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Trial Title:
Fluzoparib Combined With Bevacizumab in PSROC Previously Treated With PARPi
NCT ID:
NCT05551208
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Bevacizumab
Conditions: Keywords:
PARP inhibitor
Fluzoparib
Bevacizumab
Platinum - sensitive recurrent EOC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
fluzopanib and bevacizumab
Description:
fluzopanib and bevacizumab were used for maintenance treatment
Arm group label:
maintenance treatment
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.
Detailed description:
Genetic testing of tissue samples before and after the maintenance therapy were also used
to further explore the pattern of gene mutations and the subgroups who may benefit.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chongqing Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Contact:
Last name:
Zou Dongling, PH.D.
Phone:
+8613657690699
Email:
cqzl_zdl@163.com
Contact backup:
Last name:
Lin Zhong, M.D.
Phone:
18623393866
Email:
zhonglin1983.12.25@126.com
Start date:
August 15, 2022
Completion date:
August 30, 2029
Lead sponsor:
Agency:
Chongqing University Cancer Hospital
Agency class:
Other
Source:
Chongqing University Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05551208
