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

Recurrent Nasopharyngeal Carcinoma Clinical Trial

Official title:
Phase Ib / II Study of Anlotinib Combined With Gemcitabine/Cisplatin in Previous Untreated Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

Clinical Trial 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.

Clinical Trial Description

In the phase Ib portion, an escalated dose cohort is recruited to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of anlotinib when given in combination with gemcitabine/cisplatin. The phase II portion is designed to characterize the efficacy and safety of the combination therapy in previous untreated patients with R/M-NPC. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03639467
Study type Interventional
Source Chinese Academy of Medical Sciences
Contact Yuankai Shi, MD
Phone +86 10 87788293
Email syuankaipumc@126.com;
Status Recruiting
Phase Phase 1/Phase 2
Start date September 18, 2018
Completion date August 15, 2023
View Details
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