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Efficacy and Safety Profile 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)
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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Start Date
February 1, 2026
Primary Completion Date
July 1, 2028
Completion Date
May 1, 2029
Last Updated
February 6, 2026
30
ESTIMATED participants
Combination Therapy with Becotatug Vedotin, Pucotenlimab, and Cisplatin
COMBINATION_PRODUCT
Lead Sponsor
Sir Run Run Shaw Hospital
NCT06980038
NCT05039801
Data Source & Attribution
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