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).
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.
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.
Parallel
Adebrelimab
DrugA humanized IgG4 monoclonal antibody against programmed cell death-ligand 1 (PD-L1). Dosage: 1200 mg administered via intravenous (IV) infusion on Day 1 of each 21-day cycle, for a total of 2 cycles in the neoadjuvant setting.
radiotherapy
RadiationNeoadjuvant radiotherapy targeting the primary tumor and involved cervical lymph nodes. (SBRT with a total dose of \[24\] Gy in \[3\] fractions).
Major Pathological Response (MPR) Rate
The percentage of participants with 10% or less residual viable tumor cells in the resected primary tumor and lymph nodes following neoadjuvant therapy. Assessment will be performed by independent pathologists.
Pathological Complete Response (pCR) Rate
The percentage of participants with no residual viable tumor cells (0%) in the resected primary tumor and lymph nodes.
Objective Response Rate (ORR)
The percentage of participants with a complete response (CR) or partial response (PR) based on RECIST v1.1 criteria as assessed by imaging (CT or MRI) prior to surgery.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Percentage of participants with treatment-emergent adverse events (TEAEs) as defined by CTCAE v5.0. Adverse events include immune-related adverse events (irAEs) and radiation-related toxicities. Severity will be graded for each event according to CTCAE v5.0 criteria.
Changes in Tumor Microenvironment (TME) Immune Cell Populations
Changes in the density of immune cell populations (including CD8+ T cells and M1/M2 macrophages) and PD-L1 expression in the tumor microenvironment. Each parameter will be reported as a percentage of total nucleated cells, comparing baseline biopsy specimens to surgical specimens.
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Chen Chunyan
Lead sponsor
Sun Yat-sen University
Sponsor institution
Shanghai Shengdi Pharmaceutical Co., Ltd
Collaborator
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