This study is a Prospective, Single-arm, Phase II clinical trial. The purpose of this study is to find out if taking combination therapy of Senaparib and Bevacizumab is safe and works well for people with first-line maintenance therapy in newly diagnosed advanced homologous recombination proficient ovarian cancer, and explore relevant biomarkers for evaluating the efficacy of maintenance therapy through exosome. Researchers will look at the Progression-Free Survival, Overall Survival, safety, and any side effects.
The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up;
Age range of 18 to 75 years old (calculated from the day of signing informed consent);
Patients with newly diagnosed epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer confirmed by histopathology;
FIGO stage III-IV, stage III subjects must have undergone one optimal tumor reduction surgery (first cell reduction surgery or intermittent cell reduction surgery). Participants in Phase IV studies must have undergone biopsy and/or first-time cytoreductive surgery or intermittent cytoreductive surgery; Can provide 10 pathological white films for subsequent research;
Previous (within 5 years) or concurrent incurable malignant tumors, except for cured skin basal cell carcinoma, thyroid carcinoma, cervical carcinoma in situ, and breast cancer with no recurrence more than 3 years after the completion of radical surgery;
Have not previously used PARP inhibitors;
Those who are unable to swallow pills normally or have gastrointestinal dysfunction that may affect drug absorption, as determined by researchers;
Patients with a history of gastrointestinal perforation or major surgery within 4 weeks prior to the first use of medication; Patients with bleeding or bleeding events ≥ CTCAE grade 3, or with unhealed wounds, ulcers, or fractures;
Single group
Senaparib
Drug100mg qd
Bevacizumab
Drug7.5mg/kg q3w
PFS
Progression-free survival, according to RECIST v1.1
OS
Overall survival, according to RECIST v1.1
AEs
Adverse Events, according to CTCAE V5.0 criteria, During the trial, the adverse event record form should be truthfully filled in, including the occurrence time, severity, correlation with study treatment, duration, measures taken and outcome of the adverse event.
Detection of exosome related biomarkers
Screening period, maintenance treatment for 1 month, 3 months, and disease progression will be tested separately
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This trial is not recruiting at the moment. You can still explore other options:
