drugset / Trial / NCT05520814

PD-1 Inhibitors Plus Chemoradiotherapy for Metastatic Nasopharyngeal Carcinoma: an Open-label Single-arm, Phase II Trial

NCT05520814

NaSingle-groupOpen-labelTreatment

Summary

programmed cell death-1 (PD-1) inhibitors has been recommended as the first-line treatment for recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), but progression-free survival (PFS) and overall survival (OS) was still unsatisfactory. Basic studies have already confirmed PD-1 inhibitors had concurrent synergistic effect with chemotherapy and radiotherapy. Few studies concerned about the treatment pattern for concurrent PD-1 inhibitors combination with chemoradiation for R/M NPC. There was still much uncertainties about the timing, fraction dose and total dose for PD-1 inhibitors combination with radiation. Therefore, we aimed to explore the substantial effect and toxicity of this new pattern for R/M NPC.

Timeline

Start
2018-08-01
Primary completion
2023-12-31
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Carrilizumab Monoclonal antibody 200 mg
Subject Tirelizumab Monoclonal antibody 200 mg
Subject Toripalimab Monoclonal antibody 240 mg
Background Carboplatin Small molecule 5 unknown
Background Cisplatin Other / unclassified 80 mg/m2
Background Gemcitabine Small molecule 1 g