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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
240mg, Q3W,I.V., D1, 2 cycles (1cycle of toripalimab before and after the SBRT radiotherapy, respectively), followed by the maintenance of toripalimab for 6 months after the surgery.
Subjects were treated with SBRT radiotherapy (8Gy\*5Fx), after 1 cycle of immunotherapy
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Tianjin Medical University General Hospital
Tianjin, China
Major pathological response (MPR)
Percentage of Participants with MPR. MPR is defined as \> 90 percent decrease in viable tumor.
Time frame: up to 6 months
Pathological Complete Response (pCR)
Percentage of Participants with pCR. pCR is defined as the absence of residual tumor in both primary tumor and lymph nodes after neoadjuvant treatment.
Time frame: up to 6 months
Frequency and severity of perioperative adverse events
Grade 2-5 AEs according to NCI-CTCAE V5.0
Time frame: up to 6 months
Quality of life questionnaires
EORTC Core Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: up to 1 year
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