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Can a Two-Drug combo outsmart resistant colorectal cancer?

NCT ID NCT06221423

Disease control Sponsor: Fudan University Source: ClinicalTrials.gov ↗

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial is testing whether combining two standard drugs—fruquintinib and TAS-102—can help people with metastatic colorectal cancer that has stopped responding to at least two prior chemotherapy regimens. The study will measure how long patients live without the disease getting worse and overall survival. Participants are adults aged 18 to 75 with confirmed metastatic colorectal cancer who are eligible for salvage treatment with fruquintinib.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fruquintinib combined with TAS-102 (trifluridine/tipiracil)
What this could lead to
If the combination works, it could offer a new treatment option to extend survival for people with advanced colorectal cancer who have run out of standard options.
What could go wrong
This is an early, single-center study with no results yet. The combination may not improve outcomes and could increase side effects compared to either drug alone.

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.

Expected to start

Jan 2020

An estimate. Start dates often move.

Expected to finish

May 2024

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 refractory metastatic colorectal cancer who have undergone third-line or later treatment with a combination of fruquintinib and TAS-102.

Ages

18 to 75 years

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: * Histology-confirmed metastatic CRC (mCRC) * Disease progression on standard therapy with at least two lines of chemotherapy, including fluorouracil, oxaliplatin, and irinotecan with or without biologics such as bevacizumab and cetuximab * Fruquintinib administered as salvage treatment * Age: 18-75 years old * Informed consent Exclusion Criteria: * Liver or kidney dysfunction, or other conditions unsuitable for chemotherapy * Fruquintinib and/or TAS-102 administration as second-line treatment * Drug administration stopped after less than two cycles

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer Metastatic colorectal cancer Refractory colorectal carcinoma

Contacts and locations

Locations

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

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