Phase 2 Endometrial 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:

• People who are willing to sign a written consent form to participate.
• People aged 18 to 45 years old at the time of joining the trial.
• People who are generally well enough to carry out daily activities with little or no limitation (as measured by a standard medical scale called ECOG, scoring 0 or 1).
• People who have been confirmed through a tissue biopsy to have stage IB2 or IB3 cervical cancer of specific types: squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (based on 2018 FIGO staging).
• People whose imaging scans show the cancer has not spread beyond the cervix and has not reached distant parts of the body or nearby lymph nodes.
• People who have not previously received any treatment for cervical cancer, including radiotherapy, chemotherapy, immunotherapy, or targeted therapy.
• People who wish to preserve their ability to have children in the future, and whose doctor has determined there are no medical reasons preventing them from having fertility-preserving surgery.
• People who have at least one measurable area of cancer that has not yet been treated, as assessed by standard imaging guidelines (RECIST v1.1).
• People who agree to provide tumour tissue and blood samples for use in the study during and after the screening period.
• People whose blood counts meet minimum levels: white blood cells (neutrophils) at a sufficient level, platelets at a sufficient level, and haemoglobin at a sufficient level (without having received blood or growth factor support in the 7 days before starting the study).
• People whose kidneys are functioning well enough, based on a calculated measure of kidney filtration rate, and whose urine protein levels are within acceptable limits.
• People whose liver is functioning well enough, based on blood test results for bilirubin, liver enzymes (AST and ALT), and albumin levels.
• People whose blood clotting function is within acceptable limits (or, if taking blood-thinning medication, whose clotting levels are stable and within the expected range for that treatment).
• People whose heart is pumping effectively, with a heart pumping strength (left ventricular ejection fraction) of at least 50%.
• Women who could potentially become pregnant must have a negative pregnancy test within 3 days before starting the study medication, and must use a reliable method of contraception from the screening period until at least 120 days after the last dose (confirm with trial site for approved methods).
• People who are willing and able to attend scheduled visits and follow all study requirements.

Who may not be able to join:

• People whose cervical cancer is of a different tissue type, such as small cell carcinoma or gastric-type adenocarcinoma.
• People who have had another cancer in the past 3 years, though people who have had certain fully treated skin cancers, superficial bladder cancer, or breast cancer may still be considered (confirm with trial site).
• People who are currently enrolled in another clinical trial that involves an active treatment intervention.
• People whose cancer has spread to distant parts of the body or to nearby lymph nodes.
• People who have received certain immune-boosting therapies (such as interleukins, interferons, or thymosin) within 2 weeks before starting the study, or certain herbal or traditional medicines with anti-tumour uses within 1 week before starting.
• People who have an active autoimmune disease that currently requires systemic medical treatment (note: hormone replacement therapies for certain gland conditions are not considered systemic treatment for this purpose).
• People who have a history of non-infectious lung inflammation or lung disease requiring steroid treatment, or who currently have interstitial lung disease.
• People with a history of serious bleeding problems or blood clotting disorders.
• People with currently uncontrolled serious health conditions, such as severe liver disease, kidney disease, uncontrolled metabolic disorders, severe stomach or bowel ulcers, or mental health conditions that would prevent them from safely participating.
• People with a history of heart muscle disease, heart inflammation, or dangerous heart rhythm problems, or who have had serious heart or blood vessel events (such as heart attack, heart failure, or blood vessel surgery) within the past 12 months.
• People who have had serious stomach or bowel problems within the past 6 months, such as internal bleeding, bowel blockage, perforation, or abdominal abscess; or who have had serious blood clot events, stroke, or severely uncontrolled high blood pressure within the past 6 months; or who have had a flare-up of a chronic lung condition (COPD) within the past month; or who currently have high blood pressure that remains above a certain level even while taking blood pressure medication.
• People with active or known inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.
• People who have had a serious infection requiring hospitalisation within the past 4 weeks, or who have been receiving treatment for an active infection within the 10 days before starting the study.
• People who have had major surgery or a serious injury within the past 30 days, or minor local surgery within the past 3 days before starting the study.
• People with a history of immune system deficiency, a positive HIV test, or who are currently taking long-term steroid or immunosuppressant medications.
• People with known active tuberculosis or active syphilis infection.
• People who have previously had an organ transplant or bone marrow/stem cell transplant from a donor.
• People with untreated active hepatitis B or active hepatitis C infection (certain hepatitis B patients receiving antiviral treatment may still be considered — confirm with trial site).
• People who have received a live vaccine within 30 days before starting the study, or who plan to receive one during the study.
• People who are known to be allergic to any component of the study drugs, or who have had a severe allergic reaction to similar antibody-based medicines in the past.
• People with a history of mental illness, or current problems with substance misuse or alcohol dependency.
• Women who are pregnant or currently breastfeeding.
• People with any other past or current condition, treatment history, or abnormal test result that the trial doctors believe could interfere with the study results or may make participation unsafe.

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