Mini-Tumors grown in a dish could guide chemo choices for advanced colorectal cancer

NCT ID NCT06907342

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This study tests whether a lab-grown mini-tumor (tumouroid) from a patient's biopsy can help doctors pick the more effective chemotherapy between two standard options (FOLFOX or FOLFIRI) for metastatic colorectal cancer. The trial enrolls adults with a specific type of colorectal cancer that has spread and cannot be surgically removed. The main goal is to see if the tumouroid test can be completed quickly enough to guide first-line treatment.

What this could mean

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

Active substance
a lab-grown mini-tumor (tumouroid) test that guides whether to use FOLFOX or FOLFIRI chemotherapy
What this could lead to
If successful, this approach could make chemotherapy more effective and reduce side effects by matching each patient to the drug that works best for their unique tumor.
What could go wrong
This is a small, early feasibility study, so the test may not reliably predict which drug works best, and the approach may not improve outcomes compared to standard care.

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 148 people

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

Started

May 2025

Expected to finish

Sep 2040

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: General conditions: 1. Age 18 or older 2. ECOG performance status 0 or 1 3. Obtained informed consent 4. Acceptable organ function (defined in publicly available protocol) 5. Women of child-bearing potential and men must agree to use highly effective contraception (defined in publicly available protocol) Disease and treatment specific conditions: 6. Histologically confirmed pMMR/MSS adenocarcinoma originating from the colon or rectum 7. Unresectable metastatic disease (not amenable to radical surgery of the cancer disease at the time of study inclusion) 8. Patient has metastatic or primary lesion available for biopsy 9. Patient has measurable or evaluable disease per RECIST (version 1.1) 10. The oxaliplatin-based regimen FOLFOX (+/- antibody) versus the irinotecan-based regimen FOLFIRI (+/- antibody), are evaluated by an experienced physician, independent of inclusion in the trial, to be equally recommended for the participant as standard of care first-line therapy in the treatment of mCRC, following the Norwegian national guideline on the treatment of colorectal cancer (https://www.helsedirektoratet.no/retningslinjer/kreft-i-tykktarm-og-endetarm-handlingsprogram) 11. Patient is eligible for full (100%) chemotherapy doses at first treatment cycle 12. Treatment with chemotherapy can be scheduled within 28 days from referral Exclusion Criteria: 1. Patient has metastatic MMR deficient/MSI adenocarcinoma 2. Patient is ineligible for full (100%) chemotherapy doses at first treatment cycle 3. Patient is not equally eligible for FOLFOX (+/- antibody) and FOLFIRI (+/- antibody) chemotherapy regimens, according to the Norwegian national guideline on the treatment of colorectal cancer 4. ECOG performance status 2 or worse 5. Pregnancy or planned pregnancy during the study period, due to the risks of drug treatment to a developing foetus 6. Breastfeeding 7. Patients with psychological, geographical, familial or sociological conditions that can prevent compliance with the study protocol 8. Inability to understand study procedures and comply with them, or disorder that compromises the patient's ability to provide informed consent and/or comply with study procedures 9. Patient fulfils any of the contraindications listed in the SmPC of the relevant IMP 10. Treatment cannot be scheduled within 28 days from referral Medical history: 11. Partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency 12. Evidence of CNS metastasis 13. Unresolved toxicities of a previous systemic treatment that, in the opinion of the physician, make the patient unfit for inclusion 14. Antitumoural treatment ≤ 30 days before inclusion. Hormonal substitutive treatment is allowed 15. Preexisting significant cardiovascular disease including uncontrolled/unstable or symptomatic angina, uncontrolled atrial or ventricular arrythmias, LVEF known to be \< 40% or symptomatic congestive heart failure 16. Stroke (including TIA) or acute myocardial infarction within 6 months before the first dose of study treatment 17. Clinically significant peripheral sensory neuropathy 18. Recent (\<6 months before the start of study treatment) pulmonary embolism, deep vein thrombosis, or another significant thromboembolic event 19. History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on chest computed tomography (CT) 20. Evidence of previous acute hypersensitivity reaction to any component of the treatment 21. History of any disease that may increase the risks associated with study participation

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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

    1 site. 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

  • St. Olavs Hospital

    RECRUITING

    Trondheim, Norway

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