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Brief Title: Neoadjuvant Radiotherapy Combined With Toripalimab for Locally Advanced Head and Neck Squamous Cell Carcinoma
Official Title: A Prospective Phase II Trial to Evaluate the Safety and Efficacy of Neoadjuvant Radiotherapy Combined With Immunotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
Study ID: NCT05861557
Brief Summary: This is a phase II study. Twenty-three patients with locally advanced head and neck squamous cell carcinoma were planned to be enrolled to assess the efficacy and safety of neoadjuvant immunotherapy combined with radiotherapy.
Detailed Description: After receiving one cycle of immunotherapy, the subjects underwent SBRT radiotherapy to the lesion, followed by another cycle of immunotherapy. Surgery was performed 3-6 weeks later, and subsequent radiotherapy or chemoradiotherapy was decided after surgery based on pathological examination. Immunotherapy was maintained for 6 months. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by the principal investigator, whichever occurred first.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Tianjin Medical University Cancer Institute and Hospital, Tianjin, , China
Tianjin Medical University General Hospital, Tianjin, , China
Name: Huifang Zhou
Affiliation: Tianjin Medical University General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Ximei Zhang
Affiliation: Tianjin Medical University Cancer Institute and Hospital
Role: PRINCIPAL_INVESTIGATOR