Phase 2 Study of Sintilimab With Reduced Chemotherapy Cycles Before Surgery in Treating Adults With Oral Cavity or Oropharyngeal Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the efficacy and safety of sintilimab combined with a reduced number of chemotherapy cycles carboplatin and nab-paclitaxel in patients with oral cavity or oropharyngeal squamous cell carcinoma who are planning surgery. This Phase II trial aims to provide important data to guide future studies of anti-PD-1 therapies and other immunotherapies for these cancers. Participants receive neoadjuvant therapy consisting of three cycles the first cycle includes sintilimab 200mg IV, carboplatin 300mgm2 IV, and nab-paclitaxel 260mgm2 IV on day 1 the second and third cycles include sintilimab 200mg IV on day 1, each cycle lasting 21 days. After surgery, high-risk patients based on pathology may receive sintilimab intravenously every three weeks for up to one year, starting once acute toxicities from post-operative chemotherapy and radiation resolve to grade 1 or less. During the study, patients undergo surgery and receive follow-up evaluations including safety monitoring for adverse events, radiographic assessments, and survival tracking for up to five years. The primary outcome is pathological tumor response at surgery. Secondary outcomes include adverse event rates, disease-free survival at two years, overall survival at five years, radiographic response at five weeks, and rate of surgery delay within eight weeks after treatment. Participants are monitored closely throughout treatment and follow-up periods.

Neoadjuvant Sintilimab Combined With Reduction of Cycles of Chemotherapy in Resectable Oral Cavity or Oropharyngeal Squamous Cell Carcinoma (OOC-002)