Becotatug Vedotin Plus Pucotenlimab and Platinum Chemotherapy in Locally Advanced Epidermal Growth Factor Receptor (EGFR)-Positive Head and Neck Squamous Cell Carcinoma
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This prospective, single-arm, multicenter phase II trial aims to evaluate the efficacy and safety of neoadjuvant beccotatug vedotin combined with pucotenlimab and cisplatin in patients with locally advanced epidermal growth factor receptor (EGFR)-positive head and neck squamous cell carcinoma (HNSCC). A total of 40 treatment-naive patients aged 18-70 years with stage III-IV (AJCC 8th edition) EGFR-positive HNSCC will be enrolled. Participants will receive three 3-week cycles of the triple-drug regimen. Tumor response will be reassessed after cycle 3 using RECIST v1.1. Patients achieving a complete or partial response (CR/PR) may proceed to de-escalation surgery followed by definitive chemoradiotherapy, or to definitive chemoradiotherapy alone; non-responders will undergo radical surgery with or without radiotherapy/chemoradiotherapy, or definitive chemoradiotherapy, as determined by multidisciplinary team (MDT) discussion. The primary endpoint is objective response rate (ORR). Secondary endpoints include major pathological response (MPR), pathological complete response (pCR), disease control rate (DCR), 2-year progression-free survival (PFS), 2-year overall survival (OS), quality of life, and safety. This study aims to provide preliminary evidence on the feasibility and activity of this novel triple combination in the neoadjuvant setting, potentially offering a new treatment paradigm to improve long-term outcomes and reduce recurrence.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony histologicznie rak płaskich komórek głowy i szyi (jama ustna, gardło, krtań) z dodatnim markerem EGFR
- •Stadium zaawansowane (III-IV) wg skali AJCC
- •Wiek 18-70 lat
- •Pacjent nigdy wcześniej nie był leczony na ten nowotwór
- •Ogólny stan zdrowia pozwalający na tolerowanie leczenia (skala ECOG 0-1)
- •Wystarczająca funkcja nerek, wątroby i krwiotwórczych układów
- •Chęć uczestnictwa i możliwość uczęszczania na wizyty
✗ Disqualifies
- •Ciężka alergia na monoclonalne przeciwciała lub leki immunologiczne
- •Schorzenia autoimmunologiczne lub napady padaczkowe
- •Nowotwór rozsiany lub drugi jednocześnie istniejący nowotwór
- •Zaburzenia krzepnięcia krwi lub aktualne stosowanie leków rozcieńczających krew
- •Poważne problemy z sercem lub płucami
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Last updated (source)
- September 10, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (2)
Sun Yat-sen University Cancer Center
Guangzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Trial contact
Zhongyu Wang, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/11/2026.
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