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NCT03249142
NCT03249142
Who may be able to join
Who might be able to join this trial:
- You must be a woman aged 18 or older.
- You must be willing and able to sign a consent form and follow the treatment and check-up schedule.
- You must have been recently diagnosed with a specific type of ovarian cancer (epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer), confirmed by a tissue sample (biopsy).
- Your cancer must be at an advanced stage (stage IIIC or stage IV).
- After an assessment procedure (either a keyhole or open surgery review), doctors must have decided that full surgery to remove the tumour upfront is not suitable for you.
- Your treatment plan must involve chemotherapy given before surgery (called neo-adjuvant treatment).
- No more than 8 weeks must have passed between your diagnosis and signing up for the trial.
- You must be in good general health, able to carry out normal daily activities with little or no limitation (confirm with trial site what this means for you specifically).
- If you are 70 years of age or older, you must score below a certain threshold on a geriatric (older adult health) assessment (confirm with trial site).
- Your blood, liver, and kidney function must be at an acceptable level as measured by blood tests.
- If you are taking blood-thinning medication, your blood clotting levels must be within a safe, stable range for at least two weeks before joining.
- If you are being treated in France, you must be enrolled in or be a beneficiary of the French social security system.
Who may not be able to join:
- You have had another type of cancer in the past 5 years, unless it was a certain type of skin cancer, cervical cancer in situ, or a very early-stage breast condition (DCIS) that was fully treated.
- You had major surgery (involving removal of at least one organ, including an ovary) within 28 days before the trial starts.
- You are currently receiving any other chemotherapy, experimental treatment, biological therapy, or hormonal therapy for cancer.
- You have previously been treated with certain types of immunotherapy drugs (such as checkpoint inhibitors or cancer vaccines).
- You have or have had an active autoimmune or inflammatory condition — exceptions include vitiligo, hair loss (alopecia), well-controlled underactive thyroid on medication, or mild psoriasis not needing systemic treatment.
- You have taken immune-suppressing medications (such as steroids like prednisone or certain other drugs) within 14 days before starting the trial, or are likely to need them during the trial.
- You have HIV, active hepatitis B, or active hepatitis C (a past resolved hepatitis B infection may be acceptable — confirm with trial site).
- You have poorly controlled diabetes or poorly controlled underactive thyroid.
- You have recently taken (within 4 weeks) immune-stimulating drugs such as interferon or interleukin-2.
- You have a history of certain serious lung conditions, such as pulmonary fibrosis or drug-induced lung inflammation.
- You have had signs or symptoms of an infection within 2 weeks before starting treatment.
- You have received a live vaccine (such as a live flu vaccine) within 4 weeks before starting the trial, or expect to need one during the trial.
- You regularly take high-dose aspirin (more than 325 mg per day) and have been doing so within 10 days before joining.
- You have a history of a severe high blood pressure emergency or high blood pressure affecting the brain.
- Your blood pressure is not well controlled, even with medication (above 150/100 mmHg).
- You have significant heart problems, such as a heart attack or unstable chest pain within the last 6 months, moderate-to-severe heart failure, poorly controlled heart rhythm problems, or serious problems with blood flow in the limbs.
- You have had a stroke, mini-stroke (TIA), or brain bleed within the last 6 months.
- You have had a bleeding disorder within the last 6 months.
- You have or are suspected to have a condition that causes abnormal bleeding or blood clotting.
- You have or are suspected to have cancer that has spread to the brain or spine, unless it has been treated, is stable, and you have not needed steroids or anti-seizure medication for at least 1 month.
- You have an uncontrolled nervous
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
ARCAGY/ GINECO GROUP
Registry
clinicaltrials_gov
Start date
18 October 2017
Est. completion
31 December 2024
Where this trial is recruiting
🇫🇷 France
Primary endpoints
Toxicity after neo-adjuvant treatment
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.