In resectable locally advanced oral cavity cancer and oropharyngeal cancer, SBRT with the total dose of 18 Gy by three fractions will be delivered to the primary tumor and metastatic lymph nodes every other day. One week later, neoadjuvant chemoimmunotherapy of Sindilizumab (200mg) plus docetaxel (75mg/m2) and cisplatin (75mg/m2) will be administered every three weeks for three cycles. Then radical surgical resection will be performed and postoperative radiotherapy with or without chemotherapy will be supplemented according to the initial tumor staging and postoperative pathologic characteristics. The investigators aim to evaluate the pathological complete response rate and safety of the combined treatment of SBRT with chemoimmunotherapy in locally advanced cancers of oral cavity and oropharynx.
pathologically confirmed squamous carcinoma of oral cavity or oropharynx
III-IVa based on the eighth edition of AJCC
aged 18 to 70
ECOG PS 0-1
diagnosed with other malignant tumors
has autoimmune diseases or serious mental illness
at high risk of hemorrhage
Systemic or local glucocorticoid therapy within 4 weeks
Single group
SBRT+chemoimmunotherapy
Combination productAll eligible patients will receive SBRT (6Gy\*3 fractions, qod) to the primary site and metastatic lymph nodes. One week later, neoadjuvant chemoimmunotherapy of Sindilizumab (200mg) plus docetaxel (75mg/m2) and cisplatin (75mg/m2) will be administered every three weeks for three cycles. Then radical surgical resection will be performed and postoperative radiotherapy with or without chemotherapy will be supplemented according to the initial tumor staging and postoperative pathologic characteristics.
rate of pathological complete response
pathological complete response rate after radical resection
rate of major pathological response
objective response rate
disease free survival
overall survival
Click on the lead sponsor to view all of their trials.
