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 able to understand and sign a consent form and are willing to follow the trial's treatment plan and visit schedule
• People aged 18 to 70 years old, of any gender
• People who can provide a stored or fresh tumour tissue sample for testing
• People who have at least one tumour that can be measured using standard imaging criteria (RECIST v1.1)
• People who have been confirmed by pathology to have locally advanced, inoperable, or metastatic squamous cell carcinoma of the oesophagus
• People with an ECOG performance score of 0 or 1 (meaning able to carry out normal daily activities with little to no restriction)
• People with an expected survival of at least 12 weeks
• People whose organs (such as liver, kidneys, and heart) are functioning at an adequate level
• People who are able and willing to use highly effective contraception, if applicable

Who may not be able to join:

• People who have brain or central nervous system metastases that have not been adequately treated, or that are active and causing symptoms
• People with cancer-related pain that cannot be controlled
• People with moderate or severe fluid build-up in the abdomen causing symptoms, or uncontrolled fluid around the lungs or heart
• People who have had a gastrointestinal perforation or fistula (abnormal opening) within the 6 months before starting the trial, or whose tumour poses a high risk of causing bleeding or a fistula due to invasion of nearby structures
• People who have received any anti-cancer treatment within 4 weeks before starting the trial
• People who have previously received an antibody-drug conjugate (a type of targeted cancer drug) that contains a topoisomerase I inhibitor
• People who have recently taken certain medications that strongly interact with specific liver enzymes or drug transporters (CYP3A4, CYP2D6, P-gp, or BCRP), within 5 half-lives of the drug before the first dose (confirm with trial site)
• People who have had major surgery requiring general anaesthesia within 28 days, minor or diagnostic surgery within 7 days before starting the trial, or who have planned elective surgery during the trial
• People who have had certain types or doses of radiation therapy within specified timeframes before starting the trial (confirm with trial site for exact details)
• People whose side effects from previous cancer treatments have not recovered to a mild level (Grade 1 or below on standard scales)
• People who have received a live attenuated vaccine within 28 days before starting the trial or during the trial period
• People who have received systemic immune-suppressing medication within 14 days before starting the trial
• People known or suspected to have interstitial lung disease (a type of lung inflammation or scarring)
• People who have experienced significant blood loss (a single episode of 50ml or more, or 300ml or more in one day) within one month before starting the trial
• People with serious heart or blood vessel disease
• People who have had a blood clot event, such as deep vein thrombosis or pulmonary embolism, within 3 months before starting the trial
• People who have been diagnosed with any other cancer
• People who have had a severe infection within 28 days before the first dose
• People with active hepatitis B or hepatitis C
• People with active tuberculosis within the past year
• People with a known history of immune deficiency
• People with a known severe allergic reaction to any component of the trial drugs (SHR-A2102, SHR-1316, or similar monoclonal antibody or fusion protein medications)
• People whom the trial investigators judge to be unsuitable for any other reason that may affect safety or results

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