This clinical study is testing a new combination of cancer drugs called TAS-102 and nanoliposomal irinotecan (nal-IRI) to treat advanced gastrointestinal (GI) cancers that have spread or cannot be removed by surgery. TAS-102 is a mix of two medicines, trifluridine and tipiracil hydrochloride, which help stop cancer cells from growing. Irinotecan is a drug wrapped in tiny fat bubbles (nanoliposomes) to help it reach cancer cells better. This study is in two parts: Phase I to find the best dose, and Phase II to see how well it works. Patients will take TAS-102 pills twice a day for 5 days and get irinotecan through an IV for 90 minutes on day 1, repeating every 2 weeks. The study will also check for side effects and how long the treatment works. After the treatment, patients will be followed up for 30 days, then every 8 to 12 weeks.
- Study lasts several months with regular doctor visits.
- Patients must have specific types of GI cancer and meet health criteria.
- Potential side effects and risks will be monitored closely.