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The purpose of this study is to investigate the impact of combining Nimotuzumab with analgesic agents on pain management outcomes, as well as the effectiveness and safety profile of this therapeutic combination in the comprehensive treatment of locally advanced head and neck squamous cell carcinoma.
Full description
The study is an open-label, randomized controlled phase II clinical trial designed to evaluate the impact of Nimotuzumab combined with analgesic therapy on pain management outcomes, as well as the therapeutic efficacy and safety profile of this combination in the comprehensive treatment of locally advanced head and neck squamous cell carcinoma.
Eligible participants will be randomly assigned to either the experimental group or the control group. Patients in the experimental group will receive Nimotuzumab plus analgesic therapy in addition to concurrent radiochemotherapy, while those in the control group will undergo analgesic therapy combined with concurrent radiochemotherapy alone.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:
CT scan ≥10 mm (tumors not measurable by calipers should be recorded as non-measurable).
Chest X-ray ≥20 mm. Pathologically enlarged lymph nodes: short-axis ≥15 mm on CT scan (slice thickness ≤5 mm).
Suitable for comprehensive treatment with curative or palliative intent. ●Baseline pain assessment: Numeric Rating Scale (NRS) score ≥1. Patients not previously treated with opioids who are candidates for opioid therapy.
Patients on weak opioids with inadequate pain control requiring escalation to strong opioids.
Patients with moderate-to-severe cancer pain on strong opioids with inadequate control.
Patients requiring urgent intervention due to poorly controlled pain.
White blood cell count ≥4×10^9/L. Absolute neutrophil count ≥1.5×10^9/L. Platelets ≥100×10^9/L. Hemoglobin ≥90 g/L.
●Adequate renal function: Serum creatinine ≤1.2 mg/dL or creatinine clearance ≥60 mL/min.
●Adequate hepatic function: Total bilirubin ≤1.5×ULN (≤3.0×ULN if liver metastases present). AST and ALT ≤2.5×ULN (≤5.0×ULN if liver metastases present).
Exclusion Criteria
Received radiotherapy, chemotherapy, monoclonal antibody therapy, oral EGFR-TKI therapy, anti-angiogenic agents, or immunosuppressants within the past 6 months.
Participation in another interventional clinical trial within 30 days prior to screening.
Presence of distant metastases.
History of other malignancies (except cured cervical carcinoma in situ, basal cell carcinoma of the skin, or malignancies cured ≥5 years prior).
Uncontrolled comorbidities (e.g., heart failure, diabetes, hypertension, thyroid disorders, psychiatric diseases).
Active HIV infection, viral hepatitis, or severe active infections (>Grade 2 per CTCAE v5.0).
Chronic steroid therapy (>10 mg/day prednisone equivalent for >6 months).
Known hypersensitivity to any component of the study drugs.
●≥Grade 2 peripheral neuropathy or hearing loss (per NCI CTCAE v5.0).
Pregnancy, lactation, or refusal to use effective contraception (for both male and female participants) until 6 months after the last treatment.
Investigator judgment of unsuitability for the study.
Unwillingness or inability to provide informed consent.
Primary purpose
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171 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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