SBRT Followed by Neoadjuvant Chemoimmunotherapy of Sindilizumab Plus Docetaxel and Cisplatin for Locoregionally Advanced Squamous Carcinoma of Oral Cavity and Oropharynx

ConditionSBRT
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • SBRT+chemoimmunotherapy

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators