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.
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;
Eligible for radical surgery, as judged by surgeons.
Aged ≥ 18 years and ≤ 70 years.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Pregnant or lactating women.
A history of allergies to PD-1 inhibitors or any of albumin-bound paclitaxel or cisplatin.
A history of other malignant tumors within the previous 5 years or at the time of enrollment, except for cured skin basal cell carcinoma and cervical in situ cancer, as well as thyroid papilloma.
Uncontrolled cardiac clinical symptoms or diseases, such as :(1) NYHA class II or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, and (4) patients with clinically significant ventricular or ventricular arrhythmias requiring intervention.
Single group
Tislelizumab
DrugTislelizumab: 200 mg D1, Q3W for two cycles. Albumin-bound paclitaxel: 100mg/m2, D1, D8, D15, Q3W for two cycles. Cisplatin: 25mg/m2, D1, D8, D15, Q3W for two cycles.
Low-dose radiotherapy
RadiationLow-dose radiotherapy: 1GY/1F, D1, D2, D8, D15, Q3W for two cycles. The total radiation dose will be GTV 8Gy/8F, GTVnd 8 Gy/8F.
Pathological complete response (pCR) rate
the proportion of patients with no residual viable tumor cell under microscope
Major pathological response (MPR) rate
the proportion of patients with the percentage of residual viable tumor cells in the tumor bed less than 10%
Objective Response Rate (ORR)
the proportion of patients with radiographic objective responses (complete response and partial response)
Incidence of treatment-related adverse events
CTCAE 5.0
Non-surgery-delay rate
the proportion of patients with surgical operation conducted more than four weeks longer than scheduled
Progression-free survival (PFS)
3-year progression free survival rate
Overall survival (OS)
3-year overall survival rate
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Fifth Affiliated Hospital, Sun Yat-Sen University
Lead sponsor
Dongguan People's Hospital
Collaborator
