Actively Recruiting

Phase 2
Age: 18Years - 75Years
FEMALE
NCT05551208

Fluzoparib Combined With Bevacizumab in PSROC Previously Treated With PARPi

Led by Chongqing University Cancer Hospital · Updated on 2022-09-22

42

Participants Needed

1

Research Sites

367 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Fluzoparib Combined With Bevacizumab in PSROC Previously Treated With PARPi

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 75 years with ovarian cancer diagnosed as low/high grade serous carcinoma or endometrioid carcinoma
  • Received 1 to 3 lines of platinum-based chemotherapy after primary cytoreductive surgery
  • At least one measurable lesion by RECIST V1.1 criteria
  • More than 6 months since last chemotherapy cycle to relapse or progression
  • ECOG performance status score of 0 or 1
  • Negative serum or urine pregnancy test within 7 days before enrollment for women of childbearing age and agreement to use contraception during the study
  • Blood counts: hemoglobin 6 g/L, absolute neutrophil count 1.5 x 10^9/L, platelets 100 x 10^9/L
  • Liver enzymes: ALT and AST less than or equal to 3 times upper limit of normal
  • Serum creatinine less than or equal to 1.5 times upper limit of normal
Not Eligible

You will not qualify if you...

  • Use of bevacizumab within 6 months before enrollment
  • Diagnosis of other malignant tumors within 5 years or untreated central nervous system metastases
  • Recent intestinal obstruction or gastrointestinal perforation within 3 months
  • Uncontrolled high blood pressure (systolic 140 mmHg or diastolic 90 mmHg)
  • Moderate to severe cerebrovascular accident, deep vein thrombosis, or pulmonary embolism within 6 months before enrollment
  • Blood clotting disorders
  • History of myocardial infarction, severe arrhythmia, or congestive heart failure NYHA class 2 or higher
  • Active or uncontrolled severe infections

AI-Screening

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Trial Site Locations

Total: 1 location

1

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China, 400030

Actively Recruiting

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Research Team

Z

Zou Dongling, PH.D.

CONTACT

L

Lin Zhong, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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