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Which drug first? Real-World study aims to optimize colorectal cancer treatment sequence

NCT ID NCT05839951

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

818 people

The number who actually took part.

Started

Apr 2023

Finished

Apr 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.