Abstract 823TiP
Background
Ovarian cancer is one of the most common malignant tumors in female genital organs. The incidence rate is third highest and its mortality is the highest. In the treatment of ovarian cancer, 70% of patients will still relapse after chemotherapy, of which, about 25% isplatinum resistant relapse, which seriously affects the quality of life and prognosis of patients. At present, platinum-resistant ovarian cancer treatment is still a difficult problem. BRCA gene mutation is closely related to the occurrence and development of ovarian cancer. PARP inhibitors open the door to precision treatment of ovarian cancer. Although PARP inhibitors have achieved certain results in monotherapy for multiline recurrent ovarian cancer, there is no relevant data on drug-resistant ovarian cancer. To improve the objective response rate, this study was designed to investigate the efficacy and safety of PARP inhibitor (PARPi) fluzoparib combined with antiangiogenic drug apatinib in the treatment of platinum-resistant recurrent ovarian cancer.
Trial design
This is a prospective, one-arm, exploratory clinical study. It is estimated that 80 patients with pathologically confirmed high-grade serous ovarian cancer, fallopian tube cancer, and primary peritoneal carcinoma will be included from January 2021 to January 2023. After first-line or more chemotherapy, platinum resistance relapses. All patients will be treated with fluzoparib (150mg, bid, po) combined with apatinib (250mg, qd, po). The primary endpoint was objective response rate (ORR). Secondary endpoints were disease control rate (DCR), progression-free survival (PFS), survival time (OS), quality of life score (QoL) and drug safety. In this study, hierarchical analysis will be conducted according to BRCA or HRD gene status. In this study, the combination therapy of fluzoparib and small molecule antiangiogenesis drug apatinib may make platinum-resistant patients reverse drug resistance, resensitizing them to paclitaxel and platinum chemotherapy, reducing side effects, so as to benefit patients, and provide theoretical basis for doctors to treat platinum-resistant ovarian cancer.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Beijing Cisco Clinical Oncology Research Foundation.
Disclosure
All authors have declared no conflicts of interest.