NCT07496190

Becotatug Vedotin for LA-NPC With a Suboptimal Response to Induction Chemotherapy Combined With Immunotherapy

Becotatug Vedotin for Locoregionally Advanced Nasopharyngeal Carcinoma With a Suboptimal Response to Induction Chemotherapy Combined With Immunotherapy: A Prospective, Single-Arm, Phase II Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Nasopharyngeal Cancinoma (NPC)

Interventions

Type	Name	Description
DRUG	Becotatug vedotin	Becotatug vedotin during concurrent radiotherapy and the adjuvant phase
DRUG	Becotatug vedotin	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.

Timeline

• Start date: 2026-02-10
• Primary completion: 2032-02-10
• Completion: 2034-02-10
• First posted: 2026-03-27
• Last updated: 2026-04-13

Locations

1 site across 1 country: China