Testing a new medication as a second treatment for advanced bowel cancer

Plain-English translation of NCT07213570 on ClinicalTrials.gov ↗ · Source last updated December 2025 · Translation generated August 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing whether a medication called regorafenib can help people with advanced bowel cancer after their first treatment stops working. You would be randomly assigned to either take regorafenib or receive standard second-line treatment. The study will track how well the medication works and what side effects people experience over time.

After first-line chemotherapy, people with advanced bowel cancer need a second treatment option. This medication may offer a new choice for patients whose cancer has a specific genetic mutation, potentially improving outcomes when standard treatments are not enough.

Do you qualify?

You likely qualify if…

you have been diagnosed with metastatic (advanced, spread-throughout-the-body) bowel cancer with a specific RAS gene mutation
your cancer progressed after at least 6 months of first-line chemotherapy, or you have only one area where cancer has spread
you are at least 18 years old and in reasonably good overall health (ECOG score of 0–1)
your blood counts, liver function, and kidney function are within acceptable ranges based on recent blood tests
you have a life expectancy of more than 12 weeks

You likely don't qualify if…

you have had another cancer diagnosis in the past 5 years (except skin cancers or cervical cancer in situ)
you have had brain metastases (cancer that has spread to the brain)
you are pregnant, breastfeeding, or unwilling to use contraception during the study and for 6 months after
you have had major surgery within the past 4 weeks
you have a complete deficiency of a specific enzyme (DPYD) that processes certain cancer medications

What participation looks like

You would visit the clinic regularly for blood tests, physical exams, and imaging scans (CT or MRI) every 8 weeks to monitor your cancer. If randomized to the medication arm, you would take regorafenib orally (by mouth) daily, with the dose gradually increased over the first month based on how well you tolerate it. You would continue treatment until your cancer progresses, side effects become too severe, or you decide to stop—and you would be followed long-term to track your health and any additional treatments you receive.

AI-generated summary from trial data · Aug 2, 2026 · Not medical advice

Trial locations(1 site)

Italy

Istituto Nazionale Tumori | "Fondazione Pascale", Naples, Italy