Phase 2 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:

• Adults aged 18 or older (male or female) who are willing and able to give written consent before any screening takes place.
• People with a confirmed diagnosis of stomach or gastroesophageal junction cancer (a specific type called adenocarcinoma) that has spread or cannot be surgically removed, and where the tumour tests negative for a protein called HER2. People with HER2-positive disease may also be considered if a specific HER2-targeted treatment (trastuzumab) is medically not suitable for them.
• People whose cancer has not yet been treated with chemotherapy or radiotherapy for the advanced or spread stage of the disease. Palliative (symptom-relief) radiotherapy to one area is allowed, provided other untreated areas of disease are still present and measurable.
• People whose cancer can be measured on scans according to a standard set of rules called RECIST 1.1.
• People whose tumour has a specific genetic feature called dMMR (mismatch repair deficiency), confirmed through laboratory testing of tumour tissue.
• People whose primary tumour or a secondary tumour site can be safely biopsied (sampled with a needle or small procedure) more than once.
• People who are reasonably well and able to carry out daily activities, as rated on a standard scale (ECOG performance status 0–2).
• People whose blood counts and organ function (bone marrow, liver, kidneys) meet the minimum levels required by the trial, as confirmed by blood tests.
• Women who could potentially become pregnant must have a negative pregnancy test before starting treatment, and must agree to use adequate contraception during and after treatment as advised by the treating doctor.
• People without significant personal, psychological, or practical circumstances that could make it difficult to follow the trial schedule.

Who may not be able to join:

• People with severely reduced kidney function.
• People who have previously received chemotherapy, biological therapy, or any experimental treatment for their advanced or spread stomach or oesophageal cancer.
• People whose cancer got worse within six months of finishing chemotherapy (containing fluoropyrimidine and/or platinum drugs) given before or after surgery — with one specific exception (confirm with trial site).
• People whose only measurable areas of disease are entirely within a previously treated radiation field and have not shown confirmed progression.
• People with cancer that has spread to the brain, unless it was treated successfully and has been stable for at least three months with no swelling or steroid medication needed.
• People with another active or past cancer (other than the stomach/oesophageal cancer being studied) that could affect their outlook.
• People with a known serious allergy or medical reason preventing the use of the study drugs (retifanlimab, fluoropyrimidines, leucovorin, or oxaliplatin).
• People with a complete inability to process a type of chemotherapy drug due to a specific enzyme deficiency (called complete DPD deficiency).
• People with an active, uncontrolled infection (bacterial, viral, or fungal) requiring ongoing treatment.
• People with a known past or current HIV, hepatitis B, or hepatitis C infection.
• People with signs of a lung condition called interstitial lung disease (ILD).
• People with an active autoimmune disease — though certain well-controlled conditions (such as type 1 diabetes, hypothyroidism on hormone replacement, or mild skin conditions not requiring systemic treatment) may still be considered (confirm with trial site).
• People currently taking part in another clinical trial that could affect this study's results.
• People who are pregnant, breastfeeding, or unwilling to use reliable contraception during treatment and for three months after the last dose.
• People who have taken certain antiviral medications called DPD inhibitors (such as sorivudine or brivudine) within the past four weeks.
• People who already have nerve damage affecting movement or sensation above a mild level (confirm with trial site).
• People who have had an organ transplant or stem cell transplant from a donor.
• People who are taking probiotic supplements at the time treatment would begin.
• People with any other serious uncontrolled medical condition that, in the treating doctor's judgement, would make participation unsafe.

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