NCT06301165

TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma

TPC Versus GP Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma, a Multi-center Phase II Randomized Trial
Sun Yat-sen University·Phase 2·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Nasopharyngeal Carcinoma
Drug/Device/Intervention
TPC induction chemotherapy
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Sun Yat-sen University
Location
Guangzhou,Guangzhou,Guangzhou,Guangzhou,Dongguan,Foshan,Shenzhen,Wuhan, China
Timeline & enrollment
Phase
Phase 2
Start date
Mar 19, 2024
End date
Dec 31, 2028
Enrollment
162 participants
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
Malignant neoplasm of nasopharynxMalignant neoplasm: Nasopharynx, unspecifiedMalignant neoplasm: Overlapping lesion of nasopharynxBenign neoplasm: NasopharynxMalignant neoplasm: Posterior wall of nasopharynx
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06301165
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06301165 through Pure Global AI's free database. This Phase 2 trial is sponsored by Sun Yat-sen University and is currently Recruiting. The study focuses on Nasopharyngeal Carcinoma. Target enrollment is 162 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.