Which drug first? Real-World study aims to optimize colorectal cancer treatment sequence
NCT ID NCT05839951
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed observational study examined the real-world use of two approved drugs, regorafenib and TAS-102 (sometimes with bevacizumab), in 818 adults with metastatic colorectal cancer that had stopped responding to other treatments. Researchers analyzed electronic health records to see how the order of these drugs affected treatment duration, side effects, and survival. The goal is to provide practical guidance for doctors on the best sequence to use in everyday practice.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Regorafenib, TAS-102 (trifluridine/tipiracil), and bevacizumab
- What this could lead to
- If successful, this study could help doctors choose the best order of these approved drugs for people with advanced colorectal cancer, potentially improving survival and quality of life.
- What could go wrong
- This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient differences and real-world variability.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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818 people
The number who actually took part.
- Started
-
Apr 2023
- Finished
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Apr 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with mCRC who received sequential treatment of Regorafenib and TAS-102 (with or without Bev), and patients with mCRC who received combo use of TAS+BEV from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cut) from Flatiron CRC EDM data (v Dec 2022 or the latest version)
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult patients who had diagnosis of mCRC (≥18 years old at diagnosis of mCRC) * Received sequential treatment of regorafenib and TAS-102 (either mono or with bevacizumab) after mCRC diagnosis, with at least one documented clinical visit on or after treatment; OR * Patients with mCRC who received combo use of TAS+BEV, with at least one documented clinical visit on or after treatment Exclusion Criteria: * Patients who had a diagnosis of gastrointestinal stromal tumors (GIST) or hepatocellular carcinoma (HCC) or other primary cancers in the baseline period (i.e., 6 months prior to index date) except non-melanoma skin cancers * Patients involved in clinical trials during the study period (as indicated by the masked therapies)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Many locations
Whippany, New Jersey, 07981, United States
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