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 have been confirmed by tissue or cell testing to have squamous cell carcinoma of the esophagus, at a stage classified as Stage II through IVb (including certain tumour and lymph node combinations, or spread limited to lymph nodes near the collarbone).
• People whose cancer was considered potentially curable by surgery, but who either cannot tolerate surgery or have chosen not to have it.
• People aged between 70 and 85 years old.
• People with a general health and activity level rated as 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physical activity (confirm with trial site).
• People who received a specific type of radiotherapy called intensity-modulated radiotherapy (IMRT) at a total dose of around 54Gy (within 10% of this amount).
• People who received a specific chemotherapy drug called S-1 at a dose of 70mg/m², taken on set days during radiotherapy, running alongside radiotherapy for at least 14 days.
• People whose last round of chemotherapy finished at the same time as or before their last radiotherapy session — no chemotherapy after radiotherapy or before chemoradiotherapy was received.
• People whose cancer did not grow or spread after chemoradiotherapy — meaning the cancer completely responded, partially responded, or stayed stable.
• People whose side effects from previous cancer treatment have mostly settled down to a mild level (Grade 1 or lower) before joining, except for hearing loss, hair loss, or tiredness.
• People who would receive the first dose of the study drug within 42 days of finishing chemoradiotherapy.
• People with no esophageal perforation, no active bleeding in the esophagus, no significant invasion of the windpipe or major chest blood vessels, no interstitial pneumonia or history of it, and a lung function reading (FEV1) of at least 0.8 litres.
• People with an expected survival of at least 3 months.
• People whose blood test results meet specific levels, including: sufficient red blood cells, platelets, and white blood cells; kidney function within an acceptable range; liver function within an acceptable range; and blood clotting levels within an acceptable range (people on stable anticoagulant therapy such as low molecular weight heparin or warfarin may also be considered — confirm with trial site).
• People who have read, understood, and signed the formal consent form for the study.

Who may not be able to join:

• People who had surgical removal of their esophageal cancer before this trial, or who have previously been treated with immune checkpoint inhibitor drugs (such as anti-PD-1, PD-L1, or CTLA-4 inhibitors).
• People whose cancer stage means surgery is considered appropriate and recommended for them.
• People whose cancer continued to grow or spread after chemoradiotherapy.
• People considered at high risk of serious gastrointestinal bleeding, or of developing a hole or abnormal opening in the esophagus.
• People with a history of interstitial lung disease, non-infectious pneumonia, lung scarring (pulmonary fibrosis), or other serious uncontrolled lung conditions.
• People with poor nutritional status, defined as a BMI below 18.5 kg/m², or a nutrition assessment score (PG-SGA) of 9 or higher.
• People who are unlikely to understand or follow the requirements of the trial.
• People whose cancer has spread through the bloodstream to other parts of the body.
• People who have or have had another cancer, unless it was a curable form of non-melanoma skin cancer, cervical carcinoma in situ, or a cancer that was cured more than 5 years ago.
• People with known severe allergic reactions (Grade 3 or 4) to any component of the trial treatment.
• People who have participated in another clinical trial within the past 30 days.
• People with active autoimmune diseases or a history of autoimmune diseases — exceptions may include vitiligo, certain resolved asthma cases, stable autoimmune-related hypothyroidism managed with thyroid hormone replacement, or Type 1 diabetes managed with stable insulin doses (confirm with trial site).
• People with a history of immune system deficiency, including HIV-positive status, other immune deficiency conditions, or a history of organ transplantation or bone marrow transplantation from a donor.
• People with uncontrolled heart conditions, including moderate-to-severe heart failure, unstable chest pain (angina), a heart attack within the past year, or serious heart rhythm problems requiring treatment.
• People with active tuberculosis, a history of active tuberculosis in the past year, or a history of tuberculosis more than a year ago that was not properly treated.
• People with active hepatitis B or hepatitis C infection, based on specific laboratory test results.
• People who, in the investigator's judgement, have other medical conditions that could pose serious safety risks or interfere with completing the study.

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