Clinical trial NCT05551208: Fluzoparib Combined With Bevacizumab in PSROC Previously Treated With PARPi
Official title: A Prospective, Single-arm, Multicenter Phase Ⅱ Clinical Study of Fluzoparib Combined With Bevacizumab in Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With PARPi
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: PARP inhibitor
Fluzoparib
Bevacizumab
Platinum - sensitive recurrent EOC
Lead sponsor: Chongqing University Cancer Hospital
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: PFS
timeFrame: 5 years
Secondary outcomes:
measure: OS
timeFrame: 5 years
measure: ORR
timeFrame: 5 years
measure: DCR
timeFrame: 5 years
measure: DoR
timeFrame: 5 years
Other outcomes:
measure: saftey
timeFrame: 5 years
Locations:
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
Study officials:
affiliation: Chongqing University Cancer Hospital
name: Zou Dongling, M.D.
role: PRINCIPAL_INVESTIGATOR
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