Phase 3 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 18 to 75 years, of any gender.
• People who have been diagnosed with squamous cell carcinoma of the esophagus (a type of throat/food pipe cancer), confirmed through a tissue or cell sample, including those with advanced or metastatic (spread) disease.
• People with a general health and activity level rated as 0 or 1 on a standard medical scale, meaning they are fully active or have minor limitations but are able to carry out light work (confirm with trial site).
• People with a life expectancy of more than 3 months.
• People whose cancer has continued to grow or spread despite two previous standard treatment courses.
• People who are able to provide a stored tumour tissue sample for testing, or who can undergo a new biopsy (small tissue sample taken by a doctor) if no stored sample is available.
• People whose tumour has been confirmed by a central laboratory to have high levels of a protein called EGFR on its surface.
• People who have measurable disease that can be tracked using standard imaging criteria.
• People who are able to swallow tablets or capsules.
• People whose organs (such as liver, kidneys, and bone marrow) are functioning at an adequate level.
• People who are willing to participate voluntarily and sign a consent form.

Who may not be able to join:

• People who have previously been treated with drugs that specifically target EGFR, including EGFR antibody treatments.
• People who have previously been treated with Irinotecan or Tegafur.
• People who have received certain chemotherapy drugs (anthracyclines, nitrosoureas, or mitomycin) within the past 6 weeks, certain traditional Chinese anti-tumour medicines within the past 2 weeks, immune-based anti-tumour therapies within the past 8 weeks, or any other anti-tumour treatment within the past 4 weeks before joining the trial.
• People who have not yet recovered from side effects caused by a previous treatment.
• People who have had major surgery within the past 4 weeks, or who expect to have major surgery during the trial period (routine diagnostic procedures are not included).
• People who are currently taking part in, or have taken part in, another clinical trial within the past 4 weeks.
• People who have received a live vaccine within the past 28 days, or who plan to receive one after joining the trial.
• People who have taken certain medicines that strongly affect how the body processes drugs (strong CYP3A4 inducers or inhibitors) within the past week, or who have taken Sorivudine or a closely related drug within the past 56 days (confirm with trial site).
• People who are currently receiving any other anti-tumour treatment at the same time.
• People who have had another type of cancer in the past 5 years, with the exception of certain skin cancers or any cancer that has been fully cured.
• People who have cancer that has spread to the brain or spinal cord and is not stable or not under control, or who have cancer-related meningitis or spinal cord compression.
• People who have significant digestive system problems that could affect how a drug is taken in or absorbed by the body.
• People who have an active stomach or intestinal ulcer, active gastrointestinal bleeding, or a perforation (a hole in the stomach or bowel wall).
• People who are at high risk of serious bleeding or of developing an abnormal connection (fistula) in the oesophagus (food pipe).
• People who have, or have previously had, scarring or inflammation of the lung tissue (interstitial lung disease), or pneumonia related to immunotherapy; or who currently have lung inflammation requiring steroid treatment, active pneumonia with symptoms, or other moderate to severe lung disease affecting lung function.
• People who have an active infection during the screening period (including infections needing intravenous treatment), or who have had an unexplained fever above 38.5°C in the past 2 weeks.
• People who have a condition that weakens the immune system, either from birth or developed over time, such as HIV infection.
• People with known active Hepatitis B or Hepatitis C infection.
• People who have had a heart attack, certain heart surgeries, significant heart failure, or unstable chest pain (angina) within the past 6 to 12 months (confirm specific timeframes with trial site).
• People who have had a blood clot or stroke (including mini-strokes), deep vein thrombosis, or pulmonary embolism within the past 12 months, including those on blood-thinning treatment for these conditions.
• People with certain heart rhythm abnormalities, a history of a condition called long QT syndrome, a history of serious irregular heartbeats, or a reduced heart pumping function below 50%.
• People who are allergic or have a known contraindication to any ingredient in the study drug (Z650) or to Irinotecan, Tegafur, or their ingredients.
• People who have uncontrolled fluid build-up around the lungs, heart, pelvis, or abdomen that requires repeated draining.
• People who have had an organ transplant or a bone marrow transplant using donor cells.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study period and up to 6 months after the final dose.
• People who have other serious health conditions that the trial doctors consider would make participation unsafe or unsuitable.

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