Rivoceranib in Patients With Metastatic Thymic Epithelial Tumor

PURPOSE: To evaluate the efficacy and safety of Rivoceranib in patients with metastatic thymic epithelial tumors who developed resistance on first-line therapy.

Study Design: Patients with histologically confirmed metastatic thymic epithelial tumors who meet the inclusion/exclusion criteria will be enrolled in this study. In Stage 1, 18 subjects will be enrolled to receive study medication. If a tumor response is observed in at least 5 of these subjects, the study will proceed to Stage 2 to enroll the remaining subjects, or the study will be stopped early due to lack of clinical benefit of the investigational product. The trial will be considered clinically valid if a response is observed in 11 or more subjects out of a total of 33 subjects. Investigational product(Rivoceraniv 700 mg) will be administered until disease progression, development of intolerable adverse events, death, withdrawal of consent by the subject, or when, in the opinion of the principal investigator, it is inappropriate or impossible to continue the study. Imaging studies (CT or MRI) will be performed every 8 weeks (+,- 1 week) for C1D1 through 12 months and every 12 weeks (+,- 1 week) after 12 months, and the results will be used to assess tumor response according to RECIST v1.1 criteria. Safety will be assessed at C1D1, C1D7, and each scheduled visit thereafter.