A Phase II Randomized Study Comparing PARP Inhibitor Maintenance Regimens in High-Risk Advanced Ovarian Cancer

未提供0 个研究点目标入组 80 人开始时间: 待定

适应症

试验速览

暂无简介。

•Patients meeting all of the following criteria will be eligible for enrollment: written informed consent has been obtained; patients have advanced ovarian cancer and have undergone interval debulking surgery (IDS) following neoadjuvant chemotherapy (NAC); optimal surgery has been achieved at IDS, defined as a maximum residual tumor diameter of 1 cm or less; homologous recombination deficiency (HRD)-positive status has been confirmed; no age restriction applies; Eastern Cooperative Oncology Group (ECOG) Performance Status is 0 or 1; and adequate hematologic and major organ function is present to safely initiate maintenance therapy following completion of neoadjuvant chemotherapy. Specifically, laboratory criteria include an absolute neutrophil count of 1,500/mm^3 or greater, a platelet count of 100,000/mm^3 or greater, hemoglobin of 9.0 g/dL or greater, AST and ALT no greater than 2.5 times the upper limit of normal (ULN), total bilirubin no greater than 1.5 times the ULN, and serum creatinine no greater than 1.5 times the ULN or estimated glomerular filtration rate (eGFR) of 50 mL/min or greater.

•Patients will be excluded if they have uncontrolled thromboembolic disease, uncontrolled hypertension, or an active synchronous malignancy.

发起方

未提供