The Efficacy and Safety of Neoadjuvant Low-dose Radiotherapy Combined With Chemoimmunotherapy in Locally Advanced HNSCC
This study tests a new treatment approach combining low-dose radiation therapy with chemotherapy and immunotherapy given before surgery for advanced head and neck cancer. The goal is to determine if this combination treatment is effective and safe in helping patients with this type of cancer.
Key Objective:This trial is testing whether combining low-dose radiation with chemotherapy and immunotherapy before surgery can improve treatment outcomes for locally advanced head and neck squamous cell carcinoma.
Who to Consider:Patients with resectable (removable by surgery) locally advanced head and neck squamous cell carcinoma who have not yet received treatment should consider enrolling in this trial.
Trial Parameters
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Brief Summary
This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of neoadjuvant low-dose radiotherapy combined with chemoimmunotherapy in resectable locally advanced head and neck squamous cell carcinoma. The eligible patients are scheduled to administered neoadjuvant low-dose radiotherapy, tislelizumab, combined with albumin-bound paclitaxel and cisplatin for two cycles. Radical resection will be performed in 3-4 weeks after two cycles of neoadjuvant therapy. The overall primary study hypothesis is that the novel neoadjuvant combination regime improves the pathological complete response (pCR) rate, with tolerable side effects.
Eligibility Criteria
Inclusion Criteria: 1. Untreated, histologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx or larynx), staging T3-4N0M0 or T1-4N1-3M0, III-IVB, according to the eighth edition of the AJCC staging system; 2. Eligible for radical surgery, as judged by surgeons. 3. Aged ≥ 18 years and ≤ 70 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 5. Life expectancy of more than 6 months. 6. At least one measurable lesion according to RECIST 1.1. 7. Adequate organ function, based on meeting all of the following criteria (no blood components and cytologic growth factors were received within 14 days prior to the test): 1. Hemoglobin ≥ 90 g/L; absolute neutrophil count ≥ 1.5 × 109/L; and platelet count ≥ 100 × 109/L; 2. Serum albumin ≥ 28 g/L; 3. Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN; 4. Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate ≥ 50 mL/min; 5. Activated partial clotting