A Multicenter, Randomized, Controlled, Open-Label, Phase III Clinical Trial.To evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab followed by Benmelstobart in high-risk patients with head and neck squamous cell carcinoma who are ineligible for cisplatin chemotherapy. The primary endpoint is disease-free survival (DFS). A total of 185 patients will be enrolled in both the study group and the control group, respectively, with a total planned enrollment of 370 patients. Enrollment is expected to be completed within 2 years, followed by a 3-year follow-up period after the last patient is enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
370
1200 mg on Day 1, every 3 weeks (Q3W) for a total of 17 cycles, initiated 3-4 weeks after completion of radiotherapy.
200 mg on Day 1, once weekly (QW) for a total of 7 cycles.
Intensity-modulated radiation therapy (IMRT) will be administered at a total dose of 60-66 Gy (2 Gy per fraction, 30-33 fractions). A boost to a clearly defined high-risk area may be applied at the investigator's discretion.
Shanghai 9th people's hospital
Shanghai, China
RECRUITINGDisease-Free Survival (DFS
Time frame: From enrollment until disease recurrence, metastasis, second primary cancer, or death from any cause, assessed up to 3 years after last patient enrolled
Overall Survival (OS)
Time frame: From enrollment until death from any cause, assessed up to 3 years after last patient enrolled
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
Change From Baseline in Global Quality of Life Score (EORTC QLQ-C30)
Assessed using EORTC QLQ-C30 (V3) questionnaires.The EORTC QLQ-C30 is a 30-item validated questionnaire designed to assess the quality of life in cancer patients. It includes five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea/vomiting), a global health status/quality of life scale, and six single items assessing additional symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All scales and single items are scored on a range from 0 to 100. For the functional scales and global health status scale, higher scores indicate better quality of life or functioning. For the symptom scales and single items, higher scores indicate worse symptoms or greater severity.
Time frame: Up to 24 months.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Incidence of Treatment-Emergent Adverse Events (CTCAE 5.0)
Time frame: From the first dose of nimotuzumab through 30 days after the last dose (approximately 8 weeks total).]
Change From Baseline in Head and Neck-Specific Quality of Life Score (EORTC QLQ-H&N35)
Assessed using EORTC QLQ-H\&N35 questionnaires.The EORTC QLQ-H\&N35 is a 35-item validated questionnaire specifically designed to assess quality of life in head and neck cancer patients. It includes seven symptom scales (pain, swallowing, senses, speech, social eating, social contact, and sexuality) and eleven single items addressing additional head and neck-specific symptoms (e.g., teeth problems, mouth opening, dry mouth, sticky saliva, coughing, feeling ill, use of painkillers, nutritional supplements, feeding tube, weight loss, and weight gain). All scales and single items are scored on a range from 0 to 100, with higher scores indicating worse symptoms or greater severity.
Time frame: Up to 24 months
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