drugset / Trial / NCT04718415

Neoadjuvant Sintilimab in Combination With Carboplatin and Nab-paclitaxel in Resectable Oral Cavity or Oropharyngeal Squamous Cell Carcinoma

NCT04718415 ↗

Phase 2 Active not recruiting 51 enrolled Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to look at the efficacy and safety of sintilimab in combination with carboplatin and nab-paclitaxel in patients with oral cavity or oropharyngeal squamous cell carcinoma who are about to undergo surgery. Monoclonal antibodies, such as sintilimab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving sintilimab, carboplatin, and nab-paclitaxel may work better in treating patients with oral cavity and oropharyngeal squamous cell carcinoma.

Timeline

Start
2021-01-23
Primary completion
2023-01-01
Completion
2027-01-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Background Carboplatin Small molecule 300 mg/m2 Intravenous
Background Paclitaxel Small molecule 260 mg/m2 Intravenous