Patients and study design
Tumors, active hepatitis, arrhythmia, Cancer
UNCONTROLLED HYPERTENSION, METASTASIS, ARRHYTHMIA, TUMORS, WEST, ONCOLOGY, HEART FAILURE, CORONARY ARTERY DISEASE, CANCER
This phase II prospective, single‐arm, open‐label, multicenter study was conducted at West China Hospital of Sichuan University, West China Fourth Affiliated Hospital of Sichuan University, Sichuan Cancer Hospital, and Sichuan Provincial People's Hospital. The study strictly adhered to the Helsinki provisions of the Declaration and obtained approval from the institutional review boards at each participating center. This trial is registered with The key inclusion criteria were as follows: (1) patients aged 65 years or older who were diagnosed with mCRC confirmed by histopathology; (2) refractory patients defined the patients who progressed after two or more lines of standard chemotherapy (irinotecan, oxaliplatin, and fluorouracil) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; concurrent administration of VEGF or epidermal growth factor receptor (EGFR) inhibitors during chemotherapy was permitted; (3) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or l; (4) able to take oral medication and expected survival time of at least 3 months; (5) presence of at least one measurable lesion in accordance with RECIST version 1.1; (6) informed consent and completed geriatric questionnaires at the time of enrollment; and (7) adequate organ and bone marrow function up to 2 weeks before enrollment.The primary exclusion criteria included: (1) prior treatment with VEGFR inhibitors; (2) presence of central nervous system metastasis; (3) concurrent occurrence of uncontrolled hypertension, coronary artery disease, arrhythmia, heart failure, active hepatitis (defined as HBV DNA ≥10