Phase 2 Oesophageal Cancer Trial, Recruiting

Written by an AI model from the 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 have been diagnosed with esophageal squamous cell carcinoma (a type of throat/food pipe cancer) confirmed by a laboratory test on a tissue or cell sample
• People whose cancer has been assessed as unable to be removed by surgery, is locally advanced, and falls within a specific stage range (Stage II to IVB, where Stage IVB is limited to spread to certain nearby lymph nodes only), based on scans and imaging
• People aged 18 to 80 years, of any gender
• People who are able to take medication by mouth
• People who have not previously received chemotherapy, radiation therapy, surgery, targeted therapy, or immunotherapy for this cancer
• People who are able to provide an adequate stored tumour tissue sample for testing
• People whose doctors estimate they are expected to live for at least 12 weeks
• People who are generally well enough to carry out light daily activities, rated 0 or 1 on a standard medical fitness scale (ECOG scale)
• Women who have gone through menopause, or women who have a negative pregnancy test within 14 days before starting the study drug
• Women who are not breastfeeding
• People whose lungs, blood, kidneys, and liver are functioning well enough to meet specific laboratory test thresholds (confirm with trial site)
• People who have read, understood, and signed a consent form before any study procedures begin

Who may not be able to join:

• People currently taking part in another clinical trial that involves an active treatment or intervention
• People who have used immune-suppressing medications within 28 days before the first dose of the study drug Toripalimab, with some exceptions for low-dose steroids (confirm with trial site)
• People who have previously been treated with certain types of immunotherapy drugs known as anti-PD-1 or anti-PD-L1 antibodies
• People who have had major surgery within 4 weeks before entering the study (not including procedures to place a vascular access device)
• People with a history of an autoimmune disease within the past 2 years
• People with active or past inflammatory bowel disease, such as Crohn's disease or ulcerative colitis
• People with a history of a condition where the immune system does not work properly from birth (primary immunodeficiency)
• People who have had an organ transplant and require immune-suppressing treatment as a result
• People with uncontrolled serious health conditions, including active infections, certain heart conditions, poorly controlled high blood pressure, unstable chest pain, abnormal heart rhythms, active stomach ulcers, active bleeding disorders, certain active viral infections (including hepatitis B with high viral levels, hepatitis C, or HIV), or mental health or social conditions that would make it difficult to follow the study requirements
• People who have received a live vaccine within 30 days before starting the study or within 30 days after receiving Toripalimab
• People who have had another type of cancer in the past 5 years before starting Toripalimab, with some exceptions for certain fully treated skin cancers or cervical carcinoma in situ
• People who are pregnant, breastfeeding, or people of reproductive potential who are not using effective contraception
• People whose cancer has spread to distant parts of the body (beyond the specific lymph nodes mentioned above) during the induction phase of treatment
• People whose cancer has grown locally to a point where a radiation specialist determines that safe radiation treatment is no longer possible
• People whose general health has declined to a fitness score of 2 to 4 on the standard medical scale during the induction phase
• People whose blood, kidney, liver, or lung function falls below the required thresholds at the point of moving to the chemoradiotherapy phase (confirm with trial site)

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