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Mini tumors in a dish could pick the right drug for stubborn cancers

NCT ID NCT05267912

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether growing a patient's tumor cells in the lab (as 3D 'organoids') can help doctors pick the best drug for advanced cancers that have stopped responding to standard treatments. About 152 adults with colorectal or pancreatic cancer will have a biopsy to create these organoids, which are then exposed to a panel of drugs to see which ones work. The goal is to see if this personalized approach is feasible and can improve how long patients live without their cancer growing.

What this could mean

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

Active substance
tumor organoid-based chemogram (lab test on biopsy sample)
What this could lead to
If successful, this could help doctors choose more effective drugs for patients with advanced cancers that have stopped responding to standard treatments.
What could go wrong
This is an early feasibility study, not a treatment trial. The organoid test may not always predict real patient responses, and results may not lead to better outcomes for everyone.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 152 people

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

Started

Jan 2022

Expected to finish

Jan 2029

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: * Age ≥18 years * ECOG performance status 0-1 * Life expectancy \>3 months * Histologically-confirmed, unresectable, locally advanced or metastatic solid tumor * ORGANOTREAT-01: CRC * ORGANOTREAT-02A: Colorectal adenocarcinoma (CRC) or pancreatic ductal adenocarcinoma (PDAC) * ORGANOTREAT-02B: solid cancers with a PDO take-on rate ≥50%: * Stratum 1: PDAC * Stratum 2: CRC * Other strata: to be added by protocol amendment * ≥1 measurable lesion according to RECIST v1.1 * ≥1 tumor site accessible to biopsy without significant risk, outside from lung lesion * Patients are to be biopsied before the start or within the 3 first weeks of the SoC line. * Failure (disease progression or intolerance) or contraindication to validated treatments in the advanced setting; patients MUST be still eligible for at least 1 (ORGANOTREAT-01 and -2A) or 2 (ORGANOTREAT-02B) validated systemic treatment lines according to approved guidelines: * CRC (ORGANOTREAT-01): failure (disease progression or intolerance) or contraindication to fluoropyrimidines, oxaliplatin, irinotecan, anti-EGFR (in RAS wild-type tumors), anti-BRAF (in BRAF V600E mutated tumors), and antiangiogenics; patients must be still eligible for trifluridine-tipiracil and/or regorafenib * CRC (ORGANOTREAT-2A): failure (disease progression or intolerance) or contraindication to fluoropyrimidines, oxaliplatin, irinotecan, anti-EGFR (in RAS wild-type tumors), anti-BRAF (in BRAF V600E mutated tumors), and trifluridine-tipiracil/bevacizumab; patients must be still eligible for regorafenib * PDAC (ORGANOTREAT-2A): Patients will be included at the beginning of their second line of standard therapy * PDAC (ORGANOTREAT-02B stratum 1): patients will be included at the beginning of their first- or second-line of therapy * Specifications for supplementary tumor strata in ORGANOTREAT-02 will be defined by protocol amendment * Adequate hepatic, renal and hematological functions (AST/ALT \< 2.5 ULN (5 ULN in cases of liver metastases); Total bilirubin \< 1.5 ULN; Albumin \> 30 g/L; International normalized ratio (INR) \<1.5 ULN; Calculated creatinine clearance \>50 mL/min; Absolute neutrophil count \>1000/mm3, platelets \>100 000/mm3, hemoglobin \>9 g/dL) To be performed until 7 days before enrollment * Informed consent signed by the patient or his/her legal representative * Affiliation to or beneficiary of a social security system * A female participant is eligible to participate if she is not pregnant not breastfeeding, and 1. Not a woman of childbearing potential (WOCBP) OR 2. A WOCBP should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * A WOCBP must agree to follow the contraceptive guidance or abstain from heterosexual activity during the treatment period and for at least 180 days, after the last dose of treatment. Exclusion Criteria: * History of other invasive cancer within 5 years prior to entry into the trial other than adequately treated basal-cell skin cancer or in situ carcinoma of the cervix * Concomitant medications/comorbidities that may prevent the patient from being biopsied * Patients with brain or meningeal metastasis, unless definitive therapy occurred more than 6 months ago and with a confirmation of tumoral control and absence of symptoms within 4 weeks of starting study treatment * Pregnancy or breast-feeding * Privation of liberty or guardianship * Geographical, social or psychological reasons precluding study participation and monitoring * Coagulation abnormality prohibiting a biopsy

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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

    10 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

  • CHU de Poitiers

    NOT_YET_RECRUITING

    Poitiers, France, 86000, France

  • Centre Eugène Marquis

    RECRUITING

    Rennes, France, 35000, France

  • Centre Léon Bérard

    ACTIVE_NOT_RECRUITING

    Lyon, France, 69008, France

  • Centre Oscar Lambret

    RECRUITING

    Lille, France, 59000, France

  • Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • HIA Bégin

    RECRUITING

    Saint-Mandé, France, 94160, France

  • Hôpital Pitié-Salpêtrière

    RECRUITING

    Paris, France, 75013, France

  • Hôpital Saint Louis

    RECRUITING

    Paris, France, 75010, France

  • Hôpital St Antoine

    RECRUITING

    Paris, France, 75571, France

  • Institut Bergonié

    RECRUITING

    Bordeaux, France, 33000, France

  • Institut Godinot

    RECRUITING

    Reims, France, 51726, France

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