NCT07459296

Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC

Becotatug Vedotin Combined With Sintilimab and Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma：A Multicenter, Randomized, Controlled, Phase 3 Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 266 (estimated)
• Sponsor: First Affiliated Hospital of Guangxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, controlled phase III clinical trial aiming to investigate the efficacy and safety of Becotatug Vedotin induction therapy followed by concurrent chemoradiotherapy (CCRT) combined with neoadjuvant and adjuvant sintilimab, versus gemcitabine plus cisplatin (GP) induction chemotherapy followed by CCRT, in the treatment of high-risk locally advanced nasopharyngeal carcinoma (LANPC). The study plans to enroll 266 patients with high-risk NPC (AJCC 9th edition, anyT N2-3M0 or T4N1M0), who will be randomly assigned to the experimental group or the control group at a 1:1 ratio.The primary endpoint is 3-year event-free survival (EFS), and the secondary endpoints include overall survival (OS), local-regional failure-free survival (LRFFS), distant metastasis-free survival (DMFS), objective response rate (ORR), adverse events, and quality of life.

Detailed description

This is a multicenter, randomized, controlled phase III clinical study targeting patients with high-risk locally advanced nasopharyngeal carcinoma (stage T1-4N2-3M0 or T4N1M0 per the 9th AJCC/UICC staging system), with a planned enrollment of 266 patients who will be randomized 1:1 into an experimental group and a control group under an open-label, stratified randomization design. The primary endpoint of the study is 3-year event-free survival (EFS), and the secondary endpoints include efficacy measures such as overall survival and locoregional recurrence-free survival, as well as safety and quality of life assessments; additionally, the study explores the predictive value of efficacy biomarkers including EGFR expression and combined positive score (CPS). The experimental group is administered neoadjuvant therapy with becotatug vedotin plus sintilimab for 3 cycles, followed by concurrent chemoradiotherapy with cisplatin combined with adjuvant sintilimab therapy for 9 cycles, while the control group receives induction chemotherapy with gemcitabine plus cisplatin (GP regimen) for 3 cycles followed by concurrent chemoradiotherapy with cisplatin. Intensity-modulated radiation therapy (IMRT) is uniformly adopted for all patients in both groups, with standardized target volume doses and normal organ dose constraints defined. The study has also formulated detailed protocols for drug dose adjustment and toxicity monitoring; treatment-related adverse events are graded and managed in accordance with the NCI-CTCAE v5.0 and RTOG/EORTC criteria, and the EORTC QLQ-C30 scale is used to evaluate patients' quality of life. The study aims to verify that the innovative treatment regimen of becotatug vedotin combined with sintilimab yields superior efficacy with a manageable safety profile compared with the conventional GP induction chemotherapy followed by chemoradiotherapy in patients with high-risk locally advanced nasopharyngeal carcinoma, thereby providing a novel treatment option for this patient population and supplementing high-level evidence-based medical evidence. Meanwhile, it explores relevant biomarkers to lay a foundation for individualized treatment.

Conditions

• Nasopharyngeal Carcinoma (NPC)

Interventions

Type	Name	Description
DRUG	Becotatug Vedotin	Becotatug vedotin 2.3 mg/kg will be given on Day 1 of induction therapy, once every 3 weeks for a total of 3 cycles.
DRUG	Sintilimab	In the induction treatment phase, sintilimab 200 mg will be administered on Day 1 of each induction cycle, once every 3 weeks, for a total of 3 cycles. In the adjuvant treatment phase, sintilimab 200 mg will be given on Day 1, initiated 3 weeks after the completion of radiotherapy, once every 3 weeks, for a total of 9 cycles.
DRUG	Cisplatin	Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
RADIATION	intensity-modulated radiotherapy	Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions
DRUG	Gemcitabine (GEM)	Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation.
DRUG	Cisplatin	Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation

Timeline

• Start date: 2026-03-05
• Primary completion: 2030-04-01
• Completion: 2032-04-01
• First posted: 2026-03-09
• Last updated: 2026-03-16

Locations

1 site across 1 country: China