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 take part in clinical research, have fully understood the study, and are willing to sign a consent form and follow all study procedures
• People aged 18 to 75 years old at the time of signing the consent form
• People who have been diagnosed with esophageal squamous cell carcinoma (a specific type of oesophageal cancer) confirmed by laboratory testing of tissue or cell samples
• People with advanced esophageal squamous cell carcinoma whose cancer has stopped responding to, or who could not tolerate, their first standard treatment (the definition of "first standard treatment" depends on whether the tumour tests positive or negative for a protein called PD-L1, so the trial site can confirm which applies)
• People who have at least one measurable area of cancer that has been assessed within the 4 weeks before starting the trial, following specific measurement guidelines (called RECIST v1.1)
• People who are able to provide a tumour tissue sample for PD-L1 testing during the screening period, where possible
• People who have had enough time pass since their last cancer treatment before starting the trial drug, and whose treatment-related side effects have settled down to a mild level (the trial site can confirm the specific timeframes for different treatment types)
• People whose physical functioning has been assessed as good (scored 0 or 1 on a standard scale called the ECOG scale) in the week before joining the trial
• People with an expected survival of at least 3 months
• People whose organ function (such as liver, kidneys, and blood counts) meets required levels based on blood tests taken within the 14 days before the first dose, without having received blood transfusions or certain growth factor treatments beforehand
• People of childbearing potential who agree to use at least one highly effective form of contraception throughout the trial and for at least 6 months after the last dose; women of childbearing potential must also have a negative pregnancy test within 7 days before enrolling

Who may not be able to join:

• People who have had another type of cancer diagnosed within the 2 years before joining the trial
• People with a body mass index (BMI) below 17.5 kg/m²
• People with cancer that has spread to the brain or the lining of the brain/spinal cord, where symptoms are present, untreated, or getting worse
• People who still need frequent fluid drainage from around the lungs, heart, or abdomen, even after appropriate treatment
• People with a history of severe radiation-related lung inflammation (grade 3 or higher), a history of non-infectious lung scarring (interstitial lung disease) that required steroid treatment, a current lung scarring condition, or imaging results during screening that cannot rule out lung scarring; also people with other lung conditions causing serious breathing difficulties
• People with poorly controlled heart or blood vessel conditions, including: moderate-to-severe heart failure; unstable chest pain (angina); a heart attack or stroke within the last 6 months (with some exceptions the trial site can clarify); uncontrolled irregular heart rhythms or a specific abnormal heart measurement on an ECG; or high blood pressure that remains above a certain level despite treatment
• People who are planning to have, or who have already had, an organ or bone marrow transplant
• People who have had an active, serious infection requiring intravenous (IV) antibiotics within the 2 weeks before joining the trial
• People who have taken certain specific medications that strongly affect how the body processes drugs (strong CYP2D6 or CYP3A inhibitors or inducers) within the 2 weeks before joining (confirm with trial site)
• People who have been taking systemic steroid medications above a low dose threshold, or other immune-suppressing treatments, within the 14 days before the first dose, with some specific exceptions the trial site can clarify
• People who previously had to permanently stop immunotherapy due to side effects, or who have had moderate-to-severe immune-related lung inflammation or heart muscle inflammation from prior treatment
• People with an active or suspected autoimmune disease, with some exceptions: people with autoimmune-related underactive thyroid who are on thyroid hormone replacement may be eligible, and people with controlled Type 1 diabetes using insulin may also be eligible (confirm with trial site)
• People who have received a live or weakened live vaccine within 4 weeks before the first dose (standard inactivated flu vaccines are permitted)
• People with a known history of severe allergic reactions to monoclonal antibody medicines or large protein-based treatments, or allergy to any ingredient in the trial drug; also people who have previously been treated with a specific type of cancer drug (called an antibody-drug conjugate, or ADC) that works using a topoisomerase I inhibitor
• People with active tuberculosis
• People living with HIV
• People who are pregnant or breastfeeding
• People whom the trial doctor considers unsuitable for the trial for any other reason

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