This is a randomized controlled, phase II clinical study designed to explore the efficacy and safety of nimotuzumab combined with immunotherapy and chemotherapy as neoadjuvant treatment for locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The primary endpoint of the study is the 2-year event-free survival (EFS) rate. Enrollment is expected to be completed within 2 years; all patients will be followed up for at least 2 years after the last patient is enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
Nimotuzumab 400mg,d3,Q3W,for two cycles。
tislelizumab (or pembrolizumab) 200mg,d1,Q3W,for two cycles。
Albumin-bound paclitaxel 180 mg/m² (or docetaxel 75 mg/m²), administered on day 3, every 3 weeks (Q3W);for two cycles。
Cisplatin 75 mg/m² (carboplatin AUC=5 may be substituted if cisplatin is not tolerated), administered on day 3, every 3 weeks (Q3W).for two cycles。
Standard radical surgery of tumor
Concurrent chemoradiotherapy: Radiotherapy: intensity modulated conformal radiotherapy (IMRT) was used with a total dose of 60-66gy (2gy/f, 30-33f). Chemotherapy: Cisplatin 40 mg/m2, QW, 6-7 times in total; Targeting: nimotuzumab 200mg, QW, 6-7 times in total.
Shanghai First People's Hospital
Shanghai, China
RECRUITING2-Year Event-Free Survival (EFS) Rate
Time frame: From first study treatment up to 2 years after the last patient randomized.
Major Pathologic Response (MPR)
Time frame: Within 4 weeks after surgery.
Pathological Complete Response (pCR)
Time frame: Within 4 weeks after surgery.
Objective Response Rate (ORR)
Time frame: After 2 cycles (each cycle is 21 days) of neoadjuvant treatment.
2-Year Overall Survival (OS) Rate
Time frame: From first study treatment up to 2 years after the last patient randomized.
Quality of Life (QoL)
Assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires QLQ-C30 (V3.0). EORTC QLQ-C30 V3.0:The scale consists of general domain items and global health and quality of life items. General domain items are further divided into functional domains and symptom domains. The raw scores of general items range from 1 (minimum) to 4 (maximum), while those of global health and quality of life items range from 1 (minimum) to 7 (maximum). All raw scores are finally standardized to scores ranging from 0 to 100. In functional domains including PF, RF, EF, CF, SF and QL, higher scores indicate better functional status. In symptom domains including FA, NV, PA, DY, SL, AP, CO, DI and FI, higher scores stand for more severe symptoms. For the global health and quality of life domain, higher scores reflect better general health condition and quality of life.
Time frame: Baseline(Screening) After neoadjuvant chemotherapy:Study Group(S)Week6 /Control Group(C)NA Post-surgery:S Week 9/C Week 3 After adjuvant radiotherapy(S Week 21/C Week 15) End of treatment(Week 24) Follow-up: Month 6, Month 12, Month 24
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