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.
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);
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;
Single group
Becotatug Vedotin and Pucotenlimab
DrugNeoadjuvant 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). Becotatug Vedotin and Pucotenlimab are administered on the same day, Pucotenlimab is given first, followed by Becotatug Vedotin, with an interval of no less than 30min between the two infusions.
Pathological Complete Response(pCR) Rate
The proportion of participants with no residual tumor cells in the resected primary tumor specimen after the completion of neoadjuvant therapy.
Major Pathological Response(MPR) Rate
The proportion of participants who achieve a major pathological response, defined as residual viable tumor cells ≤ 10% in the resected primary tumor specimen following neoadjuvant therapy.
Objective Response Rate（ORR）
The proportion of participants who achieve a complete response (CR) or partial response (PR) as assessed by RECIST version 1.1 after completion of neoadjuvant therapy.
Event-Free Survival (EFS)
The time from the start of study treatment to the first occurrence of any of the following events, including but not limited to: disease progression precluding surgical treatment, local recurrence or distant metastasis, or death from any cause.
Overall Survival(OS)
The time from the start of study treatment to death from any cause.
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