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NOT YET RECRUITING
NCT07665190
PHASE2

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

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Phase II Clinical Trial of Neoadjuvant Becotatug Vedotin Combined With Pucotenlimab in Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2026-07-01

Completion Date

2030-12-31

Last Updated

2026-06-24

Healthy Volunteers

No

Interventions

DRUG

Becotatug Vedotin and Pucotenlimab

Neoadjuvant therapy: Becotatug Vedotin is dosed based on the participant's body weight. In this study, the dosing regimen is 2.3 mg/kg, administered via intravenous infusion on Day 1 of each cycle, once every 3 weeks (Q3W), for a total of 3 treatment cycles. The infusion time for Becotatug Vedotin should be no less than 60min, and it is recommended to be controlled within 60 to 90min. Pucotenlimab is administered at a fixed dose of 200 mg per infusion, via intravenous infusion on Day 1 of each cycle, once every 3 weeks (Q3W), for a total of 3 treatment cycles, with an infusion duration of 60min (±15 min). When Becotatug Vedotin and Pucotenlimab are administered on the same day, Pucotenlimab is generally given first, followed by Becotatug Vedotin, with an interval of no less than 30min between the two infusions.

Locations (1)

Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin 300000

Tianjin, Tianjin Municipality, China