TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma - Trial NCT06301165

Timeline & Enrollment

Primary Outcome

Progression-free survival

Summary

The NCCN guidelines recommend induction chemotherapy followed by concurrent chemoradiotherapy
 as the standard treatment for locoregionally advanced nasopharyngeal carcinoma (NPC).
 However, meta-analyses have shown significant survival differences between different
 induction chemotherapy regimens. How to choose an induction chemotherapy regimen and
 treatment course that ensures definitive therapeutic effects and low incidence of toxic side
 effects remains a hot spot in clinical research. Polymeric micellar paclitaxel are an
 innovative form of paclitaxel drugs, with high penetration and long retention effects, which
 can enter the vascularly disordered tumor microenvironment through passive targeting and form
 higher concentrations in tumor tissue. It remains to be investigated whether the TPC
 (paclitaxel, cisplatin and capecitabine) regimen based on polymeric micellar paclitaxel
 compared to the current standard first-line induction chemotherapy GP (gemcitabine,
 cisplatin) regimen can further improve therapeutic effects in high-risk patients with locally
 advanced disease. There is still a lack of head-to-head studies for comparison. This study
 aims to compare, through a prospective, parallel-controlled, randomized, open-label,
 multicenter phase II clinical trial, the TPC induction chemotherapy vs. the GP induction
 chemotherapy combined with concurrent chemoradiotherapy for the treatment of high-risk
 locoregionally advanced NPC (T4 or N2-3) in terms of 2-year progression-free survival,
 overall survival, overall response rate, toxic side effects, etc.

ICD-10 Classifications