TAS102 and NAL-IRI Study for Advanced GI Cancers

This study is testing a new drug combination to treat advanced gastrointestinal (GI) cancers. These cancers have either spread to other parts of the body (called metastatic) or cannot be removed by surgery. The study includes two drugs: TAS-102 (trifluridine/tipiracil hydrochloride) and NAL-IRI (nanoliposomal irinotecan). TAS-102 helps stop cancer cells from growing and spreading, while NAL-IRI works to kill the cancer cells.

• This study involves taking TAS-102 pills twice daily and receiving NAL-IRI through a vein every two weeks.
• Participants need to already have received some treatment for their cancer but can still join if the cancer has gotten worse.
• After the initial treatment, patients are monitored for up to 12 weeks.

Participants must have advanced cancer confirmed by tests, be able to take oral medications, and meet specific health requirements. They should not have had previous treatment with irinotecan for the second phase of the study. People with certain health conditions or history, like severe heart problems, or who are pregnant or breastfeeding, cannot join. The study will help find the best dose and check how well the drugs work together.