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.
Single group
Becotatug Vedotin
DrugBecotatug vedotin will be administered at 2.0 mg/kg intravenously on Day 1 every 3 weeks for 2 cycles as induction therapy, in combination with a PD-1 monoclonal antibody.
Toripalimab
DrugToripalimab will be administered at 240 mg intravenously on Day 1 every 3 weeks. Toripalimab is one of the optional PD-1 monoclonal antibodies in this study and will be used as an alternative to camrelizumab, not in combination with camrelizumab. It will be given during induction therapy, concurrently with radiotherapy, and as maintenance therapy after radiotherapy until disease progression or unacceptable toxicity.
Camrelizumab
DrugCamrelizumab will be administered at 200 mg intravenously on Day 1 every 3 weeks. Camrelizumab is one of the optional PD-1 monoclonal antibodies in this study and will be used as an alternative to toripalimab, not in combination with toripalimab. It will be given during induction therapy, concurrently with radiotherapy, and as maintenance therapy after radiotherapy until disease progression or unacceptable toxicity.
Intensity-Modulated Radiotherapy
DrugIntensity-modulated radiotherapy will be delivered once daily, 5 days per week. Prescribed doses are 60 Gy in 27 fractions to PTVnx, 60-64 Gy in 27 fractions to PTVnd, and 54 Gy in 27 fractions to PTV1.
Objective response rate
The proportion of participants who achieve a complete response (CR) or partial response (PR), as assessed by the investigator according to RECIST v1.1, from the first dose until disease progression, initiation of new anticancer therapy, death, or the last tumor assessment, whichever occurs first.
Duration of Response (DoR)
For participants who achieve a confirmed complete response (CR) or partial response (PR), duration of response is defined as the time from the first documented CR or PR to the first documented disease progression or death from any cause, whichever occurs first.
Locoregional Recurrence-Free Survival (LRFS)
Locoregional recurrence-free survival is defined as the time from the first dose to the first documented locoregional recurrence/progression or death from any cause, whichever occurs first.
Treatment-Related Adverse Events
Treatment-related adverse events will be assessed and graded according to NCI-CTCAE v5.0. The incidence and severity of adverse events, Grade 3 or higher adverse events, serious adverse events, and adverse events leading to dose modification, treatment interruption, or treatment discontinuation will be summarized.
Overall Survival (OS)
OS is defined as the time from the first dose to death from any cause. Participants who are alive will be censored at the date of last confirmed survival status.
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