Phase 3 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 willing to sign a consent form and agree to follow the study's requirements
• People of any gender are eligible
• People aged 18 to 75 years old at the time of signing the consent form
• People with a life expectancy of at least 3 months
• People diagnosed with esophageal squamous cell carcinoma (a type of throat/food pipe cancer) that cannot be surgically removed, has come back, or has spread, and who have not yet received first-line (initial) treatment for advanced disease
• People who have at least one tumour that can be measured using standard imaging criteria (known as RECIST v1.1)
• People who are able to provide a stored tumour tissue sample from the last 3 years
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity)
• People whose side effects from any previous cancer treatment have largely resolved to a mild level or better
• People with no severe heart problems and a heart pumping function (left ventricular ejection fraction) of at least 50%
• People whose organ function (such as liver, kidneys, and blood) meets the levels required by the trial
• People with normal blood clotting results within the ranges specified by the trial
• People with low or no protein detected in their urine
• Women of childbearing age who have a negative pregnancy test within 7 days before starting treatment and who are not breastfeeding; all participants, regardless of gender, must use effective barrier contraception throughout treatment and for 7 months after treatment ends

Who may not be able to join:

• People whose esophageal cancer contains cancer cell types other than squamous cell carcinoma
• People who have used immune-modifying medications in the 2 weeks before the first study dose
• People who have previously been treated with a type of targeted drug (called an ADC) that uses a topoisomerase I inhibitor as its active component
• People whose esophageal cancer is considered suitable for treatment aimed at a cure using local therapies
• People who have received radiotherapy or major surgery with curative intent within 4 weeks before joining the trial
• People currently taking high-dose steroid tablets long-term (for example, more than 10 mg per day of prednisone)
• People who have previously received immunotherapy drugs targeting PD-1, PD-L1, or PD-L2
• People with a history of serious heart or stroke-related conditions
• People with certain abnormal heart rhythm findings on testing (confirm with trial site)
• People with active autoimmune or inflammatory diseases
• People diagnosed with another active cancer within the past 3 years
• People with high blood pressure that remains poorly controlled despite taking two blood pressure medications
• People with poorly controlled blood sugar levels
• People with a history of lung inflammation (interstitial lung disease) that required steroid treatment
• People who have had serious blood clot events requiring treatment within the past 6 months
• People with significant fluid build-up in body cavities (such as around the lungs or abdomen) (confirm with trial site)
• People with serious lung conditions that significantly affect their ability to breathe
• People whose scans show the tumour is growing into or wrapping around major blood vessels in the chest, abdomen, neck, or throat
• People whose tumour is pressing on or growing into the windpipe or airways, causing symptoms such as coughing
• People with a hole (fistula) between the food pipe and nearby organs caused by the tumour, or people the trial doctor believes may be at risk of developing one
• People who have had a stent placed in their windpipe or food pipe for any reason
• People who have had significant bleeding or a clear tendency to bleed within 4 weeks before signing the consent form
• People with a body mass index (BMI) below 18.5, or who have lost 10% or more of their body weight in the 2 months before screening
• People with cancer that has actively spread to the brain or central nervous system
• People with a known allergy to the type of antibody used in the study drug (BL-B01D1) or any of its ingredients
• People who have had an organ transplant or bone marrow/stem cell transplant from a donor
• People who test positive for HIV, or who have active tuberculosis, active hepatitis B, or active hepatitis C
• People who have had a serious infection within 4 weeks before joining the trial
• People with a history of serious neurological or psychiatric conditions
• People with a history of substance misuse that may affect their ability to follow the trial requirements
• People with a serious wound, ulcer, or bone fracture that has not healed within the 4 weeks before signing the consent form
• People with inflammatory bowel disease, a history of large bowel removal, immune-related bowel inflammation, bowel obstruction, or ongoing severe diarrhoea
• People who have taken part in another unapproved clinical trial or received an experimental treatment within 4 weeks before joining
• People who have received or plan to receive a live vaccine within 28 days before the first dose
• Women who are pregnant or breastfeeding
• People with other serious health conditions, abnormal test results, or other factors that the trial doctor believes would make participation unsafe or unsuitable

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