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Fluzoparib Combined With Bevacizumab in PSROC Previously Treated With PARPi

ConditionOvarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorChongqing University Cancer Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

The patient had at least one measurable lesion according to the RECIST V1.1 criteria.

The time from the last cycle of chemotherapy to relapse/progression should be more than 6 months.

ECOG score 0~1,age 18~75 years old

Disqualifiers

Had used bevacizumab within 6 months of enrollment

Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated. The patients had untreated CNS metastases.

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.

Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure

Trial design

Design model

Single group

Treatments tested in this trial

  • fluzopanib and bevacizumab

    Drug

    fluzopanib and bevacizumab were used for maintenance treatment

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: maintenance treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PFS

progression-free survival was the maintenance time to progression or recurrence since the last platinum therapy based on RECIST v1.1

Time frame
5 years

Secondary outcomes

1

OS

Overall survival

Time frame
5 years
2

ORR

Objective Response Rate

Time frame
5 years
3

DCR

Disease control rate

Time frame
5 years
4

DoR

Duration of remission

Time frame
5 years

Other outcomes

1

saftey

The severity of adverse events was determined according to CTCAE V5.0 criteria. During the trial, the adverse event record form should be truthfully filled in, including the occurrence time, severity, correlation with study treatment, duration, measures taken and outcome of the adverse event

Time frame
5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chongqing University Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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