NCT06081595
Fluzoparib Combined With Apatinib in Relapsed Ovarian Carcinoma Maintenance Treatment
Not Yet Recruiting · Phase 2 · Jin Li · registry updated 2023-10-13
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This study is a Phase II single-arm, open label, multicenter study to access the effects and tolerability of fluzoparib combined with apatinib for maintenance treatment in platinum-sensitive relapsed ovarian carcinoma .
Inclusion
- The patient voluntarily joined the study and signed the informed consent.
- Age 18-75 years old.
- Participant has histologically confirmed diagnosis of high-grade predominantly serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer; Or moderately or poorly differentiated ovarian endometrioid adenocarcinoma.
- Previously, after undergoing 2-3 lines of platinum containing chemotherapy, CR or PR was achieved, and the time from the penultimate platinum containing chemotherapy to PD was ≥ 6 months.
- Patients who have received previous treatment with bevacizumab are acceptable.
- Allow previous treatment with PARP inhibitors other than Fluzoparib.
Exclusion
- Previous (within 5 years) or concurrent with other uncured malignant tumors, except for cured skin basal cell carcinoma, thyroid cancer, cervical carcinoma in situ and breast cancer with no recurrence \>3 years after radical surgery.
- The subject has untreated central nervous system metastasis.
- Inability to swallow pills normally, or gastrointestinal dysfunction, which may affect drug absorption according to the researchers.
- Recent (within 3 months) occurrence of intestinal obstruction.
- Patients with clinical symptoms of cancerous ascites and pleural effusion, who need puncture or drainage, or who have received ascites and pleural effusion drainage within 2 months before the first trial medication.
- Patients with poorly controlled cardiac clinical symptoms or diseases, such as: (1) NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, (5) QTc\>470ms.