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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

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Arsenic Trioxide

Fuzuloparib Capsules plus table Arsenic Trioxide po

Arsenic trioxide Tablet : 0.27\*9 tid po consecutive 21 days with 1 week rest． Fuzuloparib Capsules: 150 mg bid po

Arsenic trioxide Tablet +Fuzuloparib Capsules

yuanming shen, PhD

xing xie, PhD

Xing Xie, PhD

Yuanming Shen, PhD

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.

To explore the efficacy and safety of Fuzuloparib in combination with Arsenic trioxide therapy in platinum-resistance relapsed Ovarian cancer patients.

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.

Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer

Fuzuloparib Plus Arsenic Trioxide in Patients With Platinum Resistance Relapsed Ovarian Cancer

ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria among patients with at least one target lesion. Activity was also described in women with nontarget lesions only and in women without any tumor lesion but with elevated CA-125 levels before starting treatment.

PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first.

Evaluate the adverse reactions rate of drugs assessed by number and severity of adverse events in the treatment.

according to the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30).The basic content of life quality assessment includes: physical health, mental health, social function, disease status and overall health perception.

Xing Xie

profressor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer	NCT04518501	Efficacy and Sa...	Arsenic trioxid...	18 Years - 70 Years	Women's Hospital School Of Medicine Zhejiang University
Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer	NCT04518501	Efficacy and Sa...	Arsenic trioxid...	18 Years - 70 Years	Women's Hospital School Of Medicine Zhejiang University
Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer	NCT04518501	Efficacy and Sa...	Arsenic trioxid...	18 Years - 70 Years	Women's Hospital School Of Medicine Zhejiang University

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