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Clinical Trials in China / NCT05551208
Recruiting Phase 2

Fluzoparib Combined With Bevacizumab in PSROC Previously Treated With PARPi

NCT05551208 · tracked via the Priya Life Science China tracker
Sponsor
Chongqing University Cancer Hospital
Phase
Phase 2
Started
2022-08-15
Last updated
2022-09-22

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

fluzopanib and bevacizumab

fluzopanib and bevacizumab: fluzopanib and bevacizumab were used for maintenance treatment

Study summary

There are more and more PARPi(PARP inhibitors) resistance for ovarian cancer patients after previous use of PARP inhibitors. Basic studies have found that there is synergistic effect of bevacizumab combined with PARPi. Therefore we designed the study to include 42 ovarian cancer patients who had PARPi for at least half a year and then relapsed (platinum-sensitive, previously 1-3 lines of chemotherapy). After getting complete remission or partial remission with chemotherapy containing platinum and bevacizumab, fluzopanib and bevacizumab were used for maintenance treatment. The progression-free survival, ORR, DCR, DoR, and safety were evaluated based on RECIST V1.1.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Ovarian cancer patients with histopathological type: low/high grade serous carcinoma, endometrioid carcinoma,had received platinum-based regimens for at least 1-3 lines after primary cytoreductive surgery. 2. The patient had at least one measurable lesion according to the RECIST V1.1 criteria. 3. The time from the last cycle of chemotherapy to relapse/progression should be more than 6 months. 4. ECOG score 0\~1,age 18\~75 years old 5. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial 6. CBC Hb≥90g/L, ANC≥1.5×109/L, PLT≥100×109/L, 7. Serum ALT≤3×UL, AST≤3×ULN#Serum creatinine≤1.5×ULN# Exclusion Criteria: 1. Had used bevacizumab within 6 months of enrollment 2. Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated. The patients had untreated CNS metastases. 3. The patient had Recent intestinal obstruction, gastrointestinal perforation within 3 months, uncontrolled high blood pressure after medication (Systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg), Moderate to severe cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), moderate to severe deep vein thrombosis and moderate to severe pulmonary embolism occurred within 6 months before enrollment. Patient with coagulation dysfunction. 4. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure 5. Activity or uncontrol severe infection

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Chongqing Cancer Hospital Chongqing Chongqing Municipality Recruiting

More Chongqing University Cancer Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05551208 on ClinicalTrials.gov ↗ ← All trials in China