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 willing to participate voluntarily, have signed a consent form, and are able to attend follow-up visits as required.
• People who have been confirmed by tissue testing to have esophageal squamous cell carcinoma (a type of oesophageal cancer) that cannot be surgically removed, has come back, or has spread — not including a mixed type called adenosquamous cell carcinoma.
• People who have not received any previous full-body (systemic) cancer treatment, or who have had surgery or chemoradiotherapy aimed at curing the cancer but whose cancer came back more than 6 months after that treatment ended (confirm with trial site for specific details around prior palliative treatment timing).
• People who have at least one tumour that can be measured using standard imaging criteria (called RECIST 1.1).
• People aged between 18 and 75 years old.
• People who have a good general level of physical function, rated 0 or 1 on a standard scale used by oncologists (meaning largely able to carry out daily activities with little or no restriction).
• People whose life expectancy is more than 3 months.
• People whose blood counts and organ function meet certain minimum levels — including blood cell counts, liver function, kidney function, blood clotting ability, heart function, and heart enzyme levels — based on recent test results taken without recent transfusions or certain medications (confirm specific values with trial site).
• Women who could become pregnant must use appropriate contraception from the screening period until 3 months after treatment ends, must not be breastfeeding, and must have a negative pregnancy test or confirmed reason for not being able to become pregnant before starting treatment. Men must agree to use contraception or have had surgical sterilisation during the trial and for 8 weeks after the last dose.

Who may not be able to join:

• People who have previously been treated with anti-EGFR, anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody therapies (certain types of targeted or immunotherapy drugs).
• People whose oesophageal cancer is causing a near-complete blockage of the oesophagus and who need a procedure to relieve that blockage.
• People whose tumour has grown into nearby major structures such as large blood vessels or the windpipe, creating a high risk of serious bleeding or perforation, or who already have an abnormal opening (fistula) between the oesophagus and nearby structures.
• People who have had major surgery, an open biopsy, or a serious injury within 28 days before enrolling.
• People who have difficulty swallowing, chronic diarrhoea, bowel obstruction, or a known severe allergy to any ingredient in the study drugs, as these could affect how the body absorbs the treatment.
• People who have received certain traditional Chinese medicine anti-tumour treatments within the past 2 weeks (people who have been taking these treatments continuously for more than 2 weeks may still be considered — confirm with trial site).
• People whose cancer has spread to the liver so extensively that it takes up more than 50% of the total liver volume.
• People with serious uncontrolled health conditions, which include:
  • High blood pressure that is not well controlled despite medication, or a history of hypertensive crisis or hypertensive brain swelling.
  • Significant heart problems such as heart attack history, certain abnormal heart rhythms, moderate-to-severe heart failure, unstable chest pain, or prior heart bypass surgery.
  • Active or uncontrolled serious infection, or known active tuberculosis.
  • Kidney failure requiring dialysis.
  • Serious liver conditions such as cirrhosis, liver disease that is no longer compensated, or chronic active hepatitis.
  • Poorly controlled diabetes (fasting blood sugar above 10 mmol/L).
  • Significant amounts of protein found in the urine on testing.
• People with long-term untreated wounds or fractures.
• People who have brain metastases causing symptoms, or cancer that has spread to the membranes surrounding the brain or spinal cord.
• People with a clinically significant build-up of fluid in the abdomen (ascites that can be felt on physical examination or that has required treatment).
• People with significant fluid build-up around both lungs, or a large amount around one lung, or fluid causing breathing difficulties that requires drainage.
• People with a type of lung disease called interstitial lung disease that requires steroid treatment.
• People with uncontrolled metabolic disorders or other serious non-cancer conditions that could affect safety or the reliability of study results.
• People with a history of psychotropic substance abuse that cannot be resolved, or who have a significant mental health disorder.
• People with a known history of immune deficiency, HIV infection, other immune deficiency conditions, or who have had an organ transplant.
• People with a history of another type of cancer, unless: it has been in complete remission for at least 2 years and requires no further treatment during the study; it is a type of non-melanoma skin cancer that has been adequately treated with no signs of return; or it is an in-situ cancer (very early, localised cancer) that has been fully treated with no signs of return.
• People with certain immune-related conditions or treatments, including:
  • Active or past autoimmune diseases (such as autoimmune hepatitis, certain lung, bowel, blood vessel, or kidney conditions), or asthma requiring medical treatment — though some conditions such as vitiligo, well-controlled type 1 diabetes, or treated hypothyroidism with normal thyroid levels may still be eligible (confirm with trial site).
  • People currently taking immune-suppressing medicines, including steroid tablets above a low threshold dose, within 2 weeks before the first dose.
  • People who have received any live, weakened, or inactivated vaccine within 4 weeks before enrolling, or who plan to receive such a vaccine during the study; or who have used immune-stimulating agents such as interferon or IL-2 within 2 weeks before starting treatment.
• People who are currently pregnant or breastfeeding.
• People whose overall health condition, in the opinion of the treating doctor, poses serious risks to safety or would prevent them from completing the study.

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