Phase 3 Stomach Cancer Trial, Completed

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:

• Adults aged 18 or older who have gastro-oesophageal cancer (starting in the stomach or the junction between the oesophagus and stomach) that has spread to other parts of the body or has come back in the local area, and where the cancer type is adenocarcinoma or undifferentiated carcinoma.
• People whose cancer can be measured on a CT scan taken within 21 days before joining the trial, following standard measurement guidelines.
• People whose cancer has stopped responding to, or who could not tolerate, at least 2 previous cancer treatments, which must have included at least one platinum-based drug and one fluoropyrimidine-based drug (confirm with trial site for details on how prior treatments are counted).
• People whose cancer tests positive for HER2 and who have previously received the drug trastuzumab.
• People who are generally well enough to carry out daily activities with little or no restriction (as measured by a standard medical scoring system called ECOG Performance Status 0 or 1).
• People who are able to swallow tablets or capsules.
• People whose blood counts, kidney function, and liver function all meet the required levels based on recent blood tests.
• People who are willing and able to follow all trial requirements, including attending appointments and completing assessments.
• People who are ready to begin the trial treatment within 7 days of being assigned to a treatment group.
• People who have read and signed a consent form agreeing to take part.

Who may not be able to join:

• People with a known allergy to regorafenib, nivolumab, or any of their ingredients.
• People with high blood pressure that is not well controlled, even with medication (above 140/90 mmHg).
• People with known gut absorption problems that are not well controlled.
• People who have previously been treated with a specific type of anti-cancer drug called a small molecule VEGF inhibitor (for example, apatinib). Note: certain other anti-VEGF drugs given as injections (such as bevacizumab or ramucirumab) are permitted.
• People who have previously received more than one type of immune checkpoint inhibitor treatment.
• People who have received any cancer drug treatment or experimental therapy within 2 weeks before the first dose of trial treatment.
• People who have received certain immune-boosting drugs (such as G-CSF) within 3 weeks before joining.
• People currently taking certain medications that strongly affect how the body processes drugs (known as strong CYP3A4 inhibitors or inducers — confirm specific medications with the trial site).
• People who have had palliative radiotherapy (radiation to ease symptoms) unless it finished more than 14 days ago and any side effects have largely settled.
• People who have had major surgery, an open biopsy, or a serious injury within 28 days before joining.
• People who have had a stroke or other arterial blood clot event within the past 6 months.
• People who have had a blood clot in a vein or lungs within the past 3 months.
• People who have had a significant bleeding episode within the past 4 weeks.
• People with a wound, ulcer, or bone fracture that has not healed.
• People with active lung inflammation (interstitial lung disease) that is causing ongoing symptoms.
• People with an actively problematic thyroid condition (overactive or underactive thyroid). Minor thyroid blood test abnormalities thought to be due to illness may be acceptable (confirm with trial site).
• People with a high level of protein in their urine (above a specified threshold on standard testing).
• People with cancer that has spread to the brain or spinal cord that is not well controlled. People with treated and stable brain metastases on a steady dose of steroids for at least 2 weeks, with no worsening symptoms, may be considered.
• People who have had another cancer diagnosis within the past 2 years. Exceptions include certain treated, low-risk cancers such as: cervical carcinoma in situ treated with curative intent; non-melanoma skin cancer; certain early-stage superficial bladder cancers; and treated papillary thyroid cancer.
• People with a serious active infection, including uncontrolled hepatitis B, hepatitis C, or HIV. People with known hepatitis B or C whose virus is well suppressed and who are on appropriate treatment may be considered.
• People who have had a recent heart attack, unstable chest pain (angina), or coronary artery procedure (such as a stent) within the past 6 months.
• People with a serious active infection meeting a particular severity level (Grade 3 or above on a standard medical scale).
• People with an active autoimmune disease, or a history of a long-term or recurring autoimmune condition.
• People who currently need regular steroid tablets or other immune-suppressing medications (except for low-dose replacement therapy or short-term use for specific purposes), or who have taken such medicines within 14 days before joining.
• People who have a seizure disorder that requires medication to control it.
• People with a serious medical or mental health condition that could affect their ability to follow the trial requirements.
• People who are pregnant, breastfeeding, or who are not using reliable contraception. Women who could become pregnant must have a negative pregnancy test within 7 days before joining. Men must either have had a surgical sterilisation procedure or use a barrier method of contraception.

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