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NCT05130515
NCT05130515
Who may be able to join
Who might be able to join this trial:
- You understood what the study involves, agreed to take part, and signed a consent form.
- You are a woman between 18 and 70 years old.
- Your cancer has been confirmed by a tissue test (biopsy) to be ovarian clear cell carcinoma (a specific type of ovarian cancer).
- Your cancer came back or got worse during platinum-based chemotherapy after surgery, OR came back or got worse within 6 months of finishing at least 4 rounds of platinum-based chemotherapy.
- Doctors expect you to live for more than 16 weeks.
- You are generally able to carry out daily activities with little or no limitation (confirm with trial site for exact definition).
- Your blood counts, kidney function, and liver function are within acceptable ranges as measured by blood tests.
- You have tested negative for pregnancy and are willing to use reliable contraception during the trial and for 3 months after your last dose, or you abstain from sex, or you are not able to become pregnant.
- You are able to follow the study schedule and requirements.
- Any side effects from previous chemotherapy have mostly cleared up before joining (minor nerve tingling or hair loss up to a moderate level may still be acceptable).
- You have at least one measurable area of cancer that can be tracked on scans.
- It has been at least 4 weeks since your last cancer treatment (or at least 6 weeks if your previous chemotherapy included a drug called mitomycin).
Who may not be able to join:
- You have previously been treated with a type of drug called a PARP inhibitor.
- You are allergic to niraparib or any of its ingredients, or to similar medicines.
- You are allergic to anlotinib or any of its ingredients, or to similar medicines.
- You have active, uncontrolled cancer that has spread to your brain or the lining around your brain (some exceptions may apply — confirm with trial site).
- You had major surgery within the 3 weeks before joining, or you have not fully recovered from surgery.
- You received radiotherapy to more than 20% of your bone marrow within the week before joining.
- You have been diagnosed with another type of cancer within the past 2 years (except for certain fully treated skin cancers).
- You have a specific type of lung cancer involving the central airways, or you are at high risk of coughing up large amounts of blood.
- You have been diagnosed with certain blood or bone marrow disorders (such as MDS or AML — confirm with trial site).
- You have serious or uncontrolled health conditions, such as uncontrolled nausea or vomiting, active HIV, hepatitis B or C, uncontrolled seizures, or a weakened immune system.
- You have had significant bleeding events in the past 3 to 6 months, a history of gastrointestinal bleeding, active bleeding, or you are taking blood-thinning medications such as warfarin, heparin, aspirin (long-term), or clopidogrel.
- You have had a stroke, mini-stroke (TIA), or blood clot in the lungs within the past 6 months.
- You have serious heart problems, such as severe heart failure, a recent heart attack, unstable chest pain, uncontrolled high blood pressure (above 150/100 mmHg), significant heart valve disease, or certain heart rhythm problems.
- You have very low sodium or potassium levels in your blood, or a thyroid condition that cannot be controlled with medication.
- You have received a platelet or red blood cell transfusion within 4 weeks before starting the study drug.
- You are pregnant, breastfeeding, or planning to become pregnant during the trial.
- You have a specific abnormality on your heart tracing (ECG) called a prolonged QTc interval above 450 ms (confirm with trial site if you have a pacemaker).
- You have any other condition, treatment history, or test result that the study doctor believes would make participation unsafe or unsuitable for you.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Trial details
Status
Completed
Phase
Phase 2
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Registry
clinicaltrials_gov
Start date
15 December 2021
Est. completion
1 January 2023
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Objective response rate
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.