Phase 2 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:

• The patient, or their legal representative, is able to sign a consent form and agrees to follow the study's requirements
• People aged 18 to 74 years old at the time of signing the consent form, of any gender
• People who have been diagnosed with esophageal squamous cell carcinoma (a type of oesophageal cancer) confirmed by a tissue sample and imaging scans, where the cancer is locally advanced and cannot be surgically removed — either because surgery is not medically appropriate or the person has declined it — and where combined chemotherapy and radiotherapy is considered suitable (this covers certain cancer stages as classified by a standard staging system)
• People with a life expectancy of at least 6 months
• People whose general physical condition falls within an acceptable range on a standard medical scale used to measure how much cancer affects daily living (a score of 0–2 on the ECOG scale)
• People who have at least one area of cancer that can be measured or tracked using standard imaging criteria
• People who have not previously received any systemic cancer treatment, including chemotherapy, radiotherapy, immunotherapy, targeted therapy, or any experimental treatments
• People whose blood counts, kidney function, and liver function meet specific levels measured within 14 days before joining the trial — without the need for recent blood transfusions or medications to boost those levels (confirm with trial site for exact values)
• People with a hepatitis B infection who have a very low level of the virus in their blood during screening, and who have been on antiviral treatment for more than 2 weeks before joining if antiviral therapy is being used
• Women who could become pregnant must agree to use highly effective contraception during the study, for at least 120 days after the last dose of the immunotherapy drug, and for at least 180 days after the last dose of chemoradiotherapy, and must have a negative pregnancy test within 7 days before joining
• Men who have not had a sterilisation procedure must agree to use highly effective contraception during the study, for at least 120 days after the last dose of the immunotherapy drug, and for at least 180 days after the last dose of chemoradiotherapy

Who may not be able to join:

• People with a history of other cancers
• People who have had a fistula (an abnormal tunnel or opening) caused by the primary tumour
• People who are considered at high risk of developing a fistula in the oesophagus, or who show signs of a hole forming in the oesophagus
• People who have previously had surgery for oesophageal cancer
• People who are significantly malnourished, with a body mass index below 18.5, or a high score on a nutritional assessment tool (confirm with trial site)
• People who have uncontrolled fluid build-up around the lungs, heart, or abdomen that has needed repeated draining or medical treatment within the 2 weeks before joining
• People who are known to be unable to tolerate or have not responded to the chemotherapy drugs specified in this study
• People who have already received any cancer treatment for this oesophageal cancer, including immunotherapy drugs targeting certain proteins (PD-1, PD-L1, PD-L2), radiotherapy, targeted therapy, ablation, or other systemic or local treatments
• People with an active autoimmune disease, or a history of autoimmune disease that may come back — although some conditions such as controlled type 1 diabetes, hypothyroidism managed with hormone replacement, controlled coeliac disease, or certain skin conditions not needing systemic treatment may still be eligible (confirm with trial site)
• People who have had another active cancer within the past 2 years, other than certain skin cancers or early-stage cancers that have been fully treated and cured
• People who have needed regular steroid tablets or injections at doses above a low threshold, or other immune-suppressing medicines, within the 14 days before joining — although low-dose steroids, topical or inhaled steroids, or short-term steroid use for specific reasons may be acceptable (confirm with trial site)
• People with uncontrolled diabetes, certain significant abnormalities in potassium or sodium blood levels, or severely low blood protein levels within 14 days before joining
• People with a history of interstitial lung disease, non-infectious lung inflammation, or uncontrolled conditions such as pulmonary fibrosis or acute lung disease
• People with a serious ongoing infection requiring antibiotic, antifungal, or antiviral treatment within 14 days before joining — although people with chronic hepatitis B or C who are receiving antiviral therapy are permitted
• People with a known history of HIV infection
• People who have had major surgery within 28 days before joining (minor procedures such as a PICC line insertion are not considered major surgery)
• People who have previously had a stem cell transplant from a donor, or an organ transplant
• People with certain serious heart or blood vessel conditions, including: chest pain limiting daily activities within the past 28 days; a blood clot in the lungs within the past 28 days; a heart attack within the past 6 months; severe heart failure within the past 6 months; significant irregular heart rhythms within the past 6 months; a stroke within the past 6 months; blood pressure that remains very high despite medication within the past 28 days; or fainting or seizures within the past 28 days
• People with a history of a severe allergic reaction to monoclonal antibody medicines, or to cisplatin or paclitaxel (chemotherapy drugs used in this trial)
• People who have received chemotherapy, immunotherapy, or any experimental treatment within 14 days or 5 half-lives (whichever is longer) before the first study dose
• People who have used herbal medicines intended to control cancer within 14 days before the first study dose
• People who still have significant side effects from a previous cancer treatment that have not returned to a stable level
• People who have received a live vaccine within 28 days before joining — inactivated flu vaccines are generally permitted, but nasal spray flu vaccines are not
• People with underlying health conditions, abnormal test results, or alcohol or substance use issues that could interfere with the study treatment or make it difficult to follow the study's requirements
• People who are currently participating in another treatment clinical trial
• People who, in the investigator's judgement, should not participate — for example, people who are imprisoned or involuntarily detained

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