Phase 1 dose-escalation study of apatinib and irinotecan in esophageal squamous cell carcinoma patients.

ABSTRACT:

Background

Apatinib, an inhibitor of vascular endothelial growth factor receptor (VEGFR), has been used to treat esophagogastric adenocarcinoma. However, the dosage of apatinib varies greatly in clinical practice, and its safety in esophageal squamous cell carcinoma (ESCC) patients is unclear. Therefore, we initiated a phase 1 dose-escalation trial to identify the maximum tolerated dose (MTD) of apatinib when combined with irinotecan in ESCC.

Methods

The trial had a standard 3+3 design. The dosage of irinotecan was fixed at 150 mg/m² repeated every 2 weeks, while the daily dosage of apatinib was escalated from 250 mg, to 500 mg, to 750 mg. Dose-limiting toxicity (DLT) was defined as grade 4 hematological or grade 3-4 non-hematological adverse events (AEs).

Resu

SUBMITTER: Jia J 

PROVIDER: S-EPMC8798775 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature