Neoadjuvant Treatment of Ovarian Cancer With Fuzuloparib in Combination With Apatinib

NCT07033819 | Recruiting Phase 2

• 1 other identifier: 24/463-4743
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer

Keywords

ovarian cancer; neoadjuvant therapy; targeted therapy

Outcome Measures

Primary Outcomes (1)

• R0 Resection Rate

  Proportion of patients with advanced epithelial ovarian cancer who are not R0 resectable at first diagnosis or who cannot tolerate surgery who undergo tumour cytoreduction to achieve R0 resection.

  4 months

Secondary Outcomes (4)

• Objective Remission Rate (ORR)

  24 months

• Progression-Free Survival (PFS)

  24 months

• Disease Control Rate (DCR)

  24 months

• Overall Survival (OS)

  36 months

Study Arms (1)

neoadjuvant therapy

EXPERIMENTAL

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

Drug: Neoadjuvant therapy with fuzuloparib in combination with apatinib; Procedure: Preoperative Period; Drug: Chemotherapy; Drug: Maintenance treatment

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.

Also known as: Neoadjuvant therapy

neoadjuvant therapy

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.

neoadjuvant therapy

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).

neoadjuvant therapy

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.

neoadjuvant therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, with FIGO stage III-IV.
• Age between 18 and 70 years.
• Histopathological confirmation via laparoscopic biopsy or core needle biopsy indicating high-grade (or moderately/lowly differentiated) serous carcinoma, endometrioid carcinoma, fallopian tube cancer, or primary peritoneal cancer.
• Eastern Cooperative oncology Group (ECOG) performance status of 0-1.
• Positive for homologous recombination deficiency (HRD) based on tissue or blood sample testing.
• Presence of at least one measurable lesion assessable by CT or MRI (RECIST v1.1).
• Ineligibility for primary debulking surgery due to inability to achieve R0 resection or intolerance to surgery, based on: Fagotti laparoscopic score ≥8. Upper abdominal CT score ≥3 when laparoscopic assessment is not feasible. Judgment criteria for surgery intolerance: BMI ≥40.0. Multiple chronic diseases. Malnutrition or hypoalbuminemia. Moderate to large volume ascites. Newly diagnosed venous thromboembolism.
• ECOG performance status \>2.
• Expected survival of \>3 months.
• Adequate organ function, with laboratory results meeting the following criteria within 7 days prior to treatment initiation:
• Hematological tests (no transfusions or hematopoietic growth factor use within 7 days prior to screening): Hemoglobin (Hb) ≥90 g/L. Absolute neutrophil count (ANC) ≥1.5×10⁹/L. Absolute lymphocyte count (LC) ≥0.5×10⁹/L. Platelet count (PLT) ≥100×10⁹/L. White blood cell count (WBC) ≥3.0×10⁹/L and ≤15×10⁹/L. Biochemical tests (no transfusions or albumin use within 7 days prior to screening): Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. Alkaline phosphatase (ALP) ≤2.5×ULN. Total bilirubin (TBIL) ≤1.5×ULN.
• Serum creatinine (Cr) ≤1.5×ULN, with creatinine clearance (CrCL) ≥60 mL/min (Cockcroft-Gault formula). Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN, with international normalized ratio (INR) ≤1.5×ULN (not receiving anticoagulant therapy).
• Urinalysis: Urine protein \<2+; if urine protein ≥2+, then 24-hour urine protein quantification must show protein ≤1 g. 12-lead electrocardiogram (ECG): Fridericia-corrected QT interval (QTcF) \<470 ms for females.
• Women of childbearing potential must have a negative serum or urine pregnancy test within one week prior to enrollment and must agree to use effective contraception during the study.
• Any prior chemotherapy-related toxicities must have resolved to ≤CTCAE Grade 1 or baseline, except for stable sensory neuropathy or alopecia of ≤CTCAE Grade 2.

You may not qualify if:

• Hypersensitivity to the investigational drug or its excipients.
• Concurrent use of other neoadjuvant therapies for tumors during the study, including but not limited to chemotherapy, radiotherapy, immunotherapy, microbiological therapy, traditional Chinese medicine, or other experimental therapies.
• Inability to swallow oral medications, or presence of gastrointestinal diseases that may interfere with the absorption or metabolism of the study drug, such as uncontrollable nausea and vomiting, gastrointestinal obstruction, or malabsorption.
• Prior anti-cancer treatment for ovarian cancer.
• Previous treatment with known or potential PARP inhibitors or anti-angiogenic agents.
• Symptomatic or uncontrolled brain metastases requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids, or clinical manifestations of spinal cord compression.
• History of severe venous thromboembolism or pulmonary embolism.
• Receipt of other molecularly targeted therapies within 4 weeks prior to enrollment.
• Major surgery within one month prior to the start of the study, or not yet recovered from surgery.
• History of other malignancies within the past 3 years, except for adequately treated squamous cell carcinoma of the skin, basal cell carcinoma, ductal carcinoma in situ of the breast, or cervical carcinoma in situ.
• Prior or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
• Severe, uncontrolled medical conditions or investigator judgment that the participant is not suitable for the study, including but not limited to: active viral infections such as human immunodeficiency virus (HIV), hepatitis B, hepatitis C; severe cardiovascular disease, uncontrolled ventricular arrhythmias, myocardial infarction within the past 3 months; uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, or other psychiatric disorders affecting the ability to provide informed consent; uncontrolled hypertension; immunodeficiency (except splenectomy) or other diseases that the investigator deems may expose the patient to high-risk toxicity.
• Infection with human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis B, hepatitis C (positive for HCV antibody and HCV-RNA above the lower limit of detection of the assay), or co-infection with hepatitis B and C.
• Receipt of solid organ or hematopoietic stem cell transplantation during the study period (except for corneal transplantation).
• Current participation in another interventional clinical study, or receipt of other investigational drugs or devices within 4 weeks prior to the first dose; not fully recovered from toxicities and/or complications of any prior interventions (i.e., ≤Grade 1 or returned to baseline, excluding fatigue or alopecia).

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Neoadjuvant Therapy; apatinib; Preoperative Period; Drug Therapy; Opiate Substitution Treatment

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)

Combined Modality Therapy; Therapeutics; Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Bin Li Bin Li, PhD

CONTACT

86+13801364117; libin@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: June 24, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)