This clinical trial aims to evaluate the efficacy and safety of Becotatug Vedotin (EGFR-Targeting ADC) in combination with Pucotenlimab and Cisplatin as neoadjuvant therapy for patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
The primary objective is to assess whether this combination therapy improves the pathological complete response (pCR) rate and to evaluate its safety and tolerability. The secondary objective includes evaluating 1-year disease-free survival (DFS) rates and major pathological response (MPR) rates in patients treated with this combination therapy.
Main Questions This Trial Aims to Answer:
1. Does the combination of Becotatug Vedotin, Pucotenlimab, and Cisplatin lead to higher rates of pathological complete response (pCR) and major pathological response (MPR) in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC)? 2. What are the safety and tolerability profiles of the combination therapy? 3. Does the treatment improve disease-free survival at 1 year after treatment?
What Participants Will Do:
Treatment: Participants will receive Becotatug Vedotin (EGFR-Targeting ADC), Pucotenlimab, and Cisplatin as a combination therapy in the neoadjuvant setting.
Treatment Duration: Treatment will last approximately 6-12 weeks, depending on the patient's individual regimen.
Follow-up Visits: Participants will attend routine check-ups for safety evaluations and pathological assessments approximately 7 weeks after completing neoadjuvant therapy.
Outcomes: Researchers will assess pathological complete response (pCR), major pathological response (MPR), and 1-year disease-free survival (DFS) following treatment.
Aged 18-70 years (inclusive).
Histopathologically confirmed Stage III/IVA head and neck squamous cell carcinoma (HNSCC) of the oropharynx, oral cavity, hypopharynx, or larynx (per 8th edition AJCC Cancer Staging Manual).
Measurable primary lesions per RECIST v1.1.
Treatment-naive (no prior anti-tumor therapy for current disease).
Cachexia or multiple organ failure.
Active autoimmune disease of any type.
Concomitant second primary malignancy (e.g., esophageal cancer).
Severe active infection requiring systemic therapy.