drugset / Trial / NCT04850235

Nab-paclitaxel Based TPX Neoadjuvant Chemotherapy for NPC Patients: a Dose-escalation Study

NCT04850235 ↗

Phase 1 Unknown 36 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

Summary

Neoadjuvant chemotherapy followed by concurrent chemoradiation (CCRT) has been recommended in the treatment of locoregionally-advanced nasopharyngeal carcinoma (NPC), with docetaxel, cisplatin (DDP) and 5-fluorouracil (5-Fu) shown to be an effective regimen. Capecitabine is the precursor drug of 5-fluorouracil, and has been used in replace of 5-fluorouracil in NPC patients. Nab-paclitaxel (Nab-PTX) is a novel albumin-bound paclitaxel with a superior therapeutic index to docetaxel. We sought to find out the efficacy of Nab-PTX in three-drug triplet (Nab-PTX, DDP and capecitabine) and decide the best administration dose of Nab-PTX.

Timeline

Start
2021-04-15
Primary completion
2022-12-31
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Nab-paclitaxel Small molecule 150 mg/m2 —
Subject Nab-paclitaxel Small molecule 175 mg/m2 —
Subject Nab-paclitaxel Small molecule 200 mg/m2 —
Subject Nab-paclitaxel Small molecule 225 mg/m2 —
Subject Nab-paclitaxel Small molecule 250 mg/m2 —