This study is a multicenter, prospective, single-arm Phase II clinical trial evaluating the efficacy and safety of neoadjuvant therapy with TROP-2 ADC in combination with toripalimab for resectable locally advanced oral squamous cell carcinoma, followed by curative surgery and postoperative adjuvant radiotherapy or chemoradiotherapy.
Ages 18-75 (inclusive); no gender restrictions.
Histologically or cytologically confirmed locally advanced oral squamous cell carcinoma (AJCC 8th Edition stages III-IVA).
Resectable and having not previously received any antitumor therapy for oral squamous cell carcinoma.
At least one evaluable tumor lesion according to RECIST version 1.1.
Presence of precancerous lesions such as oral leukoplakia, erythroplakia, or lichen planus.
History of head and neck radiation therapy.
History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
Received other investigational drugs or treatments not yet approved for marketing within 4 weeks prior to the first administration of the study drug.
Shanghai East Hospital
Lead sponsor
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Huashan Hospital
Collaborator