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 aged between 18 and 75 years old (inclusive)
• People who are willing to take part, sign a consent form, and follow the study requirements
• People with a good general activity level, rated 0 or 1 on a standard oncology performance scale (this measures how much cancer affects daily activities — confirm with trial site)
• People whose life expectancy is greater than 12 weeks
• People who have at least one tumour that can be measured on a scan, according to standard criteria
• People with blood test results meeting specific thresholds, including healthy enough levels of red blood cells, white blood cells, and platelets, as well as adequate liver and kidney function (these must be measured without the help of blood-boosting medications in the 7 days before testing — confirm exact values with trial site)
• People who have been confirmed by tissue or cell testing to have recurrent or metastatic oesophageal cancer
• People whose oesophageal cancer has stopped responding to, or who could not tolerate, a previous treatment combining an immune checkpoint drug (PD-1/PD-L1 inhibitor) with platinum-based chemotherapy
• People who are willing to provide a tumour tissue sample (either stored from a previous biopsy or freshly collected) for research testing
• Women who could become pregnant must have a negative pregnancy test within 7 days before joining, and must agree to use effective contraception during the study and for 6 months after it ends
• Men must agree to use effective contraception during the study and for 6 months after it ends

Who may not be able to join:

• People who have a current or past history of another cancer (other than oesophageal cancer)
• People with a condition that makes it difficult to access a vein for injections or blood draws
• People who still have side effects from a previous cancer treatment that have not improved to a mild level
• People who have had major surgery or a serious injury within 4 weeks before starting the trial, are scheduled for major surgery during the trial, or have a wound, ulcer, or bone fracture that is not healing
• People who have had a significant bleeding event within 4 weeks before starting the trial
• People who have had a blood clot in a vein or artery (such as a deep vein thrombosis or pulmonary embolism) within the past 6 months
• People with poorly controlled active viral hepatitis
• People with an active syphilis infection currently needing antibiotic treatment
• People with certain lung conditions, including active tuberculosis, pulmonary fibrosis, organising pneumonia, drug- or radiation-related lung inflammation requiring treatment, active symptomatic pneumonia, or a history of serious lung inflammation (interstitial lung disease) that required treatment
• People with a history of substance abuse or psychiatric disorders
• People who have previously received a bone marrow or organ transplant from another person
• People with a history of hepatic encephalopathy (a condition where liver problems affect brain function)
• People with significant heart or cardiovascular disease
• People with an active or uncontrolled serious infection
• People who require dialysis (haemodialysis or peritoneal dialysis) due to kidney failure
• People with a history of immune system deficiency
• People with a poorly controlled autoimmune disease
• People with poorly controlled epilepsy requiring treatment
• People with poorly controlled diabetes
• People who have received other anticancer treatments within 3 weeks before starting the trial, or within 5 half-lives of the previous drug (whichever is shorter — confirm with trial site)
• People who have used certain approved traditional Chinese medicine anticancer products within 1 week before starting the trial
• People whose scans show the tumour is wrapped around major blood vessels in a way that creates a high risk of bleeding
• People with uncontrolled fluid build-up (such as around the lungs or abdomen) that requires repeated drainage
• People with known spinal cord compression, cancer spread to the membranes around the brain or spinal cord, or brain metastases with symptoms or imaging changes that have not been stable for at least 4 weeks
• People with a known allergy or sensitivity to the study drug or any of its ingredients
• People who have previously been treated with a specific type of antibody-drug treatment (topoisomerase I inhibitor-based ADCs) or with irinotecan chemotherapy
• People who have taken part in another anticancer clinical trial within the past 4 weeks
• People whom the trial investigators have concerns about regarding safety or ability to follow the study requirements

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