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:

• People diagnosed with a specific type of aggressive, poorly differentiated (Grade 3) neuroendocrine carcinoma, or a mixed tumour where at least 30% is this type, originating from the digestive system, pancreas, or of unknown origin
• People whose cancer has spread to other parts of the body (metastatic disease)
• People who have not yet received any treatment for their metastatic disease, and have never been treated with specific chemotherapy drugs including carboplatin, oxaliplatin, cisplatin, etoposide, irinotecan, or 5-fluorouracil
• People who have at least one tumour that can be measured on a CT scan or MRI
• People for whom a stored tumour tissue sample is available
• People whose blood test results meet specific thresholds for white blood cells, platelets, haemoglobin, liver function, and bilirubin levels (confirm with trial site)
• People aged 18 years or older
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale called the ECOG Performance Status (confirm with trial site)
• People who are willing and able to follow the trial requirements and have signed a consent form
• Women who could become pregnant, and men who have sexual relations with women who could become pregnant, must agree to use effective contraception throughout the trial and for 15 months after the last dose
• People who are enrolled in the French Social Security system

Who may not be able to join:

• People whose tumour is classified as a well-differentiated Grade 3 neuroendocrine tumour according to a specific 2017 classification system
• People with severely reduced kidney function (confirmed by a specific kidney function measurement)
• People with a complete or partial deficiency of an enzyme called DPD, which affects how certain chemotherapy drugs are processed by the body
• People with a condition called Gilbert's syndrome, which affects how the liver processes a substance called bilirubin
• People with pre-existing significant nerve damage (neuropathy rated Grade 2 or higher)
• People who have previously received chemotherapy or targeted therapy treatments
• People with brain metastases, unless those metastases are not causing symptoms or have been stable on a consistent steroid dose for at least two weeks; if symptoms are present, radiation therapy before joining the trial is required
• People currently taking a medication called sorivudine or similar drugs such as brivudine
• People currently using St John's Wort (a herbal supplement)
• People who are pregnant or breastfeeding
• People with a known or past active HIV infection, or an untreated active hepatitis B or hepatitis C infection
• People with a history of another cancer, unless it was a treated non-melanoma skin cancer, treated cervical cancer in situ, or another cancer that has shown no signs of returning for at least three years
• People with an active or uncontrolled serious medical condition that the trial doctor considers would make participation unsafe or inappropriate
• People who have received a live vaccine within 30 days before starting the trial
• People under legal guardianship or who are legally detained
• People whose heart rhythm measurement (ECG) shows a QT/QTc interval above 450 milliseconds (for men) or 470 milliseconds (for women)
• People whose blood levels of potassium, magnesium, or calcium are below the normal range
• People with a known allergy or sensitivity to any of the chemotherapy drugs used in the trial or their ingredients

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