Neoadjuvant Treatment of Ovarian Cancer With Fuzuloparib in Combination With Apatinib

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT07033819
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Neoadjuvant therapy with fuzuloparib in combination with apatinib — DRUG
    Neoadjuvant Treatment Period Fuzuloparib: 150 mg, twice daily, orally, either before or after meals. It is recommended to take it within 0.5 hours after breakfast and dinner. Continuous administration for 4 weeks constitutes one cycle, for a total of two cycles. Apatinib: 250 mg, once daily, orally, recommended to be taken within 0.5 hours after breakfast. Continuous administration for 4 weeks constitutes one cycle, for a total of two cycles.
  • Preoperative Period — PROCEDURE
    Discontinue Fuzuloparib 7 days before surgery. Discontinue Apatinib 14 days before surgery. The specific timing will be assessed by the investigator based on postoperative wound healing.
  • Chemotherapy — DRUG
    Postoperative Adjuvant Chemotherapy Period (≥4 cycles) Paclitaxel: 150-175 mg/m², intravenous infusion, every 3 weeks (Q3W). Carboplatin: AUC 4-5, intravenous infusion, every 3 weeks (Q3W).
  • Maintenance treatment — DRUG
    Maintenance Treatment Period Fuzuloparib: 150 mg, twice daily, orally. Continuous administration for 4 weeks constitutes one cycle. Treatment will continue until disease progression, intolerable toxicity, or other reasons as specified in the protocol.

Study Details

In this study, investigators propose to use fuzuloparib and apatinib as neoadjuvant therapy for Homologous recombination deficiency （HRD）positive advanced ovarian cancer patients, aiming to explore the efficacy and safety of this 'de-chemotherapy' regimen as neoadjuvant therapy for advanced ovarian cancer, and to conduct genetically related subgroup analyses, to guide the precision therapy and provide a new therapeutic option for HRD-positive patients with advanced ovarian cancer. To provide a new treatment option In order to increase the R0 resection rate of surgery and reduce chemotherapy resistance, thus improving the prognosis and prolonging the survival of patients.

Key Dates

Start date
Jun 25, 2025
Status verified
Feb 2025
Primary completion
Jun 20, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: neoadjuvant therapy
    Participants will receive neoadjuvant therapy with fuzuloparib and apatinib for a total of two cycles (28 days per cycle).

Primary Outcome Measure

R0 Resection Rate [ Time Frame: 4 months ]

Central Contacts

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