A Phase 2 interventional study of Becotatug vedotin and Becotatug vedotin in Nasopharyngeal Cancinoma (NPC), sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
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.
Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1. 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.
Drug: Becotatug vedotin
Becotatug vedotin during concurrent radiotherapy and the adjuvant phase
1. 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.
Time frame: 3 years
Overall survival
Overall survival is calculated from the date of treatment initiation to death from any cause.
Time frame: 3 years
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.
Time frame: 3 years
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.
Time frame: 3 years
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).
Time frame: 3 years
Incidence of late toxicity as assessed by the Late Radiation Morbidity Scoring Scheme of the Radiation Therapy Oncology Group
Late adverse events (those occurring \>1 year after randomisation) are graded according to the Late Radiation Morbidity Scoring Scheme of the Radiation Therapy Oncology Group.
Time frame: 3 years
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