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A Single-center Phase II Study to Investigate the Immune Maintenance Therapy Pattern in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Who Have Achieved MPR After Neoadjuvant Immunotherapy Combined With Chemotherapy
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Summary
Head and neck cancer is the malignant tumor with the highest morbidity and mortality, of which 60% present with locally advanced disease at initial diagnosis, and the 5-year survival rate of standard treatment is less than 30%. Standard of care (SOC) including adjuvant and neoadjuvant therapy can provides only about 5-10% clinical benefit. According to the available data on the application of immunotherapy as adjuvant therapy in operable patients, adjuvant immunotherapy is safe and feasible, with a significant trend of benefit. Based on the above positive and meaningful clinical needs and scientific basis, it is very necessary to carry out clinical trials of adjuvant immunotherapy. The primary objective of this study is to evaluate the efficacy and safety of immune maintenance therapy in patients with locally advanced head and neck squamous cell carcinoma who achieve MPR after neoadjuvant immunotherapy combined with chemotherapy.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
268
Start Date
2023-09-01
Completion Date
2029-09-01
Last Updated
2026-03-03
Healthy Volunteers
No
Conditions
Interventions
Toripalimab
Toripamab, IV, 240mg, every 3 weeks for 15 cycles
Radiation Therapy
Radiation Therapy
Cisplatin
Chemotherapy agent
Locations (1)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China