drugset / Trial / NCT04004871

Induction Chemotherapy With Nab-paclitaxel, Cisplatin and Fluorouracil for Locoregionally Advanced Nasopharyngeal Carcinoma

NCT04004871 ↗

NaSingle-groupOpen-labelTreatment

Summary

Nasopharyngeal carcinoma (NPC) is commonly observed in southern China, particularly in the Pearl River delta area and the Xijiang River basin in the Guangdong and Guangxi provinces, with an incidence rate as high as 25-50 per 100,000. The National Comprehensive Cancer Network guidelines (version 1, 2018), have recommended use of induction chemotherapy followed by CCRT as category 2A for NPC, especially the TPF regimen as category 1 for EBV-associated disease. The nanoparticle albumin-bound paclitaxel (Nab-paclitaxel) is a promising new agent with more efficient entry to the tumor microenvironment and preferential uptake by cancer cells. Superior activity of Nab-paclitaxel regimens without the necessity for antianaphylactic pretreatments has been shown in various solid tumors compared with the traditional solvent-based paclitaxel-based ones. However, the safety and efficacy of combination of Nab-paclitaxel, cisplatin and Fluorouracil (APF) has not been determined in patients with locoregionally advanced NPC. In this prospective, Multi-centeric, Open, Non-controlled phase II clinical trial, investigators perform an exploratory study to the efficacy and Safety of APF.

Timeline

Start
2019-03-28
Primary completion
2022-03-29
Completion
2025-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 60 mg/m2 —
Subject Nab-paclitaxel Small molecule 200 mg/m2 —
Subject fluorouracil Small molecule 600 mg/m2 —