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 take part and attend follow-up visits
• People aged 70 years or older, of any gender
• People who have been confirmed by tissue testing to have locally advanced squamous cell cancer of the oesophagus (food pipe) at specific stages, as classified by medical staging guidelines
• People whose cancer has been assessed by doctors as not suitable for surgery — either because it cannot be removed, surgery is medically inadvisable, or the person has chosen not to have surgery — and whose cancer is at stage II to IVb
• People who are reasonably active and able to carry out daily activities (rated 0 or 1 on a standard medical activity scale)
• People whose cancer can be measured or assessed using standard imaging criteria
• People who have not previously received any cancer treatment, including chemotherapy, radiation, targeted therapy, immunotherapy, or any other anti-cancer treatment
• People who can provide a tumour tissue sample (either a recent or archived sample from within the last 6 months) for laboratory analysis
• People whose doctors expect them to survive for at least 3 months
• People whose blood counts are at adequate levels, including white blood cells, platelets, and haemoglobin
• People whose kidneys are functioning adequately, based on blood test results
• People whose liver is functioning adequately, based on blood test results
• People whose blood clotting function is within acceptable ranges
• People who have given written informed consent to take part

Who may not be able to join:

• People who have already had surgery for oesophageal cancer
• People who have a fistula (an abnormal opening or tunnel) in the oesophagus caused by the tumour
• People who are at risk of bleeding in the digestive tract, or of a hole or abnormal opening forming in the oesophagus
• People who are in poor nutritional health, having lost 10% or more of their body weight in the past 2 months without meaningful improvement after nutritional support
• People who have had major surgery or a serious injury within 4 weeks before starting the study treatment
• People with fluid build-up in the chest, around the heart, or in the abdomen that cannot be controlled and requires repeated draining
• People who have previously received anti-PD-1 or anti-PD-L1 immunotherapy, chemotherapy, radiation, or targeted cancer therapy
• People who have taken part in another clinical trial within 4 weeks before the first study dose
• People who have been taking high-dose steroid or other immune-suppressing medications within 2 weeks before the first study dose (confirm with trial site for specific exceptions)
• People who have received a cancer vaccine or a live vaccine within 4 weeks before the first study dose
• People with an active autoimmune disease, or a history of certain autoimmune conditions (some exceptions may apply — confirm with trial site)
• People diagnosed with an immune deficiency condition, including a positive HIV test, other immune deficiency diseases, or who have had an organ transplant or bone marrow transplant
• People with serious uncontrolled heart conditions, such as significant heart failure, unstable chest pain (angina), a heart attack within the past year, or certain serious heart rhythm problems
• People who have had a severe infection within 4 weeks before starting the study treatment, or signs of active infection requiring antibiotic treatment within 2 weeks before starting (confirm with trial site for specific exceptions)
• People with a history of scarring or inflammation of the lung tissue, or significantly reduced lung function
• People with active tuberculosis, or a history of tuberculosis that was not properly treated
• People with active hepatitis B or hepatitis C infection at levels above specified thresholds
• People with significantly abnormal sodium, potassium, or calcium levels in the blood that have not improved with treatment, within 2 weeks before joining the trial
• People with a known allergy or serious reaction to any of the study drugs or their ingredients, including tirilizumab, paclitaxel, or cisplatin

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