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 male or female, aged 18 to 75 years old at the time of signing the consent form.
• People who are in good enough general health to carry out daily activities, as measured by standard medical scoring tools (ECOG score of 0–1, or Karnofsky score of 80 or above).
• People who have been confirmed through a tissue sample (biopsy) to have squamous cell cancer of the chest (thoracic) portion of the food pipe (esophagus), where the upper edge of the cancer does not extend beyond the top of the chest.
• People whose cancer is considered removable by surgery, or potentially removable, based on a specific staging system (AJCC/UICC 8th edition), and meets certain stage criteria (T3–4aN0 or T2–4aN+).
• People whose esophageal cancer lesion is less than 8 cm in length.
• People who have no medical reasons preventing them from having surgery.
• People whose heart, lungs, and other organs are functioning well enough to tolerate chemotherapy, radiation, and surgery — including blood counts, kidney function, liver function, clotting ability, and heart pumping strength meeting specific measured thresholds (confirm exact values with the trial site).
• Women who could become pregnant must have a negative pregnancy test within 3 days before starting the study treatment, and must use highly effective contraception from the start of screening until 120 days after the last dose.
• Men with female partners who could become pregnant must use effective contraception from the start of screening until 120 days after the last dose.
• People who are willing and able to follow all study requirements, including scheduled visits, tests, and treatment plans, and who can give informed written consent.

Who may not be able to join:

• People whose cancer is located in the neck (cervical) portion of the food pipe.
• People whose cancer has spread to lymph nodes in the neck or around the celiac artery (a major blood vessel in the abdomen).
• People whose cancer has grown into the windpipe (trachea) or the main artery from the heart (aorta).
• People who have hoarseness caused by the esophageal tumour.
• People who have, or are at risk of developing, a hole or abnormal opening in the food pipe (esophageal fistula).
• People who are pregnant or currently breastfeeding.
• People with severe diabetes that is not well controlled.
• People who cannot use the stomach as a replacement for the food pipe due to previous stomach surgery.
• People who have previously received chemotherapy combined with radiation therapy (chemoradiotherapy).
• People who are allergic to, or have a medical reason to avoid, a group of cancer medicines called taxanes.
• People who are unable to give informed consent for psychological, family, or social reasons.
• People who have a history of any other cancer besides esophageal cancer.
• People who are too unwell to tolerate chemoradiotherapy due to serious heart, lung, liver, kidney, or blood conditions, or severe malnutrition (including a body mass index below 18.5).
• People with an active autoimmune disease, a history of autoimmune conditions (such as colitis, hepatitis, or overactive thyroid), immune deficiency (including a positive HIV test), organ transplant, or bone marrow transplant from a donor.
• People with active hepatitis B or active hepatitis C infections, based on specific blood test results (confirm thresholds with trial site).
• People who are currently taking long-term steroid medicines or other medicines that suppress the immune system.
• People who have had a serious infection requiring hospitalisation within 4 weeks before starting the study, or an active infection requiring treatment within 2 weeks before starting (not including hepatitis B or C antiviral treatment).
• People with known active tuberculosis or known active syphilis infection.
• People who have received a live or weakened-live vaccine within 30 days before starting the study, or who plan to receive one during the study.
• People with a history of interstitial lung disease or non-infectious lung inflammation (pneumonitis).
• People with a history of myocarditis, cardiomyopathy, dangerous heart rhythm problems, unstable chest pain, heart attack, heart failure, or significant blood vessel disease within the 12 months before starting the study, or other serious heart conditions.
• People with known psychiatric disorders, or a history of drug abuse, alcoholism, or substance abuse.
• People with serious non-cancer-related conditions, or cancer-related complications such as extremely high white blood cell counts or significant unintended weight loss (more than 10% of body weight in the 3 months before screening).
• People who, in the opinion of the trial team, have any other condition that could put them at risk, interfere with the study treatment assessment, or affect the study results.

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