Investigator-initiated Clinical Trial of MIKE-1
Trial Parameters
Brief Summary
To evaluate the safety and tolerability of Am80（Generic name: Tamibarotene, Development code: MIKE-1） in combination with gemcitabine (GEM) and nab-paclitaxel (nab-PTX) in patients with unresectable pancreatic cancer and to determine the recommended dose. Efficacy will also be exploratively investigated.
Eligibility Criteria
* Inclusion Criteria: \- Patients who meet all of the following criteria will be eligible for this study. Besides, CTCAE v5.0 will be used to determine the grade of adverse events in this study. 1. Patients with unresectable pancreatic cancer who are histologically or cytologically diagnosed as adenocarcinoma based on the 7th edition of the Pancreatic Cancer Treatment Protocol and meet the following criteria. Patients who have not received any anticancer therapy (radiation therapy, chemotherapy, immunotherapy, surgery, or investigational therapy) for this disease. 2. Patients who are between 20 and 79 years of age at the time of consent. 3. Patients with at least one measurable lesion based on RECIST ver 1.1 in the primary pancreatic lesion confirmed by contrast-enhanced CT at the screening. 4. Patients who are expected to survive for at least 12 weeks after the start of treatment. 5. Patients who can understand the contents of this study and can give written consent. 6. Patients with