Toripalimab Maintenance After First-line Comprehensive Therapy for Locally Advanced Head and Neck Squamous Cell Carcinoma: a Single-arm, Phase II Study

• Status: Not yet recruiting
• Trial end date: 2028-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The guidelines for locally advanced head and neck squamous cell carcinoma currently recommend surgery / radiotherapy / chemotherapy / targeted therapy. However, the median PFS of patients with high risk factors after comprehensive treatment was about 17 months, and the 2-year PFS rate was about 40 %. The KEYNOTE-048 study showed that PD-1 monoclonal antibody alone or in combination with chemotherapy significantly improved survival and was safe for recurrent / metastatic head and neck squamous cell carcinoma. Therefore, PD-1 monoclonal antibody has become the first-line treatment of metastatic head and neck squamous cell carcinoma. For locally advanced head and neck squamous cell carcinoma, the existing studies on immunotherapy for neoadjuvant or concurrent chemoradiotherapy have not been clearly concluded. We previously used PD-1 monoclonal antibody for the maintenance treatment of patients after the first-line treatment of locally advanced head and neck squamous cell carcinoma, without residual tumor, which showed a trend of prolonged survival. Therefore, this study intends to explore whether the maintenance treatment of PD-1 monoclonal antibody terripril can further improve the survival of patients with locally advanced head and neck squamous cell carcinoma with high risk factors and no residual tumor after first-line comprehensive treatment, and the safety is good.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University

Criteria

Inclusion Criteria:

Non-pregnant patients > 18 years old, with ECOG performance status 0-1, adequate bone marrow, liver, and renal function, and previously untreated, histologically proven HNSCC, stage III-IVa were eligible for enrollment. All patients underwent margin-clearing surgery with real-time pathologic assessment for the primary tumor and neck dissection with curative intent. Eligible patients had one or more pathologic high-risk factor. Screening for distant metastases was performed with either chest computed tomography (CT) or positron emission tomography/CT. Presurgical evaluation was performed by an experienced surgical team and involved a detailed physical examination, neck CT with contrast, and, when questions concerning tumor invasiveness existed, head and neck magnetic resonance imaging.

Exclusion Criteria:

• Exclusion criteria included prior invasive malignancy (other than non-melanoma skin) within the past two years, another malignancy within 5 years of registration, or any symptomatic coronary disease within the prior six months. Other ineligibility criteria were: have a history of allergy to PD-1 monoclonal antibody or drug components or previous treatment with immunosuppressive drugs.