drugset / Trial / NCT04447612

Concurrent Chemoradiation and Durvalumab for Locoregionally Advanced Nasopharyngeal Carcinoma

NCT04447612 ↗

Phase 2 Unknown 118 enrolled The University of Hong Kong
RandomizedParallel-groupOpen-labelTreatment

Summary

The investigators propose a phase II randomized-controlled study on using durvalumab in combination with induction chemotherapy followed by concurrent chemoradiation and adjuvant durvalumab, compared to induction chemotherapy followed by concurrent chemoradiation for previously untreated locoregionally advanced stage III to IVA NPC. In parallel, the investigators will also perform collateral tumor and serum biomarker studies which will be correlated with the treatment response. The investigators will collect fresh tumour biopsies at pretreatment, then serially after induction chemotherapy and after concurrent chemoradiation to investigate the change in microenvironment of the tumour and the surrounding inflammatory cells before and after durvalumab. In addition, the investigators will also measure the change in number and intensity of PD-L1-positive circulating tumour cells (CTC) before and after durvalumab and evaluate their correlation with treatment response.

Timeline

Start
2020-06-01
Primary completion
2023-12-31
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Background Cisplatin Other / unclassified 100 mg/m2 Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous