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 able to understand and willingly sign a consent form before any study procedures begin.
• People aged 18 to 75 years old at the time of signing the consent form.
• People who have a general health and activity level rated as reasonably functional, based on standard medical scoring tools (confirm with trial site).
• People who have been confirmed through tissue testing to have squamous cell carcinoma of the esophagus.
• People whose esophageal cancer was originally considered removable or potentially removable at a certain stage, who then received 2 rounds of pre-surgery immunotherapy and chemotherapy, followed by surgery that completely removed the cancer (R0 resection), but whose post-surgery pathology showed the cancer did not fully disappear (did not achieve a complete response).
• People whose blood, kidney, liver, clotting, and heart function all meet specific minimum levels as tested before the study begins.
• Women who could become pregnant must have a negative pregnancy test within 3 days before the first dose, and must use highly effective contraception continuously until 120 days after the last dose.
• Men who are sexually active with partners who could become pregnant must use effective contraception from the screening period through 120 days after the last dose.
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete all required tests and study procedures.

Who may not be able to join:

• People whose esophageal cancer had already spread to other organs such as the liver, bones, lungs, brain, or adrenal glands at the time of first diagnosis (Stage IV metastatic disease).
• People whose surgery did not fully remove the cancer (did not achieve R0 resection).
• People whose post-surgery pathology showed the cancer had completely disappeared (achieved a complete pathological response).
• People who have previously had radiation therapy to the chest.
• People who had an abnormal opening between the esophagus and nearby structures (such as a fistula to the airway or chest cavity) before treatment.
• People who are pregnant or currently breastfeeding.
• People who are unable to give informed consent due to psychological, family, social, or other reasons.
• People who have had a different type of cancer in the past, unless it was a specific type of non-serious skin cancer, early-stage cervical cancer that was confined to one area, or early-stage prostate cancer that was fully cured.
• People whose heart, lung, liver, or kidney function is too poor to safely tolerate chemotherapy or radiation therapy, or who have severe unintended weight loss.
• People with active autoimmune diseases, a history of autoimmune conditions (such as certain types of colitis, liver inflammation, or thyroid overactivity), a history of immune system deficiency including HIV-positive status, or a history of organ transplant or bone marrow transplant.
• People with active hepatitis B or hepatitis C infections at levels above specified thresholds.
• People who are currently taking long-term steroids or other medications that suppress the immune system.
• People who had a serious infection requiring hospitalisation within 4 weeks before the first dose, or who are currently being treated with systemic antibiotics or antifungals within 2 weeks before the first dose (excluding hepatitis B or C antiviral treatment).
• People with known or suspected active tuberculosis, or known active syphilis.
• People who received a live or weakened-live vaccine within 30 days before the first dose, or who plan to receive one during the study (non-live vaccines are permitted).
• People with a history of scarring or inflammation of the lung tissue (interstitial lung disease or non-infectious pneumonitis).
• People with a history of heart muscle inflammation, heart muscle disease, or dangerous irregular heart rhythms; or people who have had unstable chest pain, a heart attack, heart failure, or significant blood vessel problems within the 12 months before the first dose.
• People with a known psychiatric illness, or a history of substance abuse, alcohol dependence, or drug abuse.
• People with other significant medical conditions unrelated to cancer that could increase health risks or make it difficult to assess survival outcomes, such as very high white blood cell counts or severe unintended weight loss in the 3 months before screening.
• People who have any other condition that the trial doctor considers could put them at risk, interfere with assessing the study drug, or affect how results are interpreted.

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