Testing a new four-drug combination for advanced stomach and pancreatic cancers

Plain-English translation of NCT04361708 on ClinicalTrials.gov ↗ · Source last updated October 2025 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This trial is testing a new chemotherapy combination called gFOLFOXIRITAX, which combines with three other cancer-fighting drugs (fluorouracil, , , and ). The study is designed to find the safest dose of this medication combination and learn how well it works for people with advanced cancers of the upper digestive system, including the pancreas and stomach. Your genetic test results will help doctors determine the right dose for you.

Currently, there is no standard treatment that combines all four of these drugs together for these types of advanced cancers. This study aims to see if this medication combination is safe enough and effective enough to help patients whose cancers have already spread or cannot be removed with surgery.

Do you qualify?

You likely qualify if…

you have been diagnosed with advanced pancreatic cancer, stomach cancer, or other upper digestive tract cancers that cannot be surgically removed
you have not received any chemotherapy for advanced disease (though prior surgery or radiation may disqualify you)
you are at least 18 years old and able to care for yourself with minimal assistance
you have adequate organ function, including normal blood cell counts, kidney function, and liver function
your life expectancy is more than three months

You likely don't qualify if…

you have received prior radiation therapy or chemotherapy for metastatic (spread) cancer
you have inflammatory bowel disease such as Crohn's disease or ulcerative colitis
you currently have diarrhea or nerve damage from prior treatments
you have brain metastases (cancer that has spread to your brain)
you are pregnant, breastfeeding, or unwilling to use effective contraception during and for three months after treatment

What participation looks like

You will first have a genetic test to determine your UGT1A1 status, which will guide your personalized dose. Then you will receive the four-drug chemotherapy combination through intravenous infusion, likely in repeating cycles over several weeks or months. You will have regular visits for blood tests, imaging scans, and check-ins with your care team to monitor how well the treatment is working and watch for side effects. The exact duration and schedule will depend on how well you tolerate the medication and how your cancer responds.

AI-generated summary from trial data · Jun 30, 2026 · Not medical advice

Trial locations(1 site)

United States

The University of Chicago, Chicago, Illinois