Safety and Efficacy
Patients were followed for 28 days after the last dose. Thereafter, patients were contacted every 6 months to monitor overall survival (OS). Safety evaluations (clinical and laboratory examinations) were conducted every 28 days, beginning from the first dose. AEs were graded according to revised Common Terminology Criteria for AEs, version 4.03. Efficacy evaluations with imaging were conducted at baseline, week 8, and every 8 weeks thereafter, except for patients who came off trial before 8 weeks or those for whom imaging assessment was deemed necessary due to symptoms of clinical progression. Response and progression were assessed using the revised RECIST guideline, version 1.1 (for details, see the trial protocol in 