NCT06879691

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

A Randomized Controlled Trial on the Efficacy and Pain Impact of Nimotuzumab Combined with a Painkiller in Comprehensive Treatment of Advanced Squamous Cell Carcinoma of Head and Neck

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 171 (estimated)
• Sponsor: Biotech Pharmaceutical Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Nimotuzumab	nimotuzumab group nimotuzumab, 200mg/w, for 6 weeks
DRUG	cis-platinum	30mg/m2/w, for 6 weeks
RADIATION	IMRT combine with cisplatin concurrent chemotherapy	IMRT, 66～70Gy (2Gy/F, 35F), for 6 weeks
DRUG	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.)

Timeline

• Start date: 2021-05-15
• Primary completion: 2025-04-14
• Completion: 2025-04-14
• First posted: 2025-03-17
• Last updated: 2025-03-17

Locations

1 site across 1 country: China