Clinical Trial

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

Study acronym: RESERVE-HC
Recruiting Phase 2
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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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-17
Trial Details
NCT Number NCT07665190
Lead Sponsor Tianjin Medical University Cancer Institute and Hospital
Conditions Hypopharyngeal Squamous Cell Carcinoma
Enrollment 52 participants
Start Date 2026-07-01
Primary Completion 2027-10-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-16