Patient eligibility
myocardial infarction, unstable angina pectoris, arrhythmia, impaired cardiac function, Tumors, glioma, cardiovascular and cerebrovascular diseases, hypertension
MYOCARDIAL INFARCTION, UNSTABLE ANGINA PECTORIS, ARRHYTHMIA, TRANSIENT ISCHEMIC ATTACK, BRAIN METASTASES, CENTRAL NERVOUS SYSTEM TUMORS, SOLID TUMORS, TUMORS, CEREBROVASCULAR ACCIDENT, GLIOMA, CONGESTIVE HEART FAILURE, ONCOLOGY, HYPERTENSION, LACUNAR INFARCTION
Eligible patients were ≥ 18 years of age with recurrent or advanced solid tumors confirmed by histology or cytology refractory to standard therapy or for which no effective therapy was available. Patients had at least one measurable lesion during the baseline period (primary central nervous system tumors were assessed as per the Response Assessment in Neuro-Oncology [RANO] criteria; other solid tumors were assessed as per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1). The time interval between the end of the last antitumor treatment and the first administration of SYHA1813 was ≥ four weeks for cytotoxic drugs, immunotherapy, macromolecular targeted drugs, and biological therapy; ≥ two weeks or five half-lives (whichever is longer) for oral small-molecule targeted drug therapy, anticancer traditional Chinese medicines or proprietary Chinese medicines; and ≥ four weeks for radiotherapy (≥ two weeks for palliative local radiotherapy for symptom relief). Other inclusion criteria included a Karnofsky Performance Status (KPS) of 60 or more for patients with central nervous system tumors, an Eastern Cooperative Oncology Group (ECOG) physical performance status of 0 to 2 for patients with other solid tumors, and a life expectancy of 12 weeks.Exclusion criteria included participation in other interventional clinical studies within four weeks, major surgery within four weeks, use of glucocorticoids at a dose equivalent to more than 5 mg dexamethasone within five days for glioma or brain metastases, and use of bevacizumab, ramucirumab, and other anti-VEGF/VEGFR antibodies within three months for glioma or brain metastases. Patients were also excluded if they had impaired cardiac function or clinically significant cardiovascular and cerebrovascular diseases, including but not limited to a history of myocardial infarction, congestive heart failure, and unstable angina pectoris within six months; cerebrovascular accident within six months (patients with transient ischemic attack or lacunar infarction with no clinical significance could be enrolled); hypertension uncontrollable after medication (repeated blood pressure measurement at least 1 h apart, and blood pressure 150/90 mmHg at two consecutive tests); uncontrolled arrhythmia requiring medical treatment; QTc interval > 470 ms on electrocardiogram (ECG) examination; or left ventricular ejection fraction < 50%.