Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer

Korábbi kezelés

• 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;

Más betegség

• 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;

Egyéb

• Subjects with ≥2 grade peripheral neuropathy according to CTCAE V 4.03;
• Researchers think it is not suitable for enrolling.

• 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;