Phase 3 Oesophageal Cancer Trial, Recruiting

Written by an AI model from the 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 consent form agreeing to take part in the study.
• People aged 18 to 75 years old, male or female.
• People whose cancer has been confirmed by a laboratory test (tissue biopsy) to be squamous cell carcinoma of the oesophagus (food pipe).
• People whose cancer is at an advanced or metastatic stage (meaning it has spread) and cannot be treated with the aim of a cure through surgery or combined chemotherapy and radiation. People who have not yet received systemic (whole-body) cancer treatment for their advanced or metastatic disease may be eligible. People who previously had chemotherapy, radiation, or both before or after surgery for earlier-stage disease may also be eligible, as long as it has been more than 24 weeks since their last treatment before the cancer came back.
• People who have at least one tumour that can be measured on scans, according to standard measurement guidelines used by the study team.
• People whose general physical functioning is rated as fully active or restricted only in strenuous physical activity (this is measured on a standard scale used by doctors, called ECOG 0 or 1).
• People whose tumour tissue sample shows a protein called PD-L1 at a level of 1% or above, confirmed through testing before the first dose.
• People whose life expectancy is at least 6 months.
• People whose liver, kidneys, bone marrow, and other organs are functioning well enough at the time of screening.

Who may not be able to join:

• People who have brain metastases (cancer that has spread to the brain) causing symptoms. People with brain metastases that have been treated and are stable, and who have not needed steroid medication for at least 4 weeks before screening, may still be considered (confirm with trial site). People whose cancer has spread to the membranes surrounding the brain or spinal cord are not eligible, regardless of whether that condition is stable.
• People whose tumour has grown into the oesophagus or nearby organs in a way that creates a high risk of serious bleeding or an abnormal opening (fistula) forming between body parts.
• People who have a near-complete blockage of the oesophagus or windpipe confirmed by a camera examination, or who are at risk of a tear or perforation if a stent (a tube used to keep an airway or passage open) were to be placed.
• People who have had certain serious heart or blood vessel problems in the 6 months before signing the consent form, including unstable chest pain (angina), a heart attack, moderate-to-severe heart failure, serious abnormal heart rhythms, stroke or mini-stroke requiring treatment, or blood pressure that remains very high (systolic 160 mmHg or above, or diastolic 100 mmHg or above) despite standard treatment.
• People who have previously received certain types of immunotherapy treatments, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 drugs, or any other drug designed to activate or block immune checkpoint pathways.
• People who have previously received a total dose of the chemotherapy drug cisplatin above 300 mg/m², and whose last dose of cisplatin was within the past 12 months before joining the study.
• People who have received a live vaccine within 4 weeks before the first dose, or who are planned to receive a live vaccine at any point during the study.
• People who have received chemotherapy, targeted therapy, immune-modifying drugs, biological therapies, certain Chinese herbal or patent medicines used as cancer treatments, or any other experimental treatment within the 4 weeks (or five half-lives of the drug, whichever is longer) before the first dose.
• People with other serious medical conditions that the study doctor believes could increase the risks of taking part or make it harder to interpret the study results — for example, severe blood clots in veins or arteries, liver-related brain problems, moderate-to-severe liver scarring (cirrhosis), serious mental illness, or significant abnormalities in blood test results.

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