drugset / Trial / NCT04890522

An Open-label, Multicentre, Phase II/III RCT of PFLL Versus GP Combined With JS001 as the First-line Therapy for mNPC

NCT04890522

RandomizedParallel-groupOpen-labelTreatment

Summary

The treatment of distant metastasis is a key challenge for nasopharyngeal carcinoma because of poor outcomes, among which, chemotherapy is the cornerstone. However, many studies reported the use of different chemotherapy regimens to prolong the survival of metastatic nasopharyngeal carcinoma, while few of them focused on how to reduce the side effects of chemotherapy or improve the life quality of patients. Blocking the immune checkpoint is one of the effective strategies of tumor immunotherapy. Thus, we sought to find a proper chemotherapy regimen combined with PD-1 antibody JS001.

Timeline

Start
2021-07-01
Primary completion
2023-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 80 mg/m2 Intravenous
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Triprilimab Monoclonal antibody 240 mg Intravenous
Subject fluorouracil Small molecule 200 mg/m2 Intravenous