Phase 2 Head and Neck 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, of any gender.
• People who have been diagnosed with oesophageal squamous cell cancer (a specific type of oesophageal cancer) through a tissue or cell sample, where the cancer is advanced, cannot be surgically removed, and has either spread to nearby lymph nodes or to other parts of the body.
• People whose cancer got worse or who could not tolerate a first round of treatment — either chemotherapy (one group) or immunotherapy (other groups).
• People whose cancer responded to or stayed stable on first-line immunotherapy (showing complete response, partial response, or stable disease) for at least 3 months before getting worse.
• People who have at least one tumour that can be measured on a scan and has not been treated with a local therapy such as radiation (with some exceptions — confirm with trial site).
• People who are able to provide a tissue sample for testing, either a fresh biopsy or stored tissue slides.
• People with a performance status score of 0 or 1, meaning they are fully active or able to carry out light activities (confirm with trial site).
• People expected to survive for at least 12 weeks.
• People whose blood test results show that the blood, liver, and kidney are functioning well enough to meet specific thresholds (confirm exact values with trial site).
• People whose heart ultrasound shows the heart is pumping blood adequately (at least 50% efficiency).
• Women of childbearing age who agree to use contraception during the trial and for 6 months after it ends, who test negative for pregnancy within 7 days before joining, and who are not breastfeeding.
• Men who agree to use contraception during the trial and for 6 months after it ends.
• People who join voluntarily, sign a consent form, and are willing to follow the trial schedule and attend follow-up appointments.

Who may not be able to join:

• People who have an active autoimmune disease or a history of autoimmune conditions such as autoimmune hepatitis, lung inflammation, eye inflammation, bowel inflammation, or similar conditions; people with an overactive thyroid; or people who needed medical treatment for asthma as an adult; or people who experienced severe immune-related side effects (Grade 3 or above) from previous treatment.
• People who had radiation therapy in the past and developed radiation-related lung damage, still have unresolved side effects from radiation, or still need steroid medications as a result.
• People who are currently taking immune-suppressing medications or high-dose steroid hormones (above a certain daily dose) and have continued these within the 2 weeks before joining.
• People whose oesophageal cancer tumour is actively bleeding.
• People who have previously been treated with the same type of drug being studied in this trial (not counting immune checkpoint inhibitor drugs).
• People who have difficulty taking oral medications, such as those unable to swallow, who have had part of their digestive tract surgically removed, who have long-term diarrhoea, or who have a bowel blockage (if the trial drug is taken by mouth).
• People who have cancer that has spread to the brain, or whose brain metastases have been treated but resolved less than 3 months ago.
• People with serious or uncontrolled health conditions, including very high blood pressure, heart disease (such as reduced blood flow to the heart, heart attack history, certain abnormal heart rhythms, or heart failure), serious active infection, significant liver disease (such as liver failure, active hepatitis B or C), or high levels of protein in the urine.
• People with wounds or bone fractures that have not healed over a long period of time.
• People who have had significant bleeding from the lungs or from other sites in the 4 weeks before joining, who have a known tendency to bleed (such as an active stomach ulcer), or who are currently taking blood-thinning or clot-dissolving medications such as warfarin or heparin.
• People who have experienced a blood clot or blockage in an artery or vein in the 6 months before joining, such as a stroke, mini-stroke, deep vein thrombosis, or pulmonary embolism.
• People whose tumour is growing close to or into major blood vessels in a way that could cause life-threatening bleeding, as assessed by the treating doctor.
• People who are pregnant or breastfeeding.
• People who have had another type of cancer in the past 5 years, with the exception of certain fully treated skin cancers or cervical pre-cancer.
• People with a history of abusing certain medications affecting mental health, or who have a diagnosed mental health disorder.
• People who have taken part in another clinical drug trial within the past 4 weeks.
• People who have other health conditions that the treating doctor believes could put them at risk or prevent them from completing the trial.
• People considered unsuitable by the treating doctor for any other reason.

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