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 aged 18 to 80 years old, of any gender
• People whose cancer has been confirmed as esophageal squamous cell carcinoma (a type of throat/food pipe cancer) through a tissue or cell sample
• People who have not yet received any treatment for their esophageal cancer, and whose cancer is at a specific stage involving the food pipe wall and/or nearby lymph nodes but has not spread to distant parts of the body (confirm with trial site for exact staging)
• People who are able to provide a tissue sample from their tumour so that a specific protein level (PD-L1) can be measured
• People whose surgical plan includes a full removal of the esophageal cancer with reconstruction using the stomach, along with removal of lymph nodes in at least two regions
• People with a general health and activity level rated as fully active or able to carry out light work (ECOG score of 0 or 1)
• People expected to live at least 12 weeks or more
• People with a body mass index (a measure of body weight relative to height) of 18.5 or above, or who meet a specific nutritional assessment score (confirm with trial site)
• People whose blood test results show healthy levels of blood cells, including white blood cells, neutrophils, platelets, and haemoglobin, without having needed a blood transfusion or blood-boosting treatment in the past 14 days
• People whose liver-related blood test results fall within acceptable ranges, including liver enzymes, bilirubin, and albumin (a blood protein)
• People whose kidney function blood tests are within acceptable ranges
• People whose blood clotting test results are within acceptable ranges
• People with normal or only mildly reduced heart function
• People with adequate lung function based on breathing test measurements (confirm with trial site for specific values)
• People with liver function rated at a mild level on a standard medical scale (Child-Pugh grade 5–6)
• Women who have not yet gone through menopause must have a negative pregnancy test before joining; all participants of childbearing potential (including male participants whose partners could become pregnant) must use contraception from the first dose of study treatment until six months after the last dose
• People who are willing and able to sign a consent form themselves, or have a legal representative sign on their behalf
• People who are able and willing to follow all study procedures and attend follow-up appointments

Who may not be able to join:

• People whose esophageal cancer is located in the upper (cervical) section of the food pipe
• People whose cancer has spread to certain lymph node regions, including the neck, collarbone area, abdomen, the area behind the abdomen, or pelvis (certain other nearby lymph node involvement may still be acceptable — confirm with trial site)
• People who have previously received any treatment for their esophageal cancer, such as surgery, chemotherapy, targeted therapy, immunotherapy, radiation, or other treatments (some traditional herbal medicines stopped more than 7 days prior may be an exception — confirm with trial site)
• People with a current, recurring, or previously active immune system condition where the body attacks its own tissues, with some exceptions for certain mild or well-managed conditions such as controlled type 1 diabetes, thyroid replacement therapy only, or certain skin conditions not requiring systemic treatment (confirm with trial site)
• People who have had a bone marrow or organ transplant in the past
• People with existing lung inflammation or scarring (such as interstitial lung disease or non-infectious pneumonia)
• People who have had serious bowel problems within the past 6 months, including bowel perforation, fistula (abnormal connections between organs), bowel obstruction, inflammatory bowel disease, large bowel removal surgery, Crohn's disease, ulcerative colitis, or chronic diarrhoea
• People who have had major surgery or a serious physical injury within 28 days before the start of the study (minor procedures such as biopsies may be acceptable — confirm with trial site)
• People who have received a live vaccine or are planning to receive one within 28 days before the study starts
• People who have taken high-dose steroid medications or other immune-suppressing medicines within 14 days before the study starts, with some exceptions for short-term or localised steroid use (confirm with trial site)
• People who have had a significant infection requiring systemic treatment (such as antibiotics, antifungals, antiviral drugs, or oxygen) within 14 days before the study starts
• People with certain serious or poorly controlled health conditions, including moderate-to-severe heart failure, unstable chest pain (angina), a heart attack within the past 6 months, serious heart rhythm problems, uncontrolled high blood pressure, blood clots in arteries or veins within the past 2 months, a stroke within the past 6 months, poorly controlled diabetes, poorly controlled thyroid disease, or significant protein in the urine
• People who have received treatment for tuberculosis (TB) within the past year, or who currently have active TB
• People who are HIV positive
• People with active hepatitis B or hepatitis C infection (some people with hepatitis B markers but low virus levels may still be considered if they take specific antiviral medication — confirm with trial site)
• Women who are pregnant or breastfeeding
• People who have had another cancer within the past 5 years, with some exceptions for certain fully treated cancers such as skin cancers, localised prostate cancer, or carcinoma in situ (confirm with trial site)
• People with other serious physical or mental health conditions, or issues with alcohol or substance use, that could affect safety or interfere with the study results
• People whom the study doctor considers unsuitable for any other reason

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