Phase 2 Stomach 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:

• Adults aged 18 or older
• People who have been diagnosed with advanced or metastatic stomach cancer confirmed by a tissue biopsy, where the cancer does not show liver-like cell features, tests negative for a protein called HER-2, and has a blood protein level (AFP) of 20 ng/ml or higher
• People who have not yet received any systemic (whole-body) drug treatment for their advanced cancer
• People whose cancer has at least one measurable tumour or spread that can be tracked using standard imaging guidelines (RECIST v1.1)
• People with a good general health and activity level, rated 0 or 1 on a standard medical scale (ECOG), meaning fully active or able to carry out light activity
• People whose blood counts, liver function, kidney function, and blood clotting results fall within the acceptable ranges specified by the trial (confirm with trial site for exact values)
• People whose urine protein levels fall within acceptable limits as measured by one of three standard testing methods (confirm with trial site)
• People who have recovered from any side effects of previous chemotherapy, radiotherapy, or surgery to a mild level or better before starting the trial
• Women who could become pregnant must have a negative pregnancy test within 14 days before joining, and both male and female participants must agree to use suitable contraception from the first treatment until 120 days after the last treatment
• People who are able to swallow and take oral (by mouth) medications
• People who have read and signed the informed consent form

Who may not be able to join:

• People who had surgery or radiotherapy within 2 weeks before joining the trial
• People who have previously been treated with a drug called Lenvatinib, or any drug that targets PD-1, PD-L1, or PD-L2 (a type of immune therapy)
• People with high blood pressure that cannot be controlled with medication (systolic pressure of 160 mmHg or higher, or diastolic pressure of 90 mmHg or higher)
• People who had a heart procedure called coronary angioplasty, or experienced a heart attack or unstable chest pain, within the 6 months before joining
• People who have brain metastases (cancer that has spread to the brain) that are causing symptoms
• People who have had moderate-to-severe heart failure or serious heart rhythm problems within the past 6 months
• People who have had another active cancer diagnosed within the past 24 months, with some exceptions such as certain skin cancers or early-stage cervical changes (confirm with trial site)
• People who have serious complications requiring hospitalisation
• People who have had a tear or abnormal opening in the stomach or intestines (perforation or fistula) within the past 6 months
• People with an active hepatitis infection
• People with a history of HIV infection
• People who have active symptoms or signs of a lung condition called interstitial lung disease
• People who have an autoimmune disease, or a history of a long-term or recurring autoimmune condition
• People who need ongoing treatment with steroid medicines or immune-suppressing drugs, or who have received such treatment within 14 days before joining (certain short-term or preventive uses may be exceptions — confirm with trial site)
• People who have a history of non-infectious lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonia
• People who received a live vaccine within 30 days before starting the trial treatment
• People who have serious wounds, ulcers, or bone fractures that have not healed
• Women who are pregnant or breastfeeding
• People whom the trial investigators consider unsuitable for participation for medical or other reasons

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