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Fluzoparib Combined With Apatinib for Maintenance Treatment in Platinum-Sensitive Relapsed Ovarian Carcinoma: A Phase II Single-arm, Open Label, Multicenter Trial

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What is being tested

Fluzoparib

+ Apatinib

Drug
Who is being recruted

Urogenital Diseases+12

+ Genital Diseases

+ Adnexal Diseases

From 18 to 75 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2023
See protocol details

Summary

Principal SponsorJin Li
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 30, 2023

Actual date on which the first participant was enrolled.

This clinical trial focuses on finding out how effective and tolerable the combination of two drugs, fluzoparib and apatinib, is for women who have ovarian cancer that has returned after initially responding well to platinum-based chemotherapy. This type of ovarian cancer is called platinum-sensitive relapsed ovarian carcinoma. The study aims to see if this drug combination can help maintain the positive effects of previous treatments for these patients. Understanding how well these drugs work together and their safety can provide better long-term treatment options for managing this type of cancer. Participants in this study will receive fluzoparib and apatinib as a maintenance treatment, meaning these drugs are used to keep the cancer from returning or worsening after initial treatment success. The study will observe how the patients respond to the drugs and monitor any side effects they may experience. By watching how the cancer progresses and how the patients tolerate the medication, researchers hope to gather important data on the benefits and risks of this new treatment combination.

Official TitleFluzoparib Combined With Apatinib for Maintenance Treatment in Platinum-Sensitive Relapsed Ovarian Carcinoma: A Phase II Single-arm, Open Label, Multicenter Trial
NCT06081595
Principal SponsorJin Li
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

54 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by SiteOvarian DiseasesOvarian NeoplasmsUrogenital NeoplasmsFemale Urogenital Diseases

Criteria

9 inclusion criteria required to participate
The patient voluntarily joined the study and signed the informed consent.
Age 18-75 years old.
Participant has histologically confirmed diagnosis of high-grade predominantly serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer; Or moderately or poorly differentiated ovarian endometrioid adenocarcinoma.
Previously, after undergoing 2-3 lines of platinum containing chemotherapy, CR or PR was achieved, and the time from the penultimate platinum containing chemotherapy to PD was ≥ 6 months.
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14 exclusion criteria prevent from participating
Previous (within 5 years) or concurrent with other uncured malignant tumors, except for cured skin basal cell carcinoma, thyroid cancer, cervical carcinoma in situ and breast cancer with no recurrence >3 years after radical surgery.
The subject has untreated central nervous system metastasis.
Inability to swallow pills normally, or gastrointestinal dysfunction, which may affect drug absorption according to the researchers.
Recent (within 3 months) occurrence of intestinal obstruction.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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