Investigator-initiated Clinical Trial of MIKE-1

Exclusion Criteria

• •1. Patients with any of the following complications Patients with poorly controlled heart disease (congestive heart failure, myocardial infarction, or unstable angina within 1 year before enrollment, arrhythmia requiring treatment, etc.) Poorly controlled diabetes or hypertension Active autoimmune disease requiring systemic administration of steroids or immunosuppression therapy Interstitial pneumonia or pulmonary fibrosis (patients with current grade 2 or higher)
• •2. Patients who have received other clinical trial drugs or products (excluding existing chemotherapeutic agents and placebo drugs) within 4 weeks before enrolment.
• •3. Patients with confirmed brain metastasis (confirmed by head CT or MRI if the patient has symptoms of brain metastasis)
• •4. Patients with ascites or pleural effusion requiring drainage.
• •5. Patients who fall under any of the following HBs antigen positive HCV antibody positive and HCV-RNA positive HIV antibody positive
• •6. Patients with Grade 2 or higher peripheral sensory or motor neuropathy
• •7. Patients with multiple cancers (multiple cancers are defined as simultaneous multiple cancers and metachronous multiple cancers with disease-free survival of 5 years or less. lesions equivalent to carcinoma in situ or intramucosal carcinoma that are considered curable by local treatment are not included in multiple cancers)
• •8. Patients who have undergone surgery (excluding diagnostic biopsy and review laparoscopy) within 4 weeks before enrollment.
• •9. Patients with bleeding disorders or coagulation disorders that preclude the safe biopsy under EUS (e.g., significant intratumoral bleeding, coagulation disorders, history of bleeding disorders, or complications).
• •10. Patients with a history of allergy to the trial drug, combination chemotherapy, its additives, or vitamin A products.
• •11. Patients requiring anticoagulant medication.
• •12. Patients with cerebral infarction, pulmonary infarction, other arterial or venous thrombosis or its sequelae with clinical symptoms.
• •13. Patients with gastrointestinal disorders that may affect the absorption of the investigational drug.
• •14. Female patients who are pregnant or breastfeeding (unless breastfeeding is discontinued and not resumed).
• •15. Male patients whose sex partner is a woman who wishes to become pregnant.
• •16. Patients with vitamin A overload.
• •17. Patients receiving vitamin A preparations or regularly using vitamin A-containing supplements (patients can be enrolled if the administration is discontinued at the time of obtaining consent).
• •18. Other patients deemed inappropriate by the investigator or sub-investigator.