NCT07353723

Nimotuzumab Combined With Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer

A Pilot Study to Assess Feasibility and Preliminary Efficacy of Neoadjuvant Nimotuzumab, Toripalimab, and Chemotherapy in Locally Advanced Tonsillar Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective,single-arm,Phase II clinical study to designed to evaluate the efficancy and safety of nimotuzumab Combined with Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer

Detailed description

This study is a prospective,single-arm,Phase II clinical study to evaluate the efficancy and safety of nimotuzumab Combined with Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer,The study aims to explore whether nimotuzumab Combined with Toripalimab and Chemotherapy for Locally Advanced Tonsillar Cancer, can improve the pathological complete response (pCR) and overall survival rate(OS) compared with the historical data. The study plans to enroll approximately 10 patients at Tangdu Hospital and expected to completed enrollment within 1 yeasrs,within an additional 5 years follow-up for the label-enrolled subject.

Conditions

• Head & Neck Cancer

Interventions

Type	Name	Description
DRUG	Nimotuzumab	treatment Regimen:Nimotuzumab was administered by intravenous infusion at a dose of 400 mg,d1, Q3W,for 2-4 cycles Other Name:
DRUG	Toripalimab	treatment Regimen:Toripalimab was administered by intravenous infusion at a dose of 240 mg,d1,Q3W,for 2-4 cycles
DRUG	Nab-paclitaxel	treatment Regimen:Nab-paclitaxel was administered by intravenous infusion at a dose of 260mg/m² ,d1, Q3W,for 2-4 cycles
DRUG	carboplatin	treatment Regimen: Carboplatin dosage was calculated using the Calvert formula (dose = target AUC × \[GFR + 25\]), d1,IV,Q3W,for 2-4 cycles

Timeline

• Start date: 2025-11-15
• Primary completion: 2026-11-15
• Completion: 2031-11-30
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: China