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 or older, of any gender
• People who have been diagnosed with locally advanced squamous cell cancer of the oesophagus (a specific type and stage of oesophageal cancer), confirmed by a tissue biopsy
• People whose cancer can be measured or assessed according to specific medical guidelines (confirm with trial site)
• People who have already received a specific course of combined radiation and chemotherapy treatment (radiation to at least 45 Gy in at least 25 sessions, plus at least one cycle of a chemotherapy drug called S-1), and who had not received any other cancer treatment before that radiation
• People with a good general level of physical functioning, rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity)
• People who can provide a tumour tissue sample — either a recent one or one stored within the past 6 months — for laboratory testing
• People expected to survive at least 3 months
• People whose blood counts, liver function, kidney function, and blood clotting results fall within the ranges required by the trial (confirm with trial site for specific values)
• People who have signed a consent form agreeing to take part

Who may not be able to join:

• People who have had surgery for oesophageal cancer
• People who have developed a hole or abnormal opening (fistula) in the oesophagus caused by the tumour
• People considered to be at risk of bleeding in the digestive tract, or of developing a fistula or perforation of the oesophagus
• People who developed moderate or severe lung inflammation (grade 2 or higher) as a result of their chemoradiotherapy
• People with poor nutritional status who have lost 10% or more of their body weight in the past 2 months, with no meaningful improvement after nutritional support
• People who have had major surgery or a serious injury within 4 weeks before the first dose of the trial treatment
• People with fluid build-up around the lungs, heart, or abdomen that cannot be controlled and requires repeated draining
• People who have previously received immunotherapy targeting PD-1 or PD-L1, chemotherapy, radiotherapy, or targeted cancer therapy (beyond what was part of the required initial treatment described above)
• People who have taken part in another clinical trial within the past 4 weeks
• People who need ongoing high-dose steroid or other immune-suppressing medication (with some exceptions — confirm with trial site)
• People who have received an anti-cancer vaccine or a live vaccine within the past 4 weeks
• People with an active autoimmune disease, or a history of certain autoimmune conditions (some exceptions may apply, such as stable thyroid conditions or type 1 diabetes — confirm with trial site)
• People with a known immune system deficiency, including HIV, organ transplant recipients, or those who have had a bone marrow transplant
• People with serious, uncontrolled heart conditions, such as significant heart failure, unstable chest pain, a heart attack within the past year, or serious heart rhythm problems
• People who have had a severe infection within the past 4 weeks, or signs of an active infection requiring antibiotics within the past 2 weeks
• People with a history of interstitial lung disease, non-infectious lung inflammation, 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 infections at certain levels (confirm with trial site for specific thresholds)
• People with abnormal sodium, potassium, or calcium levels in blood tests within the past 2 weeks that have not improved with treatment
• People with a known allergy or serious reaction to the trial drug (tirilizumab) or to paclitaxel or cisplatin
• People who have previously had another type of cancer, unless it was a low-risk cancer with a very high survival rate (such as certain skin cancers or cervical pre-cancer that was fully treated) — confirm with trial site
• People who, in the opinion of the trial doctor, have other circumstances that could interfere with safely completing the trial

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