Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer

Launched by ANHUI PROVINCIAL HOSPITAL · Aug 3, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the use of two medications, fluzoparib and apatinib mesylate, to see how effective and safe they are for women with advanced ovarian cancer. The main goal of the study is to find out how long patients can live without their cancer getting worse after receiving this treatment. The study will involve women who have been diagnosed with high-grade ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, specifically those in advanced stages (III or IV). To participate, women must not have received previous maintenance therapy with similar medications and must meet certain health criteria.

If you or a loved one qualify and decide to participate, you will receive the study treatment and will be closely monitored for any side effects and how well the treatment is working. The study aims to enroll 51 participants, and you will be required to sign a consent form and attend follow-up visits to check on your health. It’s important to know that this trial is not yet recruiting, so there will be more information available as it begins.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • ECOG PS: 0-1;
• • Initially treated patients with histologically or cytologically confirmed high-grade plasma ovarian cancer (HGSOC), fallopian tube cancer, primary peritoneal cancer, or endometrioid carcinoma of the ovary with FIGO stage III-IV;
• • No prior maintenance therapy with PARP inhibitors; ④Final use of a combination chemotherapy regimen of bevacizumab, paclitaxel and carboplatin; ⑤Good function of major organs; ⑥Subjects voluntarily enrolled in this study, signed an informed consent form, had good compliance, and cooperated with follow-up visits; ⑦The modeled CA-125 ELIMination rate constant K (KELIM) ≥ 1.
• Exclusion Criteria:
• • Patients concurrently enrolled in other clinical trials;
• • Previous maintenance therapy with PARP inhibitors combined with anti-angiogenic drugs;
• • Previous history of allergic reaction, hypersensitivity reaction, intolerance to antibody-based drugs;
• • Previous significant allergy to drugs or food or other substances;
• • Subjects with untreated CNS metastases, previously treated with systemic, radical brain or meningeal metastases (radiotherapy or surgery), may be included if imaging confirms that stabilization has been maintained for at least 1 month and systemic hormone therapy (dose \>10mg/day prednisone or other isotonic hormones) has been discontinued for \>2 weeks without clinical evidence;
• • Those who are unable to swallow tablets normally, or have abnormal gastrointestinal function that, in the judgment of the investigator, may interfere with drug absorption;
• • Have experienced clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months prior to randomization, such as peptic bleeding, bleeding gastric ulcer or suffering from vasculitis, etc. If the fecal occult blood is positive at the baseline period, it can be reviewed, and if it is still positive after review, combined with the clinical judgment, and if necessary, gastroscopy can be performed; ⑧The presence of currently uncontrolled malignant pleural fluid, ascites or pericardial effusion (defined as not effectively controlled by diuretics or puncture, as judged by the investigator);
• • Presence of uncontrolled comorbidities including, but not limited to: active HBV or HCV infection, known HIV infection or history of AIDS, active syphilis, active tuberculosis, active infections, uncontrolled hypertension, symptomatic cardiac insufficiency, and active bleeding;
• • Previous (within 5 years) or concurrent other untreated malignant tumors, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and breast cancer without recurrence \> 3 years after completion of radical surgery; ⑪Women during pregnancy or lactation; ⑫Having taken a drug that clearly affects the study drug within 30 days or 5 half-lives (whichever is longer) prior to enrollment; ⑬In the judgment of the investigator, the subject has other factors that may cause this study to be forcibly terminated midway, such as other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory test abnormalities, accompanied by family or social factors that would affect the subject's safety, or the collection of data and samples.