NCT05098119

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• 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 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.

Conditions

• Oral Cavity Squamous Cell Carcinoma
• Oral Squamous Cell Carcinoma
• Oropharyngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Sintilimab, Nab-paclitaxel, Carboplatin	Neoadjuvant Therapy
PROCEDURE	Surgical resection	Standard of care
DRUG	Sintilimab	Adjuvant Therapy

Timeline

• Start date: 2021-09-16
• Primary completion: 2024-09-16
• Completion: 2028-09-16
• First posted: 2021-10-28
• Last updated: 2024-03-26

Locations

1 site across 1 country: China