drugset / Trial / NCT05098119

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

NCT05098119 ↗

NaSingle-groupOpen-labelTreatment

Summary

The study is being conducted to evaluate the efficacy and safety of sintilimab in combination with reduction of cycles of chemotherapy (carboplatin and nab-paclitaxel) in patients with oral cavity or oropharyngeal squamous cell carcinoma who are about to undergo surgery. Data obtained in this trial will provide valuable information for planning further prospective clinical trials of anti-PD-1 and other immunotherapies in oral cavity or oropharyngeal squamous cell carcinoma.

Timeline

Start
2021-09-16
Primary completion
2024-09-16
Completion
2028-09-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 300 mg/m2 Intravenous
Subject Nab-paclitaxel Small molecule 260 mg/m2 Intravenous
Subject Sintilimab Monoclonal antibody 200 mg Intravenous