drugset / Trial / NCT07665190

Neoadjuvant EGFR-ADC Combined With Anti-PD-1 Monoclonal Antibody in Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma

NCT07665190

NaSingle-groupOpen-labelTreatment

Summary

This clinical trial aims to evaluate the efficacy and safety of Becotatug Vedotin (EGFR-ADC) in combination with Pucotenlimab(Anti-PD-1 Monoclonal Antibody) as neoadjuvant therapy for patients with Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma. The primary objective is the pathological complete response(pCR)rate following neoadjuvant therapy. The secondary objective includes the major pathological response(MPR)rate following neoadjuvant therapy, the objective response rate (ORR), Organ preservation rate, Surgery postponement rate, event-free survival (EFS), overall survival(OS), and safety.

Timeline

Start
2026-07-01
Primary completion
2027-10-31
Completion
2030-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Becotatug Vedotin Monoclonal antibody 2.3 mg/kg Intravenous
Subject Pucotenlimab Monoclonal antibody 200 mg Intravenous