimab plus two cycles of chemotherapy (docetaxel and cisplatin). After the two cycles, all patients will have standard surgery followed by radiation (or chemo-radiation). We will track tumor response, side effects, and quality of life. Possible benefits: tumor shrinkage and lower chance of recurrence; possible risks: low blood counts, rash, tiredness, or other drug-related side effects. Taking part is voluntary and you can leave the study at any time.

Timeline

Start
2026-06-30
Primary completion
2026-06-30
Completion
2026-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Toripalimab Monoclonal antibody 240 mg Intravenous