A Trial of Nimotuzumab and Pinkiller Efficacy and Pain in Advanced Head and Neck Squamous Cell Carcinoma

NCT06879691 | Active Not Recruiting Phase 4

• 1 other identifier: IST-Nimo-N&C-2021-03
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 2-year PFS rate

  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.

  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

Secondary Outcomes (2)

• NRS score

  Baseline, during concurrent radiochemotherapy (weeks 1,6), post-intervention (week 7), every 3 months for first 2 years, then every 6 months thereafter (through study completion, average 4 years).

• OS

  From randomization to death from any cause (up to approximately 36 months)

Study Arms (2)

nimotuzumab group

EXPERIMENTAL

nimotuzumab, 200mg/w, for 6 weeks cis-platinum, 30mg/m2/w, for 6 weeks IMRT, 66～70Gy (2Gy/F, 35F), for 6 weeks painkiller, three ladders pain analgesic

Drug: Nimotuzumab; Drug: cis-platinum; Radiation: IMRT combine with cisplatin concurrent chemotherapy; Drug: painkiller

control group

OTHER

cis-platinum, 30mg/m2/w, for 6 weeks IMRT, 66～70Gy (2Gy/F, 35F), for 6 weeks painkiller, three ladders pain analgesic

Drug: cis-platinum; Radiation: IMRT combine with cisplatin concurrent chemotherapy; Drug: painkiller

Interventions

Nimotuzumab DRUG

nimotuzumab group nimotuzumab, 200mg/w, for 6 weeks

Also known as: H-R3

nimotuzumab group

cis-platinum DRUG

30mg/m2/w, for 6 weeks

Also known as: cisplatin

control group; nimotuzumab group

IMRT combine with cisplatin concurrent chemotherapy RADIATION

IMRT, 66～70Gy (2Gy/F, 35F), for 6 weeks

control group; nimotuzumab group

painkiller DRUG

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.)

control group; nimotuzumab group

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.: lead
• Baotou Cancer Hospital: collaborator

Study Sites (1)

Baotou Cancer Hospital

Baotou, Inner Mongolia, 014000, China

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

nimotuzumab; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• BO HAN

  Baotou Cancer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 17, 2025
• Study Start: May 15, 2021
• Primary Completion: April 14, 2025
• Study Completion: April 14, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

CN (1)