Actively Recruiting
Neoadjuvant Treatment of Ovarian Cancer With Fuzuloparib in Combination With Apatinib
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-02-27
48
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Neoadjuvant Treatment of Ovarian Cancer With Fuzuloparib in Combination With Apatinib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, with FIGO stage III-IV
- Aged between 18 and 70 years
- Histopathological confirmation of high-grade or moderately/lowly differentiated serous carcinoma, endometrioid carcinoma, fallopian tube cancer, or primary peritoneal cancer
- ECOG performance status of 0-1
- Positive for homologous recombination deficiency (HRD) from tissue or blood testing
- At least one measurable lesion assessable by CT or MRI according to RECIST v1.1
- Not eligible for primary debulking surgery due to inability to achieve R0 resection or intolerance to surgery, based on Fagotti laparoscopic score ≥8 or upper abdominal CT score ≥3
- Expected survival greater than 3 months
- Adequate organ function based on laboratory tests within 7 days prior to treatment
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception
- Resolved prior chemotherapy toxicities to ≤ Grade 1 or baseline except stable sensory neuropathy or alopecia ≤ Grade 2
- Voluntary participation with signed informed consent and willingness to comply with follow-up visits
You will not qualify if you...
- Hypersensitivity to the study drug or its ingredients
- Concurrent use of other neoadjuvant therapies during the study
- Unable to swallow oral medications or having gastrointestinal diseases affecting drug absorption
- Prior anti-cancer treatment for ovarian cancer
- Previous treatment with PARP inhibitors or anti-angiogenic agents
- Symptomatic or uncontrolled brain metastases or spinal cord compression
- History of severe venous thromboembolism or pulmonary embolism
- Recent use of other molecular targeted therapies within 4 weeks
- Major surgery within one month before the study start or not recovered from surgery
- History of other malignancies within 3 years except some skin or breast cancers
- Diagnosis of myelodysplastic syndrome or acute myeloid leukemia
- Severe uncontrolled medical conditions or infections including HIV, hepatitis B or C
- Organ transplant recipients except corneal transplantation
- Current participation in other interventional clinical trials or recent use of investigational drugs
- Uncontrolled hypertension despite therapy
- Abnormal blood clotting or bleeding disorders
- Significant proteinuria or urine abnormalities
- History of substance abuse or psychiatric disorders
- Use of strong or moderate CYP3A4 inhibitors or inducers without required washout
- Stroke or transient ischemic attack within past 6 months
- Pregnant, breastfeeding, or planning pregnancy during the study
- Other conditions judged by investigator as unsuitable for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
B
Bin Li Bin Li, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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