About this trial
The purpose of this randomized Phase II study is to evaluate and compare the efficacy and safety of neoadjuvant radio-immunotherapy versus immunotherapy alone for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). Participants will be randomly assigned to one of two groups. The experimental group will receive a combination of radiotherapy and Adebrelimab as neoadjuvant treatment, while the control group will receive Adebrelimab monotherapy. Following the neoadjuvant phase, all eligible patients will undergo surgical resection. The primary objective is to determine if the addition of radiotherapy improves the major pathological response (MPR) rate. Secondary objectives include pathological complete response (pCR) rate, objective response rate (ORR), and event-free survival (EFS).
Eligibility criteria
Qualifiers
Histologically confirmed, treatment-naive, resectable head and neck squamous cell carcinoma (HNSCC).
Clinical stage III to IVB (according to AJCC 8th edition), excluding HPV-positive oropharyngeal cancer.
PD-L1 expression with a Combined Positive Score (CPS) ≥ 1.
Karnofsky Performance Status (KPS) score ≥ 70.
Disqualifiers
Prior radical surgery, radiotherapy, or immunotherapy for head and neck malignancies.
Severe comorbidities that may interfere with study participation, such as uncontrolled cardiovascular disease or active infections.
Active Hepatitis B virus (HBV) infection (HBsAg positive and HBV DNA ≥ 500 IU/mL).
Pregnant or breastfeeding women.
Trial design
Treatments tested in this trial
- Adebrelimab
- radiotherapy
Treatment groups
Sponsors and collaborators
Chen Chunyan
Lead sponsor
Sun Yat-sen University
Sponsor institution
Shanghai Shengdi Pharmaceutical Co., Ltd
Collaborator