Fluzoparib+Bevacizumab/Dietary Intervention vs Fluzoparib Monotherapy as First-line Maintenance in HRD+/- Advanced Ovarian Cancer

NCT06954584 | Recruiting Phase 3 DMC

• 1 other identifier: MA-OC-III-013
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 2

Brief Summary

Fluzoparib has been approved for the first-line maintenance treatment of advanced ovarian cancer in the full population . Previous studies have demonstrated that anti-angiogenic agents enhance tumor cell sensitivity to PARP inhibitors . In vitro evidence suggests that low-carbohydrate culture conditions may restore PARP inhibitor sensitivity in HRD-negative tumor cells. This study aims to validate the survival benefits of fluzoparib combined with bevacizumab in HRD-positive ovarian cancer patients during first-line maintenance therapy and explore the efficacy of fluzoparib combined with a dietary intervention in HRD-negative populations.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  The time from randomization to the occurrence of disease progression (as per RECIST v1.1) or death from any cause, whichever occurs first.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 96 months

Secondary Outcomes (5)

• Time to Progression (TTP)

  From date of randomization until the date of first documented CA125 progression (as per GCIG-CA125 criteria) or disease progression (as per RECIST criteria), whichever came first, assessed up to 96 months

• Time to Discontinuation or Death (TDT)

  From date of randomization until the date of first documented discontinuation of study treatment or death from any cause, whichever came first, assessed up to 96 months

• ime to First Subsequent Therapy (TFST)

  From date of randomization until the date of first documented initiation of subsequent anti-tumor therapy for ovarian cancer, or death, assessed up to 96 months

• Best Overall Response (BOR)

  From date of randomization until disease progression or recurrence, assessed up to 96 months

• Overall Survival (OS)

  From date of randomization until the date of death from any cause, assessed up to 96 months

Study Arms (4)

HRD-Positive Cohort (Experimental Group): Fluzoparib + Bevacizumab

EXPERIMENTAL

Fluzoparib Capsules : 150 mg orally twice daily (bid) (50 mg/capsule, 3 capsules/dose) . Bevacizumab : 15 mg/kg intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 15 months .

Drug: Bevacizumab; Drug: Fluzoparib Monotherapy

HRD-Positive Cohort (Control Group): Fluzoparib Monotherapy

ACTIVE COMPARATOR

Fluzoparib Capsules : 150 mg orally bid (50 mg/capsule, 3 capsules/dose)

Drug: Fluzoparib Monotherapy

HRD-Negative Cohort (Experimental Group 1): Fluzoparib + Dietary Intervention

EXPERIMENTAL

Fluzoparib Capsules : 150 mg orally bid (50 mg/capsule, 3 capsules/dose)

Drug: Fluzoparib Monotherapy; Behavioral: Dietary Intervention

HRD-Negative Cohort (Experimental Group 2): Fluzoparib Monotherapy

EXPERIMENTAL

Fluzoparib Capsules : 150 mg orally bid (50 mg/capsule, 3 capsules/dose)

Drug: Fluzoparib Monotherapy

Interventions

Bevacizumab DRUG

Bevacizumab : 15 mg/kg intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 15 months

HRD-Positive Cohort (Experimental Group): Fluzoparib + Bevacizumab

Fluzoparib Monotherapy DRUG

150 mg orally bid (50 mg/capsule, 3 capsules/dose)

HRD-Negative Cohort (Experimental Group 1): Fluzoparib + Dietary Intervention; HRD-Negative Cohort (Experimental Group 2): Fluzoparib Monotherapy; HRD-Positive Cohort (Control Group): Fluzoparib Monotherapy; HRD-Positive Cohort (Experimental Group): Fluzoparib + Bevacizumab

Dietary Intervention BEHAVIORAL

Control carbohydrate intake in the daily diet

HRD-Negative Cohort (Experimental Group 1): Fluzoparib + Dietary Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant voluntarily joins the study, provides written informed consent, demonstrates good compliance, and agrees to follow-up.
• Female, age ≥18 years (calculated on the day of signing the informed consent form).
• Histologically confirmed high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer ; endometrioid adenocarcinoma of the ovary (grade ≥II) :
• For mixed tumors: The high-grade serous or grade ≥II endometrioid component must exceed 50% .
• FIGO 2018 staging as Stage III or IV .
• Documented HRD (Homologous Recombination Deficiency) test results .
• Completed platinum-based chemotherapy with the following requirements:
• Patients unable to tolerate chemotherapy for definitive reasons must complete at least 4 cycles of platinum-based chemotherapy .
• Patients undergoing interval debulking surgery must complete at least 3 cycles of platinum-based chemotherapy post-surgery .
• Prior to randomization, patients must have no evidence of disease (NED) or achieve complete response (CR) or partial response (PR) after first-line platinum-based chemotherapy, with response maintained until study treatment initiation. Randomization and treatment must begin within 8 weeks after the last chemotherapy dose .
• CR definition : No radiologic evidence of disease and CA125 ≤ upper limit of normal (ULN).
• PR definition : ≥30% reduction in tumor size compared to pre-chemotherapy or CA125 reduction ≥90% from baseline (if imaging shows no lesions but CA125 remains above ULN).
• For patients achieving NED after initial debulking surgery:CA125 must decrease to \<1×ULN during treatment and remain \<1×ULN within 7 days prior to randomization; or CA125 reduction ≥90% from baseline and no \>10% increase within 7 days prior to randomization.
• Prohibited during/after platinum-based chemotherapy : Concurrent use of other investigational drugs (except endocrine therapy) or treatments.
• Permitted during chemotherapy : Bevacizumab combination therapy.

You may not qualify if:

• History of other untreated or active malignancies within 5 years (except cured thyroid cancer, basal cell carcinoma, cervical carcinoma in situ, or breast cancer with \>3 years of recurrence-free survival after radical surgery).
• Untreated central nervous system (CNS) metastases :
• Patients with stable CNS metastases (confirmed by imaging for ≥1 month) after prior systemic/local therapy (e.g., surgery/radiotherapy) and off steroids (\>10 mg/day prednisone equivalent) for \>2 weeks may be eligible.
• Prior use of PARP inhibitors (e.g., olaparib, niraparib, rucaparib, pamiparib, fluzoparib).
• Inability to swallow tablets or gastrointestinal dysfunction affecting drug absorption (per investigator judgment).
• Bowel obstruction or gastrointestinal perforation within 3 months prior to randomization.
• Symptomatic malignant ascites/pleural effusion requiring drainage or drainage within 3 months prior to randomization.
• Poorly controlled cardiac disease :
• NYHA Class ≥II heart failure.
• Unstable angina.
• Myocardial infarction within 1 year.
• Clinically significant arrhythmias requiring treatment.
• QTc interval \>470 ms. 8.Coagulation abnormalities :
• INR \>1.5 or PT \>ULN +4 seconds.
• Bleeding tendency or current use of thrombolytics/anticoagulants (low-dose LMWH or aspirin prophylaxis permitted).

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (2)

Tongji Hospital

Wuhan, Hubei, 430000, China

RECRUITING

Tongji Hospital

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab; Diet Therapy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: May 1, 2025
• Study Start: May 27, 2025
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): March 1, 2032
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)