NCT07033819

Neoadjuvant Treatment of Ovarian Cancer With Fuzuloparib in Combination With Apatinib

A Single-arm, Prospective Clinical Study of Fuzuloparib in Combination With Apatinib for Neoadjuvant Treatment of Homologous Recombination Deficiency Homologous Recombination Deficiency(HRD)-Positive Advanced Ovarian Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study is a single-arm, interventional, open-label, prospective clinical trial. Patients with advanced epithelial ovarian cancer (Federation of International of Gynecologists and Obstetricians，FIGO stage III-IV), who are not eligible for R0 resection or unable to tolerate surgery based on radiological assessment (Suidan score) or laparoscopic assessment (Fagotti score), and who are Homologous recombination deficiency （HRD）positive, will receive neoadjuvant therapy with fuzuloparib and apatinib for two cycles (28 days per cycle). After neoadjuvant treatment, patients who achieve complete or partial response according to radiological assessment will proceed to the surgical treatment phase.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Neoadjuvant therapy with fuzuloparib in combination with apatinib	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.
PROCEDURE	Preoperative Period	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.
DRUG	Chemotherapy	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).
DRUG	Maintenance treatment	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.

Timeline

• Start date: 2025-06-25
• Primary completion: 2027-06-20
• Completion: 2028-06-01
• First posted: 2025-06-24
• Last updated: 2026-02-27

Locations

1 site across 1 country: China