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Study of Fuzuloparib Combined With Arsenic Trioxide for Treating Women Aged 18 to 70 With Platinum-Resistant Relapsed Ovarian Cancer
Led by Xing Xie · Updated on 2024-12-04
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Ovarian cancer is a leading cause of death among gynecologic tumors, with many patients experiencing relapses and limited response durations to current treatments. This research aims to evaluate the effectiveness and safety of combining Fuzuloparib with Arsenic trioxide therapy in patients who have relapsed with platinum-resistant ovarian cancer. The study focuses on patients who have already undergone at least two platinum-based chemotherapy treatments and seeks to improve outcomes in those with homologous recombination proficiency who currently have low response rates to PARP inhibitor therapy. Participants will receive a combination of Fuzuloparib capsules and Arsenic trioxide tablets. Arsenic trioxide is taken orally at a dose of 0.27 mg nine times daily for 21 consecutive days followed by a one-week rest, while Fuzuloparib capsules are taken twice daily at 150 mg. This combination treatment is based on preclinical studies showing stronger tumor cell growth inhibition and increased cancer cell death compared to either drug alone. The study is conducted in phases 1 and 2 to assess this combined therapys potential benefits and safety. During the study, participants will be monitored for tumor response, progression-free survival, overall survival, and quality of life over up to 36 months. Safety will be assessed by tracking adverse reactions throughout treatment and up to 30 days after the last chemotherapy cycle. Quality of life is evaluated at baseline and before each new chemotherapy cycle up to six cycles. Researchers will use imaging and laboratory tests to measure tumor size and health status, ensuring close observation of treatment effects and participant well-being.
CONDITIONS
Brief Title
Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer
Research Team
Y
yuanming shen, PhD
X
xing xie, PhD
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