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 voluntarily, have signed a consent form, and are able to follow the study requirements
• Adults aged 18 or older, of any gender
• People who have been diagnosed through a tissue biopsy with locally advanced esophageal squamous cell carcinoma (a specific type of throat/food pipe cancer) at stage II–IV, where the cancer cannot be removed by surgery, or surgery is not recommended or has been declined — with certain specific staging criteria as defined by medical guidelines (confirm with trial site)
• People who have at least one tumour that can be measured using standard imaging criteria
• People who have not yet received any cancer treatment of any kind, including chemotherapy, radiation, targeted therapy, immunotherapy, or any experimental treatments
• People with a performance status score of 0 or 1 on the ECOG scale, meaning they are either fully active or have only mild limitations in physical activity
• People whose doctors expect them to survive for at least 6 months
• People whose blood counts, liver function, kidney function, and other organ tests meet specific minimum levels set by the trial (confirm exact values with trial site)
• People whose blood clotting test results fall within acceptable ranges, or who are on a stable dose of blood-thinning medication with clotting levels within the expected treatment range (confirm with trial site)
• Women who could potentially become pregnant must have a negative pregnancy blood test at the start of the trial and must use reliable contraception from the time of signing consent until 3 months after the last dose

Who may not be able to join:

• People who have previously had surgery for esophageal cancer
• People who have had a fistula (an abnormal opening or tunnel) caused by the tumour invading nearby tissue
• People considered to be at high risk of gastrointestinal bleeding, an opening forming between the food pipe and airway (esophageal fistula), or a tear in the food pipe (esophageal perforation)
• People in poor nutritional health who lost more than 10% of their body weight in the 2 months before screening, with no meaningful improvement after nutritional support
• People who have had major surgery or a serious injury within 4 weeks before the first dose
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires repeated draining
• People who have previously received or are currently receiving anti-PD-1 or anti-PD-L1 immunotherapy, chemotherapy, radiation, or targeted therapy; or who have taken any experimental drug within 4 weeks before the first dose; or who have used high-dose steroids or immune-suppressing medications within 2 weeks before the first dose (with some exceptions for local use or prevention of allergic reactions — confirm with trial site); or who have received an anti-tumour or live vaccine within 4 weeks before the first dose
• People who have an active autoimmune disease or a history of autoimmune disease (such as lung inflammation, eye inflammation, bowel inflammation, liver inflammation, thyroid problems, or heart/kidney/blood vessel inflammation); some exceptions may apply for people with stable, well-managed conditions such as thyroid replacement therapy or insulin-treated type 1 diabetes (confirm with trial site)
• People with a history of immune system deficiency, including HIV-positive status, other immune deficiency conditions, or a history of organ transplant or bone marrow transplant from a donor
• People with serious or uncontrolled heart conditions, including moderate-to-severe heart failure, unstable chest pain (angina), a heart attack within the past year, or significant abnormal heart rhythms requiring treatment
• People who had a serious infection within 4 weeks before the first dose (such as severe pneumonia requiring hospitalisation or a bloodstream infection); or people with signs of active lung inflammation on recent scans, or who needed antibiotic treatment within 2 weeks before the first dose
• People with a history of interstitial lung disease, non-infectious lung inflammation, or confirmed significant loss of lung function (grade 3 or higher)
• People with active tuberculosis, or a history of active tuberculosis within the past year, or a history of tuberculosis more than a year ago that was not properly treated
• People with active hepatitis B or hepatitis C infection at levels above specified thresholds (confirm exact values with trial site)
• People with abnormal sodium, potassium, or calcium blood levels above grade 1 within 2 weeks before enrolment that did not improve with treatment
• People who are allergic to any of the study drugs or their ingredients
• People who have previously had a stem cell or bone marrow transplant
• People who have been diagnosed with another cancer before joining the trial, unless it is a type with a very low risk of spreading or causing death (such as certain treated skin cancers or cervical carcinoma in situ)
• People who, in the opinion of the research team, have other circumstances that may require them to leave the study early

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