Fluzoparib Combined With Dalpiciclib for Platinum Resistant Recurrent Ovarian Cancer

• Overall Design: This trial is a single-center, prospective, single-arm, phase II clinical trial to evaluate the safety and efficacy of combination therapy of Fluzoparib combined With Dalpiciclib for platinum-resistant recurrent ovarian cancer.
• Experimental observation indicators: 1) Main indicators: progression-free survival (PFS), 2) Other indicators: overall survival (OS), objective response rate (ORR), and adverse reactions.
• Sample size calculation: The median PFS of platinum-resistant recurrent ovarian cancer patients is 3.8 months. In comparison, the experimental group is expected to have a median PFS of 7 months, with an alpha value of 0.05. Following up for 1 year and considering a 10% dropout rate, this study plans to include 30 platinum-resistant recurrent ovarian cancer patients.
• Data Processing: Enter data and use SPSS statistical software for statistical analysis. Statistical analyst: Clinical Statistics Department of Fudan University Cancer Hospital. Mailing address: 270 Dong'an Road, Shanghai.

Inclusion criteria

• Age≥18 years old;
• Sign the informed consent form;
• Histologically-confirmed epithelial ovarian or fallopian-tube cancer or primary peritoneal cancer.
• Tumor recurrence or progression within 6 months after using platinum-based drugs;

Exclusion criteria

• Any uncontrolled medical condition that may put the patient at high risk during treatment .
• Receipt of any other investigational medicinal product within the last 30 days before randomization.
• Patients with ovarian cancer excluded by pathological or clinical diagnosis;
• Physical intolerance patients;
• Patients who are unwilling to participate in the clinical trial.