Mini tumors in a dish could pick the right drug for stubborn cancers
NCT ID NCT05267912
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
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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
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About 152 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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CHU de Poitiers
NOT_YET_RECRUITINGPoitiers, France, 86000, France
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Centre Eugène Marquis
RECRUITINGRennes, France, 35000, France
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Centre Léon Bérard
ACTIVE_NOT_RECRUITINGLyon, France, 69008, France
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Centre Oscar Lambret
RECRUITINGLille, France, 59000, France
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Gustave Roussy
RECRUITINGVillejuif, 94805, France
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HIA Bégin
RECRUITINGSaint-Mandé, France, 94160, France
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Hôpital Pitié-Salpêtrière
RECRUITINGParis, France, 75013, France
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Hôpital Saint Louis
RECRUITINGParis, France, 75010, France
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Hôpital St Antoine
RECRUITINGParis, France, 75571, France
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Institut Bergonié
RECRUITINGBordeaux, France, 33000, France
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Institut Godinot
RECRUITINGReims, France, 51726, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a phone app help pancreatic cancer patients eat better during treatment?
- Experimental drug put to the test against Hard-to-Treat GI cancers
- Can a Dietitian's plan help older pancreatic cancer patients feel better?
- Can berry compounds tame inflammation during colorectal cancer care?
- Can a vaccine stop GI cancers from returning?