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New hope for advanced colon cancer: drug combo trial launches

NCT ID NCT07011576

Disease control Sponsor: SCRI Development Innovations, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 study tests a combination of two drugs (fruquintinib and FOLFIRI) in people with advanced colorectal cancer that has spread. It is for those who have already had one prior treatment. The goal is to see if this new combination can help control the cancer longer and with manageable side effects. About 60 adults will take part.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jun 2027

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.

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.

Key Inclusion Criteria: * Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1. * Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600 * Participants must have received first-line therapy for mCRC that included oxaliplatin, a fluoropyrimidine, and a BEV-based agent. FOLFOXIRI, BEV, and SOX/BEV regimes are not permitted. A minimum of 2 cycles of first line of therapy must have been completed. * At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF) * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2 Key Exclusion Criteria: * Current treatment with other anticancer treatments within 21 days of the first dose of study treatment * Major surgery within 4 weeks of the first planned dose of study treatment * More than one prior systemic treatment for mCRC or any prior systemic treatment including FOLFIRI or irinotecan-based therapy. * Participants who received oxaliplatin and fluoropyrimidine in the first line neoadjuvant or adjuvant setting (prior to Metastatic diagnosis) and progressed within 6 months are not eligible due to lack of BEV exposure. * Uncontrolled, symptomatic brain metastases * Uncontrolled, symptomatic gastrointestinal disease * Participants with uncontrolled hypertension * Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 6 months after the last administration of study chemotherapy * Men who plan to father a child while in the study and for at least 6 months after the last administration of study chemotherapy * Documented major electrocardiogram (ECG) abnormalities which are clinically significant. * Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment * Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening

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Conditions

The condition(s) this trial relates to.

colon carcinoma colonic neoplasm colorectal cancer colorectal neoplasm rectal cancer rectal neoplasm

As listed by the trial registrant

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

Colon cancer Colorectal cancer Colorectal cancer (CRC) Rectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alliance Cancer Specialists

    RECRUITING

    Wynnewood, Pennsylvania, 19096, United States

  • Blue Ridge Cancer Care (Oncology & Hematology Associates of Southwest VA)

    RECRUITING

    Salem, Virginia, 24153, United States

  • Illinois Cancer Specialists

    RECRUITING

    Arlington Heights, Illinois, 60005, United States

  • Maryland Oncology Hematology

    RECRUITING

    Columbia, Maryland, 21044, United States

  • Minnesota Oncology Hematology - Primary

    RECRUITING

    Maple Grove, Minnesota, 55369, United States

  • Missouri Cancer Associates

    RECRUITING

    Columbia, Missouri, 65201, United States

  • Northwest Cancer Specialists - Compass

    RECRUITING

    Portland, Oregon, 97213, United States

  • Oncology Associates of Oregon - Primary

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Rocky Mountain Cancer Center - Primary

    RECRUITING

    Denver, Colorado, 80218, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Texas Oncology - Central/South Texas

    RECRUITING

    Austin, Texas, 78705, United States

  • Texas Oncology - Gulf Coast

    RECRUITING

    Beaumont, Texas, 77702, United States

  • Texas Oncology - Northeast Texas

    RECRUITING

    Tyler, Texas, 75702, United States

  • Virginia Oncology Associates

    RECRUITING

    Norfolk, Virginia, 23502, United States

More trials for these conditions

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