drugset / Trial / NCT03639467

Study of Anlotinib Combined With Gemcitabine/Cisplatin in Advanced Nasopharyngeal Carcinoma

NCT03639467

Phase 1/2 Unknown 40 enrolled Chinese Academy of Medical Sciences
NaSingle-groupOpen-labelTreatment

Summary

Gemcitabine plus cisplatin (GC) is more effective than fluorouracil plus cisplatin in the treatment of recurrent or metastatic NPC (R/M-NPC). GC is the standard first-line chemotherapy regimen for this population. However, the median progression-free survival was only 7 months for GC regimen. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit, which has strong effect of anti-angiogenesis. This study is aim to evaluate the efficacy and safety of the combination regimen of anlotinib plus GC as first-line treatment for R/M-NPC.

Timeline

Start
2018-09-18
Primary completion
2021-08-22
Completion
2023-08-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Catequentinib Small molecule 8 mg Oral
Subject Catequentinib Small molecule 12 mg Oral
Background Cisplatin Other / unclassified 80 mg/m2 Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous