Combining Fuzuloparib and Arsenic Trioxide for Ovarian Cancer Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy and safety of Fuzuloparib in combination with Arsenic trioxide for patients with platinum-resistant relapsed ovarian cancer. The study aims to improve outcomes for patients who have already undergone multiple lines of platinum-based chemotherapy and have limited treatment options. The methodology includes assessing tumor response through various assays and measuring specific biomarkers to evaluate the treatment's effectiveness. The trial targets patients with high-grade serous or endometrioid ovarian cancers who meet specific eligibility criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* ECOG 0-2;
* Life expectancy ≥12 weeks;
* Confirmation of BRCA1/2 mutation status;
* PARPi naive;
* LVEF ≥ 50%;
* Bone Marrow Function: ANC：≥1.5×109/L； PLT：≥100×109/L；Hb: ≥90g/L;
* Liver and renal function:Serum creatinine ≤ normal upper limit (ULN) 1.5times; aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ULN 2.5times, or \<ULN 5times in the presence of liver metastasis; total bilirubin (TBil) level≤ ULN 1.5 times, or ≤ ULN 2.5times if Gilbert's syndrome are present;
* The childbearing age subjects must agree to take effective contraceptive measures during the trial; the serum or urine pregnancy test must be negative, non-lactating;
* Signed the informed consent;

Exclusion Criteria:

* 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;
* Allergies to the Fuzuloparib or Arsenic Trioxide or their excipients or intolerant patients;
* Subjects with ≥2 grade peripheral neuropathy according to CTCAE V 4.03;
* Researchers think it is not suitable for enrolling.

Where it's running

• Women's Hospital School Of Medicine Zhejiang University
  Zhejiang, Hangzhou, China Recruiting

Study contacts

• Study coordinator: yuanming shen, PhD
• Email: 13588193832@163.com
• Phone: 13588193832

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.