NCT07371611

Sintilimab Plus Chemotherapy as Neoadjuvant and Adjuvant Treatment for Locally Advanced Oral Squamous Cell Carcinoma

Sintilimab Plus Chemotherapy as Neoadjuvant and Adjuvant Treatment for Locally Advanced Oral Squamous Cell Carcinoma: A Multicenter, Open-label, Randomized, Phase III Clinical Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Qunxing Li,MD · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, randomized phase III clinical trial evaluating perioperative treatment with sintilimab combined with chemotherapy in patients with locally advanced oral squamous cell carcinoma. Despite standard treatment with surgery followed by postoperative radiotherapy or chemoradiotherapy, patients with locally advanced oral squamous cell carcinoma remain at high risk of recurrence or metastasis. Recent evidence, including results from the KEYNOTE-689 study, suggests that perioperative immunotherapy may improve survival outcomes, and this approach has been incorporated into NCCN guidelines. Combining immunotherapy with chemotherapy may further improve prognosis in this patient population. Eligible participants will be randomly assigned to either an experimental group or a control group. The experimental group will receive neoadjuvant sintilimab combined with chemotherapy followed by surgery and postoperative treatment based on pathological response. Patients with major pathological response (MPR) will receive adjuvant sintilimab, while patients without MPR will receive postoperative radiotherapy or concurrent chemoradiotherapy combined with sintilimab. The control group will receive standard treatment consisting of surgery followed by postoperative radiotherapy or chemoradiotherapy as clinically indicated. The primary objective of the study is to compare event-free survival between the two groups. Secondary objectives include overall survival, pathological response, safety, and treatment-related adverse events. The results of this study may help optimize perioperative treatment strategies and improve outcomes for patients with locally advanced oral squamous cell carcinoma.

Detailed description

Oral squamous cell carcinoma (OSCC) is one of the most common malignancies of the head and neck region. A substantial proportion of patients present with locally advanced disease at diagnosis and remain at high risk of recurrence or metastasis despite radical surgery followed by postoperative radiotherapy or concurrent chemoradiotherapy. Previous studies have shown that conventional neoadjuvant or adjuvant chemotherapy provides limited benefit in improving long-term survival outcomes. Recent advances in immunotherapy have demonstrated significant efficacy in recurrent or metastatic head and neck squamous cell carcinoma, and emerging evidence supports the role of perioperative immunotherapy in resectable disease. The KEYNOTE-689 study demonstrated that perioperative immunotherapy could improve event-free survival in patients with locally advanced, resectable head and neck squamous cell carcinoma, leading to the incorporation of this strategy into the National Comprehensive Cancer Network (NCCN) guidelines. However, further optimization of perioperative treatment strategies is required to enhance pathological response and survival outcomes, particularly in patients with locally advanced OSCC. This study is a multicenter, open-label, randomized phase III clinical trial designed to evaluate the efficacy and safety of perioperative sintilimab combined with chemotherapy compared with standard treatment (surgery with or without postoperative radiotherapy or chemoradiotherapy) in patients with locally advanced OSCC. Eligible patients will be randomized in a 1:1 ratio to either the experimental group or the control group. Patients in the experimental group will receive neoadjuvant sintilimab combined with chemotherapy prior to definitive surgical resection. Postoperative treatment will be stratified according to pathological response. Patients achieving major pathological response (MPR) will receive adjuvant sintilimab for at least six cycles or until unacceptable toxicity. Patients without MPR will receive postoperative radiotherapy or concurrent chemoradiotherapy sequentially combined with sintilimab for at least six cycles or until unacceptable toxicity. Patients in the control group will receive standard treatment consisting of surgical resection followed by postoperative radiotherapy or concurrent chemoradiotherapy as clinically indicated. The primary endpoint of the study is event-free survival. Secondary endpoints include overall survival, pathological response to treatment, safety, and treatment-related adverse events. This study is expected to provide high-level evidence to optimize perioperative treatment strategies and improve clinical outcomes for patients with locally advanced oral squamous cell carcinoma.

Conditions

• Locally Advanced Oral Squamous Cell Carcinoma
• Oral Squamous Cell Carcinoma (OSCC)

Interventions

Type	Name	Description
DRUG	Sintilimab plus nab-paclitaxel and platinum-based chemotherapy	Neoadjuvant sintilimab combined with TP regimen followed by radical surgery and risk-stratified adjuvant therapy (low-risk: sintilimab monotherapy; high-risk: radiotherapy or concurrent chemoradiotherapy followed by sequential sintilimab).
PROCEDURE	Radical surgery combined with radiotherapy or chemoradiotherapy	Participants undergo radical surgical resection as primary treatment, followed by postoperative radiotherapy or concurrent chemoradiotherapy according to pathological risk factors and standard clinical practice.

Timeline

• Start date: 2026-01-01
• Primary completion: 2030-12-31
• Completion: 2033-12-31
• First posted: 2026-01-28
• Last updated: 2026-01-28

Locations

1 site across 1 country: China