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 and able to sign a written consent form before any trial procedures begin
• Adults aged 18 to 75 years old (male or female)
• People who have been diagnosed with a type of oesophageal cancer called esophageal squamous cell carcinoma (ESCC), confirmed by a tissue biopsy, at a specific stage of the disease (cT1N2M0 or cT2-3N0-2M0 under a standard medical staging system), and whose cancer is considered suitable for complete surgical removal before treatment begins
• People who have not yet received any treatment for this cancer, including surgery, chemotherapy, radiotherapy, or immunotherapy
• People who agree to surgery as part of their treatment and whose surgeon has determined there are no medical reasons preventing them from having surgery
• People who are in reasonably good general health, as measured by a standard performance scale (ECOG score of 0 or 1 — meaning fully active or able to carry out light activity)
• People whose life expectancy is greater than 6 months
• People whose blood counts and organ function meet specific laboratory levels within the past 14 days, including: sufficient levels of white blood cells, platelets, and red blood cells (without recent transfusions or certain medications); liver function within acceptable limits; kidney function within acceptable limits; normal blood clotting measurements; thyroid hormone levels within a normal or near-normal range; and heart enzyme levels within normal range
• Women who could become pregnant must have a negative pregnancy test (urine or blood) within 3 days before the first dose of the study drug
• All participants (male or female) where there is any risk of conception must use highly effective contraception (with a failure rate of less than 1% per year) throughout treatment and for 120 days after the last dose of the study drug, or 180 days after the last chemotherapy dose

Who may not be able to join:

• People diagnosed with another type of cancer within the past 1.5 years (certain skin cancers that have been fully treated may be exceptions — confirm with trial site)
• People with known signs of active bleeding seen during an internal camera examination of the oesophagus
• People currently taking part in another interventional clinical trial, or who have received another experimental drug or used an experimental medical device within 4 weeks before the first dose
• People who have previously been treated with certain types of immunotherapy drugs that work on specific immune system pathways (including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, and similar drugs)
• People who have received certain traditional Chinese medicines with anti-tumour effects, or immune-modifying drugs (such as thymosin, interferon, or interleukin, except for local use) within 2 weeks before the first dose
• People who have had an active autoimmune disease requiring ongoing systemic treatment within the past 2 years (note: hormone replacement therapies such as thyroid medication or insulin are not considered systemic treatment in this context)
• People who have been taking steroid medications that affect the whole body (not just topical sprays or inhalers) within 7 days before the first dose, at doses above a low threshold (confirm with trial site), or any other whole-body immune-suppressing medications
• People who have had an organ transplant from another person (other than a corneal transplant), or a stem cell transplant from another person
• People with a known allergy to any of the medications used in this trial
• People who have not fully recovered from side effects or complications of a previous medical procedure before starting treatment (confirm with trial site)
• People with a known history of HIV infection (HIV 1/2 antibody positive)
• People with untreated, active hepatitis B infection — though people with hepatitis B who meet certain specific viral load criteria and agree to take anti-hepatitis B medication during the trial may still be considered (confirm with trial site)
• People with active hepatitis C infection (confirmed by positive antibody and detectable virus levels)
• People who have received a live vaccine within 30 days before the first dose (certain inactivated flu vaccines may be permitted — confirm with trial site)
• Women who are pregnant or currently breastfeeding
• People with serious or uncontrolled health conditions, including:
  • Significant abnormal heart rhythm or electrical conduction problems on a heart tracing (ECG)
  • Unstable chest pain, heart failure, or moderate-to-severe chronic heart failure
  • A heart attack, stroke, or similar blood vessel event within the past 6 months
  • Blood pressure that is not well controlled (above 140/90 mmHg)
  • A history of lung inflammation (not caused by infection) that required steroid treatment within the past year, or currently active lung scarring/inflammation
  • Active tuberculosis affecting the lungs
  • An active infection requiring whole-body (systemic) treatment
  • Active bowel or abdominal conditions such as diverticulitis, abdominal abscess, or bowel blockage
  • Serious liver conditions such as cirrhosis or active hepatitis
  • Poorly controlled diabetes (fasting blood sugar above 10 mmol/L)
  • Significant protein detected in the urine, confirmed by a 24-hour urine test showing more than 1.0g of protein
  • A mental health condition that would prevent the person from cooperating with treatment
  • Any other medical history, condition, or abnormal test result that the trial doctor considers unsuitable for participation

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