Study design and participants
intestinal obstruction, Tumors, arterial/venous thrombosis, post-gastrointestinal, Cancer
ABNORMAL COAGULATION, UNCONTROLLED HYPERTENSION, CHRONIC DIARRHEA, INTESTINAL OBSTRUCTION, TUMORS, BLEEDING TENDENCY, ONCOLOGY, CANCER
This was a single-arm, open-label phase II study conducted at Sun Yat-sen University Cancer Center (SYSUCC). Eligible patients were aged 18–70 with histologically proven recurrent and/or metastatic NPC and had at least one measurable lesion at baseline according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. All patients should have received at least first-line platinum-containing chemotherapy and progressed after it. Other inclusion criteria included an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2 and adequate hematological, renal, and hepatic functions. Patients were excluded if they had participated in other clinical trials within 4 weeks before the study, had received radiotherapy on the same site for twice or more, or had received the treatment with VEGFR small-molecule TKIs, such as famotidine, sorafenib, sunitinib, regofinib, anlotinib, or fruquintinib. Patients who exhibited a bleeding tendency, including important blood vessel invasion, abnormal coagulation, and/or a history of arterial/venous thrombosis within 6 months, or those with poorly controlled hypertension using a single anti-hypertensive drug were excluded. Patients with multiple factors affecting oral administration and absorption of drugs, such as being unable to swallow, being post-gastrointestinal resection, having chronic diarrhea, and/or intestinal obstruction were also excluded. The detailed inclusion and exclusion criteria can be found in the study protocol.This study was approved by the Ethics Committee of SYSUCC, and the study was conducted in accordance with the Declaration of Helsinki. All participants provided written informed consent upon enrollment.