Phase 3 Oesophageal 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 diagnosed with a specific type of cancer called adenocarcinoma (confirmed by a tissue sample) that is HER2 negative, located in the esophagus, the junction between the esophagus and stomach, or the stomach, and where the PD-L1 CPS score is known before joining (any score is accepted)
• People whose cancer cannot be removed by surgery or has spread to other parts of the body (metastatic)
• People who have measurable or assessable tumors based on standard imaging criteria
• People who have not yet received any treatment specifically for their unresectable or metastatic disease
• People who received chemotherapy or immunotherapy before or after surgery (in an earlier stage of treatment) are still eligible, as long as that treatment finished at least one year before joining the trial
• People aged 18 years or older
• People who are considered fairly well and active, based on a standard medical scale that measures daily functioning (a score of 0 or 1 on the ECOG scale — meaning fully active or able to carry out light activity)
• People whose blood test results meet specific safety thresholds for white blood cell counts, platelet counts, kidney function, liver function, and bilirubin levels (confirm specific numbers with trial site)
• People who have had or currently have another cancer may still be eligible, as long as that cancer and its treatment are unlikely to affect the safety or results of this trial
• People living with HIV may be eligible if they are on effective HIV treatment and have had an undetectable viral load within the 6 months before joining
• People with a history of heart disease or prior treatment with heart-affecting medicines may still be eligible if a doctor's assessment of their heart function rates them at a certain level or better on the New York Heart Association scale (class 2B or better)
• People who will receive the immunotherapy drug nivolumab as part of this trial must not have any reasons that would prevent them from taking immune checkpoint inhibitor medicines, including meeting the specific immune-related conditions listed below
• People must be able to speak, read, and understand one of the following languages to complete a required self-reported questionnaire: English, Spanish, Korean, Simplified Chinese, or Russian

Who may not be able to join:

• People who are pregnant or breastfeeding, as the medicines used in this trial can harm a developing baby; women who could become pregnant will need a negative pregnancy test taken within 7 days before joining
• People with a genetic condition called Gilbert's syndrome, or a specific inherited gene variation called UGAT1A1*28 homozygosity
• People who already have moderate to severe nerve problems affecting sensation or movement (grade 2 or higher peripheral neuropathy), regardless of the cause
• People with serious uncontrolled medical conditions — such as an active infection or poorly controlled diabetes — that the treating doctor believes would make participation too risky
• People with brain metastases (cancer that has spread to the brain) that have not been treated, or that are still causing symptoms; people with previously treated brain metastases may be eligible if follow-up scans at least 4 weeks after brain-directed treatment show no signs of the cancer growing, and they no longer need steroids or have been on a stable steroid dose for more than 4 weeks
• People who have received an organ or tissue transplant from another person (allogeneic transplant)
• People who have an active autoimmune disease that required systemic (whole-body) medical treatment within the 6 months before joining (some exceptions apply — confirm with trial site)
• People who are currently taking strong immune-suppressing medicines, including corticosteroids at doses above a certain level, within 14 days before joining (low-dose or inhaled/topical steroids may be permitted — confirm with trial site)
• People who have had a history of lung inflammation (pneumonitis) not caused by infection that required steroid treatment
• People who previously had to permanently stop immunotherapy due to serious immune-related side effects

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