Nimotuzumab: nimotuzumab group nimotuzumab, 200mg/w, for 6 weeks
cis-platinum: 30mg/m2/w, for 6 weeks
IMRT combine with cisplatin concurrent chemotherapy: IMRT, 66~70Gy (2Gy/F, 35F), for 6 weeks
painkiller: three ladders pain analgesic( First step: For mild pain, non-opioid agents (excluding nonsteroidal anti-inflammatory drugs \[NSAIDs\]) combined with adjuvant analgesics are administered; Second step: For moderate pain, weak opioids combined with NSAIDs and adjuvant analgesics are prescribed;Third step: For severe pain, strong opioids combined with NSAIDs and adjuvant analgesics are used.)
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
No
Inclusion Criteria:
* Age 18-75 years, inclusive of 18 years but exclusive of 75 years.
* ECOG Performance Status (PS) score 0-2.
* Histologically or cytologically confirmed Stage III-IVb (according to the 2020 CSCO Guidelines for Diagnosis and Treatment of Head and Neck Tumors) squamous cell carcinoma of the head and neck (including oral, oropharyngeal, hypopharyngeal, and laryngeal cancers; excluding nasopharyngeal carcinoma).
* EGFR-positive expression confirmed by immunohistochemistry.
* Patients deemed ineligible for surgery (due to physical contraindications or refusal of surgery).
* At least one measurable lesion according to RECIST 1.1 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.
* Expected survival ≥3 months.
* Adequate hematologic function:
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).
* Negative urine pregnancy test for female patients of childbearing potential (excludes those with bilateral oophorectomy, hysterectomy, or postmenopausal status).
* Signed informed consent.
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 outcome measure(s)
2-year PFS rate — From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by INV per RECIST v1.1.cause,whichever occurs first.
Trial sites (1)
Facility
City
Region
Status
Baotou Cancer Hospital
Baotou
Inner Mongolia
More Biotech Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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