ovarian cancer
Conditions
Interventions
Experimental group:Fluzoparil alone or in combination with Apatinib
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily join the study, agree to the treatment according to the study protocol, sign the informed consent, comply well, and cooperate with the follow-up; 2. Women aged 18-70 years; 3. ECOG PS: 0-2 points; 4. Ovarian epithelial carcinoma, tubal carcinoma or primary peritoneal carcinoma confirmed by histology or pathology; 5. FIGO stage II-IV; 6. Previous chemotherapy treatment; 7. Patients who were determined to receive fluzoparil monotherapy or fluzoparil combined with Apatinib; 8. Expected survival >=3 months; 9. Patients of childbearing age must have undergone a pregnancy test (serum or urine) within 7 days prior to inclusion, with a negative result, and be willing to use an appropriate method of contraception during the test period and 8 weeks after the last dose of the test drug.
Exclusion criteria
Exclusion criteria: 1. Lactating patients; 2. Serious factors affecting oral administration and absorption of drugs; 3. Severe anemia, leukocytes, neutrophils, lymphocytes, platelets seriously decreased; 4. Patients with hypertension and unable to obtain good control after antihypertensive drug treatment, have suffered from serious cardiovascular diseases in the past: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including QTc interval >= 470 ms in women); According to NYHA criteria, patients with grade III to IV cardiac insufficiency or left ventricular ejection fraction (LVEF) 1.5 or PT > ULN+4 seconds or APTT > 1.5ULN), who are receiving thrombolytic or anticoagulant therapy and have bleeding tendency; 6. Past arteriovenous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism, occurred within 6 months prior to study initiation; 7. Patients at risk of active bleeding or gastrointestinal bleeding should not be enrolled, including: (1) Active digestive ulcer lesions with fecal occult blood; (2) Patients with history of black stool and hematemesis within 3 months; (3) Intestinal perforation and intestinal obstruction; 8. Within 30 days after major operation; 9. CYP3A4 strong inhibitor should be used in combination; 10. Severe hepatic and renal insufficiency; 11. Those who have a history of psychotropic substance abuse and cannot abstain or have a history of mental disorders; 12. Other patients deemed unsuitable for inclusion by the investigator. Items 6, 7, 8, 9 and 10 of the above exclusion criteria were mainly used as the criteria for patients combined with Apatinib. Patients with the above conditions of fluzoparil as a single drug could be included in the group according to their physical conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR(Objective response rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS(Progression-free survival);DCR(Disease control rate);DoR(Duration of response);OS(Overall survival);Safety; | — |
Countries
China
Contacts
Public ContactGuo Liyuan
Harbin Medical University Cancer Hospital
Outcome results
None listed