Randomized phase II study of capecitabine plus cisplatin with or without sorafenib in patients with metastatic gastric cancer (STARGATE).

ABSTRACT:

Background

In this randomized phase II study, we evaluated the efficacy and safety of sorafenib in combination with capecitabine and cisplatin (XP) as first-line chemotherapy in advanced gastric cancer.

Patients and methods

Patients with metastatic gastric or gastroesophageal junction adenocarcinoma were randomized (1:1) to receive either sorafenib plus XP (S + XP) or XP alone. In cases of disease progression in the XP arm, crossover to sorafenib alone was allowed. The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall survival (OS), response rates, safety profiles, and biomarkers, and the response rates and PFS with secondline sorafenib alone after progression in the XP arm.

Results

Between Jan 2011 and Feb 2013, a total of

SUBMITTER: Ryu MH 

PROVIDER: S-EPMC10134272 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature