Actively Recruiting
Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer
Led by Xing Xie · Updated on 2024-12-04
50
Participants Needed
1
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 70 years old
- Diagnosis of high-grade (serous or endometrioid) epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma
- Received at least two lines of platinum-containing chemotherapy with recurrence within six months or platinum-refractory after at least two cycles
- Measurable disease according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 12 weeks
- Confirmed BRCA1 or BRCA2 mutation status
- No prior treatment with PARP inhibitors
- Left ventricular ejection fraction (LVEF) of 50% or higher
- Bone marrow function: absolute neutrophil count (ANC) ≥1.5 x 10⁹/L; platelet count (PLT) ≥100 x 10⁹/L; hemoglobin (Hb) ≥90 g/L
- Liver and kidney function within specified limits (serum creatinine, AST, ALT, total bilirubin)
- For women of childbearing age: agreement to use effective contraception and negative pregnancy test
- Signed informed consent form
You will not qualify if you...
- Prior PARP inhibitor treatment except specific cases with no disease progression and last treatment over 6 months ago
- More than 20% bone marrow radiotherapy within one week prior
- Other malignant tumors within past 5 years except cured cervical carcinoma in situ or non-melanoma skin cancer
- Uncontrolled systemic infection requiring treatment
- Allergies or intolerance to Fuzuloparib, Arsenic trioxide, or their components
- Peripheral neuropathy of grade 2 or higher
- Investigator judgment that participation is unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Women's Hospital School Of Medicine Zhejiang University
Zhejiang, Hangzhou, China, 310006
Actively Recruiting
Research Team
Y
yuanming shen, PhD
CONTACT
X
xing xie, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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