Phase 2 Cervical 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 have given written agreement to take part, or whose immediate family member has done so on their behalf if they are unable to.
• Women aged 18 to 70 years old at the time of signing the consent form.
• People with a laboratory-confirmed diagnosis of cervical cancer that is squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, has not been previously treated with any anti-cancer therapy, and is classified as FIGO 2018 stage IB3, IIA2, or stage IIICr without involvement of the lower third of the vagina and without spread into the tissue alongside the cervix.
• People who have at least one tumour that can be measured by CT or MRI scan according to standard measurement guidelines (RECIST 1.1).
• People who can provide either a stored tumour tissue sample taken within the last 5 years, or a freshly obtained tissue sample (a minimum number of prepared slides is required, with preference for a recent sample).
• People whose general physical health and ability to carry out daily activities is rated at 0 or 1 on a standard medical scale (meaning fully active or restricted in strenuous activity only).
• People with a life expectancy of at least 12 weeks.
• People whose blood, liver, kidney, heart, and urine test results meet specific minimum standards when tested within 14 days before being assigned to a treatment group, without the use of blood transfusions or certain boosting medications during that period (confirm with trial site for exact values).
• Women who are able to become pregnant must use a highly effective form of contraception from the time of signing the consent form until 180 days after the last dose of the study treatment, and must not be pregnant or breastfeeding at the time of joining.

Who may not be able to join:

• People who have previously received any form of immunotherapy, including immune checkpoint drugs (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 treatments) or cell-based immune treatments.
• People who have had a serious infection requiring intravenous antibiotics for more than 7 days within the 2 weeks before joining, or who have had an unexplained fever above 38.5°C during screening or in the 2 weeks before joining (unless the fever is considered by the doctor to be caused by the tumour).
• People who have taken high-dose steroid tablets or other immune-suppressing medications within the 2 weeks before joining (topical, nasal, or inhaled steroids are generally allowed; confirm with trial site).
• People who have taken certain immune-boosting treatments such as thymosin, lentinan, interferon, or interleukins within the 2 weeks before joining.
• People who have taken high-dose aspirin, certain blood-thinning or anti-clotting medications within the 2 weeks before joining (low-molecular-weight heparin may be permitted; confirm with trial site).
• People who have used certain Chinese herbal medicines approved for anti-cancer treatment within the 2 weeks before joining.
• People who have had major surgery, an open biopsy, or a serious injury within 4 weeks before joining, or who have planned major surgery scheduled during the study period.
• People who have received any anti-cancer treatment such as chemotherapy, targeted therapy, or biological therapy within the 4 weeks before joining.
• People who have active, symptomatic cancer spread to the brain or spinal cord at the time of joining (people with stable, non-symptomatic brain involvement who have completed treatment and are off certain medications for at least 2 weeks may be considered; confirm with trial site).
• People with a significant kidney blockage that cannot be relieved by a medical procedure.
• People with recurring fluid build-up in the chest or abdomen that requires repeated draining and is considered poorly controlled.
• People with an active or potentially returning autoimmune disease, with some exceptions such as stable thyroid condition on hormone replacement, type 1 diabetes on stable insulin, or certain skin conditions not requiring systemic treatment (confirm with trial site).
• People who have had a perforation or abnormal opening in the digestive or urinary tract, or an abdominal abscess, within the 6 months before joining (unless the problem has been surgically repaired).
• People who have had a bowel blockage within the 6 months before joining, or who have active inflammation in the digestive tract such as peptic ulcer, diverticulitis, or colitis.
• People with significant heart or blood vessel problems, including a heart attack, unstable chest pain, blood clot in the lungs, stroke, or similar events within the past 6 months; severe heart failure; serious heart rhythm problems requiring medication; or an abnormal heart electrical reading on a specific test at screening.
• People with poorly controlled high blood pressure despite treatment, a history of severe blood pressure crisis, bleeding in the brain or spine, serious blood clotting problems, coughing up significant amounts of blood, certain radiation-related bowel or bladder complications with bleeding within 3 months before joining, signs of free air in the abdomen, serious unhealed wounds or untreated broken bones, or any other condition the doctor considers to carry unacceptable risk.
• People with significant lung conditions such as interstitial lung disease or severely reduced lung function that could make it difficult to detect or manage potential lung side effects from the study treatment.
• People who are HIV-positive, or who have active hepatitis B or active hepatitis C infection (as defined by specific test results; confirm with trial site).
• People with known active tuberculosis or active syphilis.
• People who have had another cancer within the past 5 years, with some exceptions for certain localised skin cancers or other adequately treated early cancers (confirm with trial site).
• People who have previously had a stem cell or organ transplant (corneal transplant is generally permitted).
• People who have received a live vaccine within the 4 weeks before joining.
• People who are currently taking part in another clinical trial or who have received an experimental treatment within the 4 weeks before joining.
• People with a history of substance misuse or a psychiatric or neurological condition that could affect their ability to follow the study requirements.
• People with a known allergy or sensitivity to the study drugs (QL1706, cisplatin, carboplatin, or paclitaxel) or to similar types of medications.
• People who have any other condition that, in the treating doctor's judgement, could increase the risks of being in the study or affect the results.

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