NCT07354984

A Single-Arm Phase II Clinical Study of Docetaxel Combined With Nimotuzumab and Pucotenlimab as Second-Line and Beyond Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm Phase II trial designed to evaluate the efficacy and safety of Docetaxel, Nimotuzumab, and Pucotenlimab combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma who have failed prior PD-1/PD-L1 inhibitor and platinum-based therapies, for second-line and later-line treatment.

Conditions

• Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Drug Combination Therapy	\[Docetaxel 75mg/m2 + Nimotuzumab 400mg + Pucotenlimab 200mg\], intravenous infusion, Day 1, every 3 weeks, for 4-6 cycles (exact number determined by investigator assessment). Maintenance Regimen: \[Nimotuzumab 400mg + Pucotenlimab 200mg\], intravenous infusion, Day 1, every 3 weeks, until protocol-defined treatment endpoints are reached. Maintenance Therapy Eligibility: Subjects who meet both criteria after the last induction cycle: No disease progression confirmed by imaging and investigator assessment, and/or absence of intolerable toxicity.

Timeline

• Start date: 2026-01-01
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

1 site across 1 country: China