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RECRUITING
NCT06177301
PHASE3

Tislelizumab Plus GX Versus Tislelizumab Plus GP in the Treatment of R/M NPC

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

266

Start Date

2023-12-01

Completion Date

2027-12

Last Updated

2025-08-14

Healthy Volunteers

No

Interventions

DRUG

Tislelizumab combined with GX

Tislelizumab:200mg vgtt,q3w;treatment until disease progression, patients withdrawal of informed, or intolerable toxicity. Gemcitabine:1000mg/m2, vgtt, d1,8, q3w, repeat 4-6 cycles. Capecitabine: 1000mg/m2, bid,po, d1-14, q3; treatment until disease progression, patients withdrawal of informed, or intolerable toxicity.

DRUG

Tislelizumab combined with GP

Tislelizumab: 200mg vgtt,q3w;treatment until disease progression, patients withdrawal of informed, or intolerable toxicity. Gemcitabine: 1000mg/m2, vgtt, d1,8, q3w, repeat 4-6 cycles; Cisplatin: 80mg/m2, ivgtt, d1 (high-dose cisplatin antiemetic and hydration regimen), q3w,repeat 4 \~ 6 cycles.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China