NCT05397769

Envafolimab Plus Chemoradiotherapy for Locally Advanced NPC, a Prospective, Single Armed Phase II Trial.

Envafolimab Plus Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma, a Prospective, Single Armed Phase II Trial.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Patients diagnosed with locally advanced nasopharyngeal carcinoma will be recruited in this study. All the patients will get 3 cycles of GP+ Envafolimab for the induction chemotherapy. After that, the patients will receive concurrent chemoradiotherapy. Radiotherapy will be given by IMRT, under the dose of GTVnx 68-70Gy/30-33f, 5d/w,6-7w, during which, every patient would receive 2 cycles of DDP+Envafolimab as concurrent chemotherapy. Then patients would receive Envafolimab every 3 weeks for maintenance treatment for a year, until disease progression or intolerance of treatment. . We aim to evaluate the three years progression free survival of these patients by the combination of Envafolimab with curative chemoradiotherapy.

Conditions

• Locally Advanced Nasopharyngeal Carcinoma
• Envafolimab
• Induction Chemotherapy
• PD-L1

Interventions

Type	Name	Description
DRUG	Envafolimab Plus Chemoradiotherapy	Envafolimab was administrated with 300mg each time, every three weeks for a total of 22 cycles since the first day of induction chemotherapy.

Timeline

• Start date: 2022-06-08
• Primary completion: 2026-06-01
• Completion: 2026-12-31
• First posted: 2022-05-31
• Last updated: 2022-08-10

Locations

1 site across 1 country: China