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New drug cocktail shows promise for Late-Stage colon cancer

NCT ID NCT05806931

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 new way of giving three chemotherapy drugs (TAS-102, oxaliplatin, and irinotecan) along with bevacizumab to people with advanced colorectal cancer that has stopped responding to standard treatments. The goal is to see if this approach can control the cancer and slow its growth. About 50 adults with stage IV colon or rectal cancer 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 50 people

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

Started

May 2023

Expected to finish

May 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.

Inclusion Criteria: * Histologically confirmed stage IV colon cancer (AJCC 7th edition) that has progressed after standard therapy that included 5-FU, irinotecan, oxaliplatin and appropriate antibody therapy. Antibody therapy with bevacizumab and an anti-EGFR antibody, if RAS wild type, should have been given unless medical reasons have precluded their use. Participants who could not tolerate standard agents because of unacceptable, but reversible toxicity necessitating their discontinuation will be allowed to participate. * Participants who had received adjuvant chemotherapy and had recurrence during or within six months of completion of the adjuvant chemotherapy will be allowed to count the adjuvant therapy as one chemotherapy regimen for advanced disease. * Progression of disease must be documented on the most recent scan. * Presence of measurable disease * RAS mutation and MMR status must be determined (or tissue availability for testing if not already determined). * Age 18 years or older. * ECOG performance status 0-1. * Life expectancy of at least three months. * Participants with adequate organ function: 1. Absolute neutrophil count (ANC) \> 1.5 x 109/L 2. Hemoglobin \> 9 g/dL 3. Platelets (PLT) \> 70 x 109/L 4. AST/ALT \< 5 x ULN 5. Albumin within normal limits for institution * Women who are nursing and discontinue nursing prior to enrollment in the program. * Ability to take oral medication (i.e., no feeding tube). * Participant able and willing to comply with study procedures as per protocol. * Participant able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures. Exclusion Criteria: * Participants who have previously received TAS-102. * Grade 3 or higher peripheral neuropathy (functional impairment). * Inability to tolerate irinotecan previously (due to uncontrolled diarrhea) * There are no specific exclusions for bevacizumab. Bevacizumab should be given unless there are specific contraindications per the treating investigator, which should be stated. If UPC is \>1.0 (as above) hold bevacizumab until proteinuria resolves and then start bevacizumab. * Symptomatic CNS metastases requiring treatment. * Other active malignancy within the last three years (except for non-melanoma skin cancer or a non-invasive/in situ cancer). * Pregnancy or breast feeding. * Current therapy with other investigational agents. * Active infection with body temperature \> 38°C due to infection. * Major surgery within prior four weeks (the surgical incision should be fully healed prior to drug administration). * Any anticancer therapy within prior two weeks of first dose of study drug. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS-102. * Current therapy with other investigational agents or participation in another clinical study or any investigational agent received within prior four weeks. * Grade 3 or higher hypersensitivity reaction to oxaliplatin or irinotecan, or grade 1-2 hypersensitivity reaction to oxaliplatin not controlled with pre-medication. * Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).

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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.

How to take part

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

  1. The places running it

    9 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

  • Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)

    RECRUITING

    Livingston, New Jersey, 07039, United States

  • RWJBarnabas Health - Community Medical Center

    RECRUITING

    Toms River, New Jersey, 08755, United States

  • RWJBarnabas Health - Monmouth Medical Center

    RECRUITING

    Long Branch, New Jersey, 07740, United States

  • RWJBarnabas Health - Monmouth Medical Center Southern Campus

    RECRUITING

    Lakewood, New Jersey, 08701, United States

  • RWJBarnabas Health - Robert Wood Johnson University Hospital

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • RWJBarnabas Health - Robert Wood Johnson University Hospital

    RECRUITING

    Somerset, New Jersey, 08873, United States

  • RWJBarnabas Health Jersey City Medical Center

    RECRUITING

    Jersey City, New Jersey, 07302, United States

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • Trinitas Hospital and Comprehensive Cancer Center

    RECRUITING

    Elizabeth, New Jersey, 07202, United States

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