drugset / Trial / NCT05397769

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

NCT05397769

Phase 2 Recruiting 36 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-06-08
Primary completion
2026-06-01
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Envafolimab Monoclonal antibody 300 mg Subcutaneous