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NCT Number: NCT05551208

Fluzoparib Combined With Bevacizumab in PSROC Previously Treated With PARPi

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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
  • CBC Hb≥90g/L, ANC≥1.5×109/L, PLT≥100×109/L,
  • Serum ALT≤3×UL, AST≤3×ULN#Serum creatinine≤1.5×ULN#

Exclusion criteria

  • 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
  • Activity or uncontrol severe infection

Treatment and study plan

fluzopanib and bevacizumab

Drug

fluzopanib and bevacizumab were used for maintenance treatment

Primary outcomes

  1. PFS

    Time frame: 5 years

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

Secondary outcomes

  1. OS

    Time frame: 5 years

    Overall survival

  2. ORR

    Time frame: 5 years

    Objective Response Rate

  3. DCR

    Time frame: 5 years

    Disease control rate

  4. DoR

    Time frame: 5 years

    Duration of remission

Other outcomes

  1. saftey

    Time frame: 5 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Zhong, M.D.

CONTACT

[email protected]

18623393866

Zou Dongling, PH.D.

CONTACT

[email protected]

+8613657690699

Sponsors and collaborators

Lead sponsor

Chongqing University Cancer Hospital

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2029
First posted
Sep 22, 2022
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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