NCT04718415

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

Phase II Trial of Sintilimab, an Anti-PD-1 Monoclonal Antibody, in Combination With Carboplatin and Nab-paclitaxel , as a Novel Neoadjuvant Pre-Surgical Therapy for Oral Cavity or Oropharyngeal Squamous Cell Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oral Squamous Cell Carcinoma
• Oropharyngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	sintilimab, paclitaxel, carboplatin	Patients receive sintilimab IV on day 1, paclitaxel IV on day 1 and carboplatin IV on day 1 . Treatment repeats every 21 days for up to 2 - 4 courses in the absence of disease progression or unacceptable toxicity.
PROCEDURE	Surgical resection	Surgical therapy will be at the discretion of the treating surgeon per standard of care.

Timeline

• Start date: 2021-01-23
• Primary completion: 2023-01-01
• Completion: 2027-01-23
• First posted: 2021-01-22
• Last updated: 2024-09-19

Locations

2 sites across 1 country: China