A multicenter, randomized, controlled, open-label, Phase II/III clinical trial designed to evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab,with or without Bemcentinib, in postoperative head and neck squamouscell cancer patients with intermediate-risk pathological factor. The primary endpoint is the 3-year disease-freesurvival (DFS). A total of 193 patients will be enrolled in both the experimental and control groups, resulting in a total planned enrollment of 386 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
386
Nimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles.
Nimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles. Bemcentinib: 1200 mg on Day 1, every 3 weeks (Q3W) for a total of 9 cycles, initiated 3-4 weeks after completion of radiotherapy.
Intensity-modulated radiation therapy (IMRT) will be administered at a total dose of 60Gy (2 Gy per fraction, 30 fractions)
Disease-Free Survival (DFS)
From randomization until disease recurrence, metastasis, second primary cancer, or death from any cause
Time frame: 3-year
Overall Survival (OS)
From enrollment until death from any cause
Time frame: 3-year
Adverse Events (AEs)
From the first dose of nimotuzumab through 30 days after the last dose (approximately 8 weeks total).
Time frame: 30 days after the last dose (approximately 8 weeks total).
Locoregional Recurrence-Free Survival (LRRFS)
Time frame: From enrollment until first locoregional recurrence, assessed up to 3 years after last patient enrolled
Distant Metastasis-Free Survival (DMFS)
Time frame: From enrollment until first distant metastasis, assessed up to 3 years after last patient enrolled
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