Study design and participants
arrhythmia, fecal occult blood test, hematemesis, melena, coagulation abnormalities
UNCONTROLLED HYPERTENSION, ARRHYTHMIA, BRAIN METASTASES, MELENA, CARDIAC INSUFFICIENCY, ULCERATION, ONCOLOGY, CORONARY HEART DISEASE, GASTROINTESTINAL HEMORRHAGE
AHEAD was a prospective, single-arm, multicenter phase IV study which recruited participants from 150 sites in China. Eligible patients had an age between 18 and 75 years old; histologically or cytologically confirmed advanced gastric cancer or gastroesophageal junction adenocarcinoma with an extragastric measurable lesion per RECIST 1.1; an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0–2; adequate hematological and hepatic function; failure of at least two lines of chemotherapy. Additionally, patients with observable lesions, but not measurable, could be enrolled according to the judgment of the investigators at each site. Patients at risk of gastrointestinal hemorrhage, such as a history of hematemesis and melena within three months before enrollment, active ulceration combined with a positive fecal occult blood test (+ +), were excluded from the present study. Other exclusion criteria were uncontrolled hypertension, coronary heart disease, arrhythmia (including men with QTc interval > 450 ms or women with QTc interval > 470 ms), cardiac insufficiency, coagulation abnormalities, and evidence of brain metastases. The study was conducted in accordance with international harmonized guidelines for good clinical practice and the principles of the Helsinki Declaration.