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 who have been diagnosed with advanced or inoperable stomach, gastroesophageal junction, or esophageal cancer (a type called adenocarcinoma) that cannot be surgically removed
• People whose cancer tissue has tested positive for a protein called PD-L1, with a score of 1 or higher, using a tissue sample taken within the past two years
• People whose cancer has been confirmed by laboratory testing to be a specific type: microsatellite stable (MSS) and HER2 negative (confirm with trial site if these terms are unfamiliar)
• People who have recent scan results (CT or MRI) confirming their cancer has spread or cannot be removed, taken within 28 days of joining (or within 42 days for certain cases)
• People who previously had brain metastases (cancer spread to the brain) that were treated, with no signs of the cancer growing back in the brain, and where treatment for the brain was completed at least 28 days before joining
• People whose cancer got worse during, or who could not tolerate, a first round of standard chemotherapy combined with an immunotherapy drug such as nivolumab or pembrolizumab (or a similar drug)
• People who have received only one prior course of treatment for advanced or inoperable disease — being chemotherapy combined with an immunotherapy drug (radiation or regional therapies do not count as a prior line)
• People aged 18 or older
• People who are generally well enough to carry out light activity and self-care, as assessed by a performance score of 0, 1, or 2 on a standard medical scale
• People who have had a full medical check-up and physical examination within 28 days before joining
• People whose recent blood test results meet specific levels for white blood cells, neutrophils, haemoglobin, and platelets (the trial site will check these values)
• People whose liver function test results are within acceptable ranges, as tested within 28 days before joining (a different limit applies for people with a condition called Gilbert's disease or liver metastases)
• People whose kidney function is measured at a creatinine clearance of at least 40 mL/min, based on a blood test within 28 days before joining
• People whose urine protein levels are within acceptable limits on a recent urine test
• People with adequate heart function, assessed as Class 2 or better on a standard heart health scale (for those with a known heart condition or history of heart-related treatment)
• People who have recovered from side effects of any previous cancer treatment to a mild or stable level
• People living with HIV, provided they are on effective treatment and have had an undetectable viral load within the past 6 months
• People with a history of hepatitis B, provided the virus is undetectable while on suppressive treatment, based on results within the past 6 months
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated with an undetectable viral load within the past 6 months
• People who are not pregnant or breastfeeding, and people of reproductive potential who have agreed to use effective contraception during the trial
• People who are willing and able to give informed consent, or whose legally authorised representative can do so on their behalf
• People who are willing to complete quality-of-life questionnaires (available in English or Spanish) if able to do so
• People who are offered the opportunity to have tissue and blood samples stored for future research (consent is part of the process)

Who may not be able to join:

• People who have received more than one prior course of systemic treatment (chemotherapy plus immunotherapy) for advanced or inoperable disease
• People who are currently taking corticosteroid medicines (such as prednisone at doses above 10 mg per day) or other medicines that suppress the immune system, within 14 days before joining — some low-dose or topical forms may be permitted (confirm with trial site)
• People who previously had to permanently stop an immunotherapy drug due to a serious immune-related side effect such as lung inflammation (pneumonitis), heart inflammation (myocarditis), kidney failure, Guillain-Barré syndrome, or myasthenia gravis — hormone-related side effects are generally not excluded
• People who have received a live vaccine within 28 days before joining
• People who have had major surgery within 28 days, or had a port or venous access device placed within 7 days, before joining
• People who have not fully recovered from a recent surgery, or who had bleeding or wound problems after surgery in the past 8 weeks
• People who are planning to have major elective surgery during the trial
• People who have had active bleeding, a hole (perforation) or abnormal connection (fistula) in the digestive tract, or significant gastrointestinal bleeding requiring medical intervention, within 84 days before joining
• People who plan to receive other cancer treatments — such as chemotherapy, immunotherapy, or other investigational drugs — at the same time as trial treatment
• People who have had a severe allergic reaction (Grade 3 or 4) to a humanised or human monoclonal antibody drug in the past
• People who have had severe (Grade 3 or 4) immune-related side effects from prior immunotherapy, apart from hormone-related conditions such as thyroid problems
• People who have had a heart attack, stroke, mini-stroke (TIA), or unstable chest pain (angina) within the 6 months before joining
• People with uncontrolled high blood pressure at the time of joining, as assessed by the treating doctor
• People with a history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) or certain autoimmune conditions (such as lupus, rheumatoid arthritis, scleroderma, or autoimmune nerve/muscle conditions) — people with Graves' disease may still be eligible (confirm with trial site)
• People who have had lung inflammation (pneumonitis) requiring steroid treatment in the past 12 months
• People who have another cancer that, in the treating doctor's opinion, could interfere with the safety or results of this trial
• People who are pregnant or breastfeeding, or people of reproductive potential who are not willing to use effective contraception

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