Pamiparib Combined with Surufatinib for the Neoadjuvant Treatment of Unresectable Ovarian Cancer: A Single-Arm, Prospective, Single-Center Clinical Study Protocol

Abstract

Abstract Background Ovarian cancer is a gynecological malignancy with a high incidence and mortality. Optimal tumor reduction surgery is crucial for improving the prognosis of advanced ovarian cancer patients. Traditional platinum-based neoadjuvant chemotherapy (NACT) can increase the chances of surgical treatment for advanced ovarian cancer and reduce the difficulty of surgery. However, NACT has limited benefits for patients. Poly (ADP-ribose) polymerase (PARP) inhibitors (PARPis) combined with antiangiogenic treatment increase the clinical benefits to ovarian cancer patients. Therefore, we hypothesize that PARPis combined with antiangiogenic neoadjuvant therapy (NAT) can improve the R0 resection rate of advanced ovarian cancer while avoiding platinum resistance caused by NACT. Methods This study is a prospective, interventional, single-arm, open-label, phase II clinical trial. Patients with stage III or IV advanced ovarian cancer, primary peritoneal cancer, and fallopian tube cancer (collectively referred to as ovarian cancer per the International Federation of Gynecology and Obstetrics (FIGO) staging 2018) who are unable to achieve R0 tumor reduction surgery after imaging or laparoscopic evaluation or cannot tolerate surgery will be recruited. The patient will receive NAT with three cycles of pamiparib combined with surufatinib (pamiparib: 40 mg, twice daily, 3 weeks per cycle, treatment for three cycles; surufatinib: 250 mg, once daily, 3 weeks per cycle, treatment for two cycles), followed by surgery. The main endpoint will be the assessment of the R0 resection rate. The secondary study endpoints will be the objective response rate (ORR), pathological complete response (pCR), event-free survival (EFS), overall survival (OS), and adverse events (AEs). Discussion This is the first prospective study to evaluate the efficacy and safety of PARPis combined with antiangiogenic therapy for newly diagnosed advanced ovarian cancer. Drug combinations are a key component in experimental design. We hope that this promising treatment strategy can provide new options for patients with advanced ovarian cancer. Trial registration ClinicalTrials.gov, NCT05652283. Registered on 27 November 2022.