Phase 2 Ovarian Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Women between the ages of 18 and 70 who are able to understand and sign a consent form before any study procedures begin.
• People who are generally well enough to carry out light activity or desk work (a doctor will assess this using a standard fitness scale scored 0 or 1).
• People with a life expectancy of at least 3 months.
• People who have been diagnosed with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has come back after standard platinum-based chemotherapy — either returning 6 months or more after finishing that treatment, or returning sooner than 6 months (or progressing while on a PARP inhibitor maintenance therapy).
• People who have at least one tumour that can be measured on a scan, according to standard medical measurement rules.
• People who have tumour tissue available — either stored from a previous biopsy or from a new biopsy — for laboratory testing.
• People whose blood counts and organ function (including liver, kidneys, and blood cells) meet the required levels at the screening stage (the trial site will assess this with blood tests).
• Women who could potentially become pregnant must have a negative blood pregnancy test within 3 days before the first dose, and must use a reliable form of contraception from screening until 6 months after the last dose (rhythm or withdrawal methods are not accepted).

Who may not be able to join:

• People whose ovarian cancer is a non-epithelial type, such as carcinosarcoma or sex-cord stromal tumours.
• People who have cancer that has spread to the brain or the lining of the brain.
• People who have fluid build-up in the chest, around the heart, or in the abdomen that requires draining more than once a month.
• People who have had another active cancer within the past 3 years, except for certain easily treated skin cancers or early-stage cancers considered fully cured.
• People who have received certain cancer treatments recently — including chemotherapy, bevacizumab, targeted therapies, or PARP inhibitors within the past 3 weeks; radiotherapy or certain immune-boosting drugs within the past 2 weeks; or hormonal therapy within the past week.
• People who have previously been treated with immune checkpoint inhibitor drugs (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapies) or certain other immune-stimulating drugs.
• People who have had major surgery, an open biopsy, or a serious injury within the past 4 weeks, or who have planned major surgery during the study.
• People with an active autoimmune disease or one that is likely to return — with some exceptions such as certain stable thyroid or skin conditions (confirm with trial site).
• People who have taken steroid medicines (such as prednisone) at doses above 10 mg per day, or other immune-suppressing medicines, within the past 14 days (inhaled or topical steroids at low doses may be allowed).
• People who have received a live vaccine within the past 4 weeks.
• People with a primary or secondary immune deficiency, or those who test positive for HIV.
• People who have previously had an organ transplant or a bone marrow transplant from a donor.
• People with a history of scarring or inflammation of the lungs (interstitial lung disease or non-infectious pneumonitis).
• People who have had a severe infection requiring hospitalisation, blood poisoning (sepsis), or severe pneumonia within the past 4 weeks.
• People with a current active infection that requires treatment, including active tuberculosis or active syphilis, or who have taken antibiotics, antiviral, or antifungal medicines within the past 2 weeks (ongoing hepatitis B suppression therapy may be an exception — confirm with trial site).
• People with active hepatitis B (with virus levels above a specific threshold) or active hepatitis C. People with low-level or inactive hepatitis B, or hepatitis C that has been fully cleared, may still be considered (confirm with trial site).
• People with inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), active diverticulitis, bowel obstruction, or who need feeding or fluids through a tube or drip.
• People with serious heart or blood vessel conditions, including a heart attack, unstable chest pain, blood clots in the lungs, stroke, or deep vein thrombosis within the past 6 months; significant heart failure; certain serious heart rhythm problems; a reduced heart pumping function; a history of heart muscle inflammation; or blood pressure that cannot be controlled.
• People with moderate to severe nerve damage in the hands or feet (grade 2 or above on a standard medical scale).
• People who still have significant side effects from previous cancer treatment (other than hair loss) that have not resolved.
• People with a known severe allergic reaction to any monoclonal antibody medicines.
• People who are pregnant or breastfeeding.
• People with a known allergy to any of the study drugs or their ingredients.
• People who have had a bowel perforation, an abscess inside the abdomen, or a bowel obstruction within the past 3 months, or who currently show signs of bowel obstruction.
• People with blood pressure that remains too high despite medication (systolic at or above 140 mmHg or diastolic at or above 90 mmHg).
• People with blood clotting problems, a tendency to bleed excessively, or who are on blood-thinning medicines (low-dose aspirin or low-dose preventative blood clot injections may be allowed — confirm with trial site).
• People who have had a significant bleeding episode within the past 3 months, such as gastrointestinal bleeding.
• People who have had an arterial or venous blood clot (including stroke, mini-stroke, brain bleed, deep vein thrombosis, or pulmonary embolism) within the past 6 months.
• People with an inherited or acquired bleeding or clotting disorder, such as haemophilia.
• People with an active stomach or skin ulcer, a wound that is not healing, or an unhealed bone fracture.
• People with a significant level of protein in their urine, confirmed by a 24-hour urine test showing more than 1.0 g of protein.
• People who have had radiotherapy covering more than 5% of the bone marrow within the past 4 weeks.
• People who have taken certain medicines that strongly affect how the body processes drugs (strong CYP3A4 inducers within 2 weeks, or strong CYP3A4 inhibitors within 1 week — confirm with trial site which medicines are included).
• People who have previously been treated with anlotinib or similar small-molecule targeted therapy drugs.
• People whose overall health condition, in the treating doctor's judgement, could make participation unsafe or affect the reliability of the study results.

Important: Always verify eligibility with the trial site directly before applying.