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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Aged ≥ 18, male or female;

Histopathologically confirmed Hypopharyngeal Squamous Cell Carcinoma;

Surgically resectable, Clinical Stage III or IV and no distant metastasis (AJCC 8th edition);

Disqualifiers

Patients with distant metastasis;

Patients with uncontrolled severe medical conditions;

Patients with a history of allergy or hypersensitivity to any component of monoclonal antibody therapies;

Uncontrolled cardiac clinical symptoms or diseases;

Trial design

Treatments tested in this trial

  • Becotatug Vedotin and Pucotenlimab

Treatment groups

52 Participants
are divided into 1 treatment group