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

NCT ID: NCT06879691

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2025-04-14

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.

Detailed 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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nimotuzumab group

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

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: DRUG

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

cis-platinum

Intervention Type: DRUG

30mg/m2/w, for 6 weeks

IMRT combine with cisplatin concurrent chemotherapy

Intervention Type: RADIATION

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

painkiller

Intervention Type: 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

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

Group Type: OTHER

cis-platinum

Intervention Type: DRUG

30mg/m2/w, for 6 weeks

IMRT combine with cisplatin concurrent chemotherapy

Intervention Type: RADIATION

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

painkiller

Intervention Type: 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.)

Interventions

Nimotuzumab

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

Intervention Type: DRUG

cis-platinum

30mg/m2/w, for 6 weeks

Intervention Type: DRUG

IMRT combine with cisplatin concurrent chemotherapy

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

Intervention Type: RADIATION

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.)

Intervention Type: DRUG

Other Intervention Names

H-R3; cisplatin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baotou Cancer Hospital

OTHER

Sponsor Role: collaborator

Biotech Pharmaceutical Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BO HAN

Role: STUDY_DIRECTOR

Baotou Cancer Hospital

Locations

Baotou Cancer Hospital

Baotou, Inner Mongolia, China

Countries

China

Other Identifiers

IST-Nimo-N&C-2021-03

Identifier Type: -

Identifier Source: org_study_id