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A Study of Fluzoparib Combined With QL1101 Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy | Clinical Trials | Clareo Health

UNKNOWNPHASE2

A Study of Fluzoparib Combined With QL1101 Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

A Prospective, Single-Arm, Single-Center, Phase II Clinical Trial Evaluating the Efficacy and Safety of Fluzoparib Combined With QL1101 for Maintenance Treatment in Patients With Advanced Epithelial Ovarian Cancer Following Response After First-line Platinum-containing Chemotherapy

NCT05585281•Yongpeng Wang

View on ClinicalTrials.gov

Summary

This is a Prospective,Single-Center, Single-Arm, Phase 2 study to evaluate the efficacy and safety of Fluzoparib Combined With QL1101, as maintenance treatment, in patients with Advanced FIGO Stage III or IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or primary peritoneal cancer following front-line platinum-based chemotherapy with QL1101. Eligible participants who achieve complete response (CR) or partial response (PR) following treatment with platinum-based chemotherapy in addition to QL1101 will be enrolled in the study and will receive maintenance treatment with fluzoparib (for up to 2 years) combined with QL1101 (for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of the approximately 5 months of bevacizumab received with chemotherapy) or until disease progression, unacceptable toxicity, participant withdrawal, Investigator's decision, or death, whichever comes first.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•I-1.Patients voluntarily participated in this study and signed the informed consent.
•I-2.Age 18-70 years, female. I-3.Eastern Cooperative Oncology Group (ECOG) performance status 0-1. I-4.Patients with newly diagnosed, histologically confirmed, high grade serous or high grade endometrioid ovarian cancer, fallopian-tube cancer, or primary peritoneal cancer（FIGO Stage III or IV）.
•I-5.Completion of ideal tumor cytoreduction (either intermediate cytoreduction or initial cytoreduction).
•I-6.First line therapy with platinum-taxane chemotherapy consists of a minimum of 6 treatment cycles and a maximum of 8 treatment cycles in patients who have achieved complete response (CR) or partial response (PR).
•I-7.Patients who must receive at least 4 cycles of platinum-based therapy if non-hematologic toxicity specifically associated with platinum-based therapy (i.e., neurotoxicity, hypersensitivity reactions, etc.) necessitates early termination.
•I-8.Those who can swallow tablets normally.
•I-9.The functions of vital organs meet the following requirements:
•1. Absolute neutrophil count ≥ 1.5 × 109/L;
•2. Platelets ≥ 90 × 109/L;
•3. Hemoglobin ≥ 100 g/L;
+9 more criteria

Exclusion Criteria

•E-1.Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors).
•E-2.Ovarian tumors of low malignant potential (e.g. borderline tumors), or mucinous carcinoma.
•E-3.Clinical evidence of stable disease or progressive disease following treatment at the end of the first-line chemotherapy.
•E-4.Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS)Patients with a history of localized malignancy diagnosed over 5 years ago, who have completed all treatment and have no recurrent or metastatic disease prior to enrollment may be enrolled.
•E-5.Patients with myelodysplastic syndrome/acute myeloid leukemia history. E-6.Patients receiving radiotherapy within 6 weeks or Major surgery within 4 weeks prior to study treatment.
•E-7.Any previous treatment with PARP inhibitor, including fluzoparib. E-8.Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy.
•E-9.Clinically significant (e.g. active) cardiovascular disease, including:
•1. New York Heart Association (NYHA) grade 2 or higher heart failure.
•2. Unstable angina pectoris.
•3. Myocardial infarction within 1 year.
+7 more criteria

Locations (1)

Yongpeng Wang

Shenyang, China

Key Dates

Start Date

July 27, 2023

Primary Completion Date

November 7, 2025

Completion Date

December 22, 2025

Last Updated

July 28, 2023

Enrollment

ESTIMATED participants

Conditions

Ovarian Cancer

Interventions

Fluzoparib

DRUG

QL1101

BIOLOGICAL

Contacts

Yongpeng Wang

CONTACT

+8613940426817 w18900917191@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Fluzoparib Combined With QL1101 Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

Inclusion Criteria

Exclusion Criteria

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