This exploratory clinical study will enroll patients with unresectable locally recurrent nasopharyngeal carcinoma to receive two cycles of becotatug vedotin plus a PD-1 monoclonal antibody, followed by sequential radiotherapy and PD-1 monoclonal antibody maintenance until disease progression or unacceptable toxicity. The study aims to evaluate the efficacy and safety of this treatment strategy.
Voluntarily participates in the study and provides written informed consent.
Aged 18-70 years, male or non-pregnant female, with an expected survival of ≥3 months and an ECOG performance status of 0 or 1.
Histologically or cytologically confirmed locally recurrent nasopharyngeal carcinoma, differentiated or undifferentiated carcinoma, corresponding to WHO type II or III, with clinical stage rT2-4N0-3M0, rIA-III according to the AJCC 9th edition.
Recurrence occurring more than 12 months after completion of initial radiotherapy, with no systemic or local antitumor treatment during this interval.
Patients with surgically resectable locally recurrent disease, including rT2 disease limited to the superficial parapharyngeal space and located more than 0.5 cm from the internal carotid artery, or rT3 disease limited to the floor of the sphenoid sinus and located more than 0.5 cm from the internal carotid artery and cavernous sinus.
Nasopharyngeal necrosis, radiation-induced brain injury, severe cervical fibrosis, or other CTCAE v5.0 Grade ≥3 radiation-related complications, with extremely high radiotherapy risk as assessed by the investigator.
Grade ≥2 peripheral neuropathy according to CTCAE v5.0.
Receipt of systemic chemotherapy within 3 weeks before the first dose of study drug; small-molecule targeted therapy within 2 weeks or 5 half-lives, whichever is longer, before the first dose; antitumor biologic therapy, macromolecular targeted therapy, immunotherapy, or major surgery within 4 weeks before the first dose, except for minor surgery within 2 weeks with complete recovery.