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 are willing to take part, have signed a consent form, are able to follow the study requirements, and are willing to attend follow-up appointments
• People aged 75 or older, of any gender
• People who have been confirmed by tissue testing to have locally advanced squamous cell carcinoma (a specific type of cancer) of the oesophagus (food pipe), at a certain stage of the disease, and whose cancer cannot be removed by surgery — whether because surgery is not technically possible, because surgery is medically unsafe for them, or because they have chosen not to have surgery
• People whose tumour tissue tests positive for a protein called PD-L1, with a combined positive score (CPS) of 1 or higher
• People who have at least one tumour lesion that can be measured or assessed according to standard research criteria (RECIST 1.1)
• People who have not previously received any cancer treatment, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, biological therapy, or any experimental treatments
• People with a general health and activity score (ECOG score) of 0 or 1, meaning they are fully active or have only minor limitations in physical activity
• People who are able to provide a tumour tissue sample — either a recent sample (within the last 6 months) or a stored sample prepared in a standard laboratory format — for biological testing
• People with an expected survival of at least 3 months
• People whose blood, liver, and kidney test results meet specific minimum thresholds set by the trial (confirm with trial site for exact values)

Who may not be able to join:

• People who have previously had surgery for oesophageal cancer
• People who have previously developed a fistula (an abnormal internal tunnel or opening) caused by their primary tumour
• People assessed as having a high risk of bleeding in the digestive tract, or of developing a fistula or perforation (hole) in the oesophagus
• People with poor nutritional status who have lost 10% or more of their body weight in the two months before screening, and whose condition has not improved with nutritional support
• People who have had major surgery or a serious injury within the 4 weeks before starting the trial drug
• People with uncontrolled fluid build-up around the lungs, heart, or in the abdomen that requires repeated draining
• People who have previously received anti-PD-1 or anti-PD-L1 immunotherapy, chemotherapy, radiotherapy, or targeted therapy for their cancer
• People who have taken any other experimental (investigational) medication within 4 weeks before starting the trial drug
• People who have needed regular systemic steroid treatment (above a certain dose) or other immune-suppressing medications within 2 weeks before starting the trial drug — with some exceptions for local or low-dose steroid use (confirm with trial site)
• People who have received a cancer vaccine or a live vaccine within 4 weeks before starting the trial drug
• People with a current or past history of active autoimmune diseases (conditions where the immune system attacks the body, such as autoimmune lung inflammation, autoimmune liver disease, or autoimmune heart or kidney conditions) — though some exceptions may apply for certain stable, well-managed conditions (confirm with trial site)
• People with a history of immune deficiency conditions, a positive HIV test, other inherited or acquired immune system disorders, or a history of organ transplant or bone marrow transplant from a donor
• People with serious, uncontrolled heart conditions, including certain types of heart failure, unstable chest pain (angina), a heart attack within the past year, or significant abnormal heart rhythms requiring medical treatment
• People who have had a serious infection (such as severe pneumonia or a bloodstream infection requiring hospitalisation) within 4 weeks before starting the trial drug, or who have signs of active lung infection within 2 weeks before starting the trial drug
• People with a history of interstitial lung disease (scarring or inflammation of the lungs) or non-infectious pneumonia, with confirmed severe lung function impairment
• People with active tuberculosis, a diagnosis of tuberculosis in the year before enrolment, or a past history of tuberculosis that was never properly treated
• People with active hepatitis B or hepatitis C infection based on specific blood test results
• People with abnormal sodium, potassium, or calcium blood levels (above a certain threshold) within 2 weeks before enrolment that cannot be corrected with treatment
• People with known allergies or serious reactions to the trial drugs (serplulimab, paclitaxel, or cisplatin) or to any of their ingredients
• People who have been diagnosed with another cancer, unless it is a type with a very low risk of spreading or causing death (such as certain treated skin cancers or cervical cancer in situ) — confirm with trial site
• People who, in the opinion of the research team, have other serious medical, psychological, family, or social circumstances that could affect their safety or the reliability of the trial data

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