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 aged 18 to 75 years old, of any gender
• People whose biopsy (tissue sample taken during a stomach camera procedure) has confirmed esophageal cancer, with a specific stage of disease classified as Stage II to Stage IVA (based on how far the cancer has grown and whether it has spread to nearby lymph nodes, but not to distant parts of the body)
• People whose esophageal cancer is not located in the neck area (non-cervical esophageal cancer)
• People who have not previously received any treatment — such as chemotherapy, radiation, or surgery — for their esophageal cancer, and who have at least one area of cancer that can be measured on scans
• People with a good general level of physical functioning, able to carry out daily activities with little or no limitation (rated 0 or 1 on a standard medical scale)
• People whose life expectancy is estimated to be at least 12 months
• People whose major organs — including thyroid, lungs, bone marrow, liver, kidneys, and heart — are functioning at a basically normal level, as assessed by the treating doctor
• Women who are able to become pregnant must have had a negative pregnancy test (blood or urine) within 7 days before joining, and must agree to use reliable contraception during the trial and for 8 weeks after the last dose of trial medication; men must agree to use reliable contraception or have had a sterilisation procedure, for the same period
• People who are willing to voluntarily sign a consent form, follow the trial schedule, attend regular hospital check-ups, and provide blood and tissue samples as required

Who may not be able to join:

• People who have had another cancer within the past 5 years, except for certain fully treated cancers such as early-stage cervical cancer, non-melanoma skin cancer, or certain very early-stage bladder cancers
• People whose esophageal cancer has an ulcerating (open sore) type of growth pattern
• People who have a hole or abnormal opening between the esophagus and another structure such as the airway (esophageal or tracheal fistula)
• People who have a known sensitivity or allergic reaction to any of the trial drugs: anlotinib, pembrolizumab, albumin-bound paclitaxel, or oxaliplatin, or to any of their ingredients
• People with a history of immune system deficiency, including HIV, other inherited or acquired immune conditions, or a history of organ transplantation
• People with serious or uncontrolled health conditions, including: very high blood pressure; heart problems such as reduced blood flow to the heart or a previous heart attack; certain heart rhythm problems; poorly controlled diabetes or treatment requiring high-dose steroids; active or uncontrolled serious infection; severe liver disease or active hepatitis B or C; thyroid problems (overactive or underactive); or active tuberculosis
• People who still have significant side effects (above a mild level) from any previous treatment, apart from hair loss
• People with active bleeding from the main cancer site within the past 2 months
• People whose tumour is growing into or very close to major blood vessels, where the treating doctor considers there to be a high risk of serious bleeding
• People who have difficulty taking oral (swallowed) medications due to conditions such as chronic diarrhoea or bowel blockage — though people with swallowing difficulty who can still drink water may be considered, as one of the trial drugs can be dissolved (confirm with trial site)
• People with a significant level of protein detected in their urine, confirmed by a 24-hour urine test showing more than 1.0 g of protein
• People who have had major surgery, a surgical biopsy, or a significant physical injury within the 28 days before joining the trial
• People with blood clotting problems, a tendency to bleed, or who are currently on blood-thinning or clot-dissolving medication; or who have had a significant bleeding event or have unhealed wounds, ulcers, or fractures within the 4 weeks before joining
• People who have had a blood clot event within the past 6 months, such as a stroke, mini-stroke (TIA), deep vein thrombosis, or pulmonary embolism
• Women who are pregnant or breastfeeding
• People whose cancer has spread to distant parts of the body (distant metastasis)
• People with significantly reduced bone marrow function (confirm with trial site)
• People with a history of mental illness or misuse of psychiatric medications
• People who have taken part in another clinical drug trial within the past 4 weeks
• People with other existing health conditions that the treating doctor believes would seriously affect their safety or their ability to complete the study
• Anyone the investigator considers unsuitable for inclusion for any other reason

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