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:

• Adults between 18 and 75 years old, of any gender.
• People who have been confirmed by laboratory tissue testing to have esophageal squamous cell carcinoma (a specific type of oesophageal cancer) that has come back or spread to other parts of the body.
• People whose cancer has grown or worsened during or after first-line (initial) treatment with chemotherapy, or who were unable to tolerate that treatment — including certain situations where chemotherapy was given alongside radiation or as treatment before or after surgery (confirm with trial site for specific scenarios).
• People who have at least one area of cancer that can be measured or assessed using standard imaging criteria, and that area has not been treated with radiation (or, if it has, it must show confirmed growth meeting standard measurement criteria).
• People who can provide a tissue sample for testing — either a fresh sample or, if that is not possible, archived tissue sections preserved in paraffin.
• People with a general health and activity level rated as 0 or 1 on a standard medical scale, meaning they are fully active or have only minor limitations in physical activity.
• People who are able to swallow tablets normally.
• People who are expected to live for at least 12 weeks.
• People whose blood test results show that major organs (including bone marrow, liver, and kidneys) are functioning within acceptable ranges as defined by the trial (confirm with trial site for specific values).
• Women who could become pregnant must have a negative blood pregnancy test within 72 hours before the first dose and must agree to use effective contraception during the trial and for a specified period after the last dose. Men with partners who could become pregnant must be surgically sterilised or agree to use effective contraception for the same period. Sperm donation is not permitted during the study.
• People who have chosen to join voluntarily, have signed a consent form, and are willing to attend follow-up appointments.

Who may not be able to join:

• People with significant, uncontrollable fluid build-up in body cavities (such as large amounts of fluid around the lungs or in the abdomen) that cannot be managed by drainage or other methods.
• People with ongoing diarrhoea conditions (such as irritable bowel syndrome, Crohn's disease, or ulcerative colitis) or bowel obstruction that may affect how medication is taken in and absorbed.
• People who have been taking corticosteroid medications (a type of anti-inflammatory drug) continuously for more than 30 days, or who need to take them long-term.
• People who have had radiotherapy, chemotherapy, hormone therapy, surgery, or targeted therapy within the 4 weeks before joining the trial; or who have had certain specific chemotherapy drugs (nitrosoureas or mitomycin) within the 6 weeks before joining.
• People who still have side effects from previous cancer treatments that have not recovered to a mild level (with some exceptions such as hair loss or fatigue, as assessed by the trial doctor).
• People who have taken part in another clinical drug trial within the past 4 weeks (unless that trial was observational only or in a follow-up phase).
• People who have persistently low potassium or magnesium levels in the blood that cannot be corrected.
• People who have brain metastases (cancer that has spread to the brain) that are causing symptoms or have not been treated.
• People who have had another type of cancer in the past 5 years, except for certain fully treated skin cancers or cervical carcinoma in situ.
• People who are currently receiving other cancer treatments at the same time.
• People who are known to be allergic to any ingredient in the study medications.
• People who have a tendency toward gastrointestinal bleeding, including active stomach ulcers with significant test results, a recent history of blood in vomit or black stools within the past 2 months, or visible active bleeding seen on a stomach scope (confirm with trial site for specific details).
• People with active infections, including tuberculosis.
• People with a history of immune system deficiency, a positive HIV test, other immune conditions, or a history of organ transplantation.
• People who have had serious heart problems in the past 6 months, such as a heart attack, significant heart rhythm problems, heart failure, or other heart conditions the trial doctor considers unsuitable.
• Women who are pregnant or breastfeeding, or women of childbearing potential whose pregnancy test at the start of the trial is positive.
• People with serious other health conditions — such as uncontrolled high blood pressure, severe diabetes, or thyroid disorders — that the trial doctor believes could put the person at risk or prevent the trial from being completed properly.
• People with habitual alcohol use or smoking of 5 or more cigarettes per day, or heavy episodic drinking as defined by the trial.
• People with a confirmed history of neurological or psychiatric conditions, including epilepsy or dementia.

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