Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer
ConditionEfficacy and Safety
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorXing Xie
About this trial
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.
Eligibility criteria
Qualifiers
18-70years old;
High grade (serous or endometrioid) epithelial ovarian cancers, fallopian tube or primary peritoneal carcinoma;
Patients received at least two lines of platinum-containing chemotherapy, with recurrence occurring within six months after the last chemotherapy dose, or were platinum-refractory patients who have undergone at least two cycles of platinum-based chemotherapy;
Measurable disease as per RECIST 1.1
Disqualifiers
Prior treatment with PARP inhibitors except under specific conditions: 1. Patients who previously received PARP inhibitor (PARPi) therapy without disease progression during treatment, but discontinued due to reasons such as treatment cost or adherence issues; 2. Patients who received only one prior PARPi therapy (excluding fuzuloparib), with maintenance therapy lasting ≥ 12 months. In both cases, the time since the last PARPi treatment must be >6 months prior to study enrollment;
Patients who had previously received >20% bone marrow radiotherapy in 1 week;
Other malignant tumors have been found in the past 5 years,except for cured cervical carcinoma in situ, non melanoma of the skin;
Uncontrolled systemic infection requiring anti-infective treatment;
Trial design
Treatments tested in this trial
- Arsenic trioxide Tablet +Fuzuloparib Capsules
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Xing Xie
Lead sponsor
Women's Hospital School Of Medicine Zhejiang University
Sponsor institution
Source ClinicalTrials.gov