Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer

Status Recruiting

Clinical Trial Summary

Clinical Trial Description

Ovarian cancer is the leading cause of death from gynecologic tumors in the western world. Most patients have relapses, and responses to subsequent therapies are generally short-lived. Currently, the population that can benefit from PARPi is mainly focusing on BRCAm, then homologous-recombination deficiency patients. Limited data revealed the ORR was only 3-4% in homologous recombination proficiency patients with PARPi therapy. New treatments are urgently needed to improve patient outcomes. The investigators' studies have shown that combination therapy with Fuzuloparib and Arsenic trioxide demonstrated a synergistic anti-tumor effect in BRCAness/HR-proficiency ovarian cancer cells: Firstly, CCK8 and clone formation assays showed that the combination of Fuzuloparib and Arsenic trioxide produced notable tumor cell growth inhibition than either single agent in SKOV3 and CAOV3 cells. Further, the combination therapy resulted in significantly increased level of γ-H2AX and decreased level of RAD51 by IF.The investigators also found that combination therapy could remarkably induced cell apoptosis, which is associated with induction of cleave-PARP and reduction of p-AKT, when compared with either single drug. (Data not published) Therefore, the investigators hypothesis is that for those platinum-resistance relapsed patients who have received at least twice platinum-based chemotherapy, patients with combinate therapy will get 25% of ORR. And platinum-resistance in combination with Arsenic trioxide therapy is well tolerated. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04518501
Study type	Interventional
Source	Women's Hospital School Of Medicine Zhejiang University
Contact	yuanming shen, PhD
Phone	13588193832
Email	13588193832@163.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	July 1, 2020
Completion date	January 1, 2025

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