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A Phase III Clinical Study of Tislelizumab Combined With GX Regimen Versus Tislelizumab Combined With GP Regimen in the First-line Treatment of Recurrence or Metastasis (R/M) Nasopharyngeal Carcinoma (NPC)
The study is being conducted to evaluate the safety and efficacy of tislelizumab combined with GX regimen versus tislelizumab combined with GP regimen in the first-line treatment of nasopharyngeal carcinoma.
Details
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 3 |
| Status | RECRUITING |
| Enrolment | 266 |
| Start date | 2023-12-01 |
| Completion | 2027-12 |
Conditions
- Nasopharyngeal Carcinoma
Interventions
- Tislelizumab combined with GX
- Tislelizumab combined with GP
Primary outcomes
- To compare the progression-free survival of tislelizumab combined with GX regimen and tislelizumab combined with GP regimen based on the ITT analysis set evaluated by the researchers according to RECIST v1.1. — up to approximately 3 years
Time from the date of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.
Countries
China