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:

• People who are willing to take part, sign a consent form, attend follow-up appointments, and follow the study plan throughout the trial
• People who have been confirmed by tissue testing to have squamous cell carcinoma of the esophagus, with the tumour located in the chest (thoracic) portion of the esophagus
• People who have not yet received any treatment — either to the whole body or locally — for their esophageal cancer
• People whose cancer has been staged as cT1b-3N1-3M0 or T3N0M0 according to the AJCC/UICC 8th edition staging system (confirm with trial site)
• People aged 18 to 75 years, male or female
• People with a general health performance score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor restrictions on physical activity
• People for whom complete surgical removal of the tumour (with no cancer cells left at the edges) is expected to be possible
• People with adequate heart function, including a heart pumping strength (left ventricular ejection fraction) of more than 50% if they have a heart history or abnormal heart tracing
• People with adequate lung function, measured by specific breathing tests showing results above the required thresholds for airflow and lung capacity
• People with adequate bone marrow function, shown by blood counts and liver enzyme levels within required ranges
• People with adequate liver function, with bilirubin and liver enzyme levels within required limits
• People with adequate kidney function, with a filtration rate above 60 mL/min and creatinine levels within the required range
• Women who could become pregnant must have a negative pregnancy test within 72 hours before starting the study drug, and must use effective contraception during the trial and for at least 3 months after the last dose; male participants whose partners could become pregnant must also use effective contraception during the trial and for at least 3 months after the last dose

Who may not be able to join:

• People whose tumour cannot be surgically removed, who have medical reasons preventing surgery, or who do not want surgery
• People who have cancer spread to the lymph nodes above the collarbone (supraclavicular lymph nodes)
• People in poor nutritional status with a BMI below 18.5 kg/m², unless nutritional support brings this to an acceptable level before enrolment, as assessed by the lead investigator
• People with a known allergy to any of the drugs used in the trial
• People who have already received, or are currently receiving, any radiotherapy, chemotherapy, or other anti-cancer drugs for this cancer; or who are taking immune-suppressing drugs or high-dose steroids (above the equivalent of 10 mg per day of prednisone) within 2 weeks before the first study dose; or who have received a live vaccine within 4 weeks before the first dose; or who have had major surgery or serious injury within 4 weeks before the first dose
• People with an active infection of HIV, hepatitis B, or hepatitis C, or who are known to be HIV positive, or who test positive for hepatitis B or C surface antigens
• People with uncontrolled heart problems, including moderate-to-severe heart failure, unstable chest pain (angina), a heart attack within the past year, or poorly controlled abnormal heart rhythms
• People who have had a serious infection (rated above CTCAE grade 2) within 4 weeks before the first dose, such as severe pneumonia requiring hospitalisation, blood infections, or other serious infectious complications; or who have signs of active lung inflammation, infection symptoms, or have needed antibiotic treatment within 14 days before the first dose
• People who have taken part in another drug clinical trial within 4 weeks before joining this study
• People with interstitial lung disease (scarring or inflammation of the lung tissue), a past history of this condition requiring steroid treatment, pulmonary fibrosis, drug-related lung disease, active tuberculosis, or other lung conditions that may make it difficult to assess or treat immune-related lung side effects
• People with an active autoimmune disease, or a history of autoimmune disease that could come back (such as autoimmune hepatitis, inflammatory bowel disease, vasculitis, or kidney inflammation, among others); some conditions may still be eligible (confirm with trial site); people who have previously been treated with anti-PD-1, anti-PD-L1, or similar immune checkpoint drugs are not eligible
• People diagnosed with another cancer within the past 5 years, unless it was a type with a very low risk of spread or death (such as certain treated skin cancers or cervical carcinoma in situ)
• Women who are pregnant or breastfeeding
• People with other serious conditions — including mental health conditions, alcohol or substance use issues, or other medical or social factors — that the investigators believe could affect safety or the ability to complete the study

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