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:

• People who are willing to participate and attend follow-up visits
• Adults aged 18 or older, of any gender
• People diagnosed with locally advanced squamous cell cancer of the oesophagus, confirmed by tissue biopsy, at a specific stage of disease (cT1N2-3M0, cT2-4bN0-3M0, or cT1-4bN0-3M1 with spread to lymph nodes above the collarbone, as classified by the 8th AJCC staging system) (confirm with trial site)
• People whose cancer is classed as stage II to IVb and cannot be treated with surgery — either because it cannot be removed, because surgery is medically unsuitable, or because the person has declined surgery
• People who are in good general health and able to carry out normal daily activities with little or no limitation (ECOG score of 0 or 1) (confirm with trial site)
• People whose cancer can be measured or assessed on scans according to standard criteria
• People who have not previously received any treatment for this cancer, including chemotherapy, radiotherapy, immunotherapy, targeted therapy, or any experimental treatments
• People who can provide a tumour tissue sample — either a recent sample (taken within the last 6 months) or a stored sample — for laboratory testing
• People with an expected survival of at least 3 months
• People whose blood counts meet certain minimum levels — including white blood cells, platelets, and haemoglobin — as confirmed by blood tests
• People whose kidneys are functioning adequately, as confirmed by blood tests
• People whose liver is functioning adequately, as confirmed by blood tests
• People whose blood clotting is within an acceptable range, as confirmed by blood tests
• Women who could become pregnant must have a negative pregnancy test within 3 days before starting the trial treatment
• People who have given written informed consent to participate

Who may not be able to join:

• People who have had surgery for oesophageal cancer
• People who have a hole or tunnel (fistula) in the oesophagus caused by the tumour
• People who are at risk of bleeding in the digestive tract, or of developing a hole or tear in the oesophagus
• People in poor nutritional health who have lost 10% or more of their body weight in the past 2 months and have not improved with nutritional support
• People who have had major surgery or a serious injury within 4 weeks before starting the trial
• People with uncontrolled fluid build-up around the lungs, heart, or in the abdomen that requires repeated draining
• People who have previously received immunotherapy (anti-PD-1 or anti-PD-L1), chemotherapy, radiotherapy, or targeted therapy for any condition
• People who have taken part in another clinical trial or used an experimental device within 4 weeks before starting the trial
• People who have needed regular, high-dose steroid tablets or other immune-suppressing medicines in the 2 weeks before starting the trial (certain exceptions may apply — confirm with trial site)
• People who have received an anti-cancer vaccine or a live vaccine within 4 weeks before starting the trial
• People who have an active autoimmune disease or a history of certain autoimmune conditions (such as lung inflammation, eye inflammation, bowel inflammation, liver inflammation, thyroid or pituitary problems, heart or kidney inflammation, or blood vessel inflammation); some exceptions may apply, such as people with stable, well-managed thyroid conditions or type 1 diabetes — confirm with trial site
• People with a known immune deficiency condition, including a positive HIV test, other immune deficiency diseases, or those who have had an organ transplant or bone marrow transplant
• People with serious or poorly controlled heart conditions, including significant heart failure, unstable chest pain (angina), a heart attack within the past year, or certain heart rhythm problems requiring treatment
• People who have had a severe infection requiring hospitalisation within 4 weeks before starting the trial, or who have signs of an active infection requiring antibiotic treatment within 2 weeks before starting the trial
• People with a history of scarring or inflammation of the lung tissue (interstitial lung disease), non-infectious pneumonia, or significantly reduced lung function
• People with active tuberculosis, or a history of tuberculosis within the past year, or older tuberculosis that was not properly treated
• People with active hepatitis B or hepatitis C infection, as confirmed by blood tests
• People with significantly abnormal sodium, potassium, or calcium levels in blood tests taken within 2 weeks before joining the trial, that have not improved with treatment
• People with a known allergy or serious reaction to the study drugs (nab-paclitaxel or carboplatin) or any of their ingredients, or to large protein-based medicines
• People who are pregnant or breastfeeding

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