Clinical Trial

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

Study acronym: SHINE
Not Yet Recruiting Phase 3
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Record status
This record was last updated January 28, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07371897
Lead Sponsor Sun Yat-sen University
Conditions Head and Neck Squamous Cell Carcinoma HNSCC
Enrollment 154 participants
Start Date 2026-06-30
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-28