NCT07079410

Neoadjuvant and Adjuvant Sintilimab Plus Cetuximab in Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma

A Single-Arm, Prospective Phase II Clinical Study on the Neoadjuvant Sintilimab Plus Cetuximab in Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness and safety of the combination therapy of immunotherapy (Sintilimab) with targeted therapy (Cetuximab) as a possible treatment before and after surgery for locally advanced oral/pharyngeal squamous cell carcinoma.

Detailed description

Approximately 60% of patients with oral/oropharyngeal squamous cell carcinoma (OSCC) are found to be in the local advanced stage. Even if they actively undergo comprehensive sequential treatment such as surgery, radiotherapy, and chemotherapy, the 5-year survival rate is still less than 50%. According to both the NCCN and the CSCO head and neck cancer treatment guidelines, radical surgery is the main treatment strategy for locally advanced OSCC, and adjuvant radiotherapy or chemotherapy/radiotherapy. However, the high treatment failure rate and disease recurrence rate are still the fundamental reasons for its poor prognosis. In recent years, neoadjuvant therapy has been proven to reduce the burden of local diseases in multiple tumor types, thereby improving surgical outcomes, reducing the risk of distant metastasis, and predicting prognosis based on the patient's pathological response. The combination of anti-PD-1/PD-L1 monoclonal antibody and EGFR monoclonal antibody has a synergistic anti-tumor effect. Multiple prospective studies have shown that the combination of cetuximab and anti-PD-1 monoclonal antibody has achieved good efficacy in the treatment of recurrent/metastatic head and neck squamous cell carcinoma. The combination of neoadjuvant immunotherapy and EGFR monoclonal antibody therapy for locally advanced OSCC is worth exploring. This prospective, open label, single arm, phase II single center interventional study aims to evaluate the efficacy and safety of the neoadjuvant and adjunvant combination therapy of Sintilimab (anti-PD-1 monoclonal antibody) and cetuximab in patients with locally advanced OSCC.

Conditions

• Oral Squamous Cell Carcinoma (OSCC)
• Oropharyngeal Squamous Cell Carcinoma
• Resectable Oral and Oropharyngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Sintilimab+Cetuximab	Neoadjuvant treatment: the participants will receive Sintilimab 200 mg (each 3-week/cycle) and Cetuximab (400 mg/m2 first time and followed 250 mg/m2, day 1, day 8, day 15) for 2 cycles. Adjuvant treatment: the participants will receive Sintilimab 200 mg (each 3-week cycle, a total of 17 cycle) for a total of one year.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-07-01
• Completion: 2029-10-01
• First posted: 2025-07-23
• Last updated: 2025-07-23

Locations

1 site across 1 country: China