Based on the short-term efficacy and plasma EBV DNA levels following immuno-induction chemotherapy, patients with locally advanced nasopharyngeal carcinoma who derive different benefits from this treatment can be identified. For high-risk patients who do not respond to immuno-induction chemotherapy (defined as EBV DNA \>0 copies/mL or imaging response evaluation showing SD/PD after immuno-induction chemotherapy), the addition of becotatug vedotin, which has a different mechanism of action, during concurrent radiotherapy and the adjuvant phase may improve patient survival. Based on the above research and background, the investigators plan to conduct the first prospective, single-arm, phase II clinical study of becotatug vedotin in patients with locally advanced nasopharyngeal carcinoma who are suboptimal responsive to immuno-induction chemotherapy, aiming to obtain sufficient evidence-based medical data to provide an additional treatment option for the concurrent and adjuvant phases of nasopharyngeal carcinoma.
Voluntary participation and written informed consent must be signed.
Age between 18 and 70 years, male or non-pregnant female.
Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
Stage Any T N2-3 or T4N1 (AJCC 9th edition), with no distant metastasis, and previously untreated nasopharyngeal carcinoma.
Patients with recurrent or distant metastatic nasopharyngeal carcinoma.
Pathological diagnosis of keratinizing squamous cell carcinoma (WHO Type I).
Patients who have previously received radiotherapy or systemic chemotherapy.
Women who are pregnant or breastfeeding, or individuals of childbearing potential who are not using effective contraception.
Single group
Becotatug vedotin
DrugBecotatug vedotin during concurrent radiotherapy and the adjuvant phase
Becotatug vedotin
Drug1. Induction Chemotherapy (TPP Regimen) Docetaxel 75 mg/m² d1 + Cisplatin (DDP) 75 mg/m² d1 + PD-1 inhibitor , administered every 3 weeks for a total of 3 cycles. 2. Concurrent Radiotherapy (Becotatug vedotin + IMRT) Concurrent radiotherapy commences 3 weeks after the completion of induction chemotherapy: Becotatug vedotin 2.3 mg/kg d1, starting on the first day of radiotherapy, administered every 3 weeks during the radiotherapy period for a total of 3 cycles. The radiotherapy technique employed is intensity-modulated radiotherapy (IMRT). 3. Adjuvant Therapy Adjuvant therapy commences 4-6 weeks after the completion of radiotherapy: Becotatug vedotin 2.3 mg/kg d1, administered every 3 weeks for a total of 3 cycles.
Progression-free survival
Progression-free survival is calculated from the date of treatment initiation to the date of documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.
Overall survival
Overall survival is calculated from the date of treatment initiation to death from any cause.
Locoregional recurrence-free survival
Locoregional recurrence-free survival is calculated from the date of treatment initiation to the date of documented locoregional recurrence or death from any cause.
Distant metastasis-free survival
Distant metastasis-free survival is calculated from the date of treatment initiation to the date of documented distant metastasis or death from any cause.
Incidence of acute toxicity as assessed by CTCAE v5.0
Acute adverse events (those that occurred within 1 year of randomisation) are graded according to the Common Terminology Criteria for Adverse Events (version 5.0).
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