Status:
ACTIVE_NOT_RECRUITING
Prospective Multicenter Study Evaluating Feasibility and Efficacy of Tumor Organoid-based Precision Medicine in Patients With Advanced Refractory Cancers
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Advanced, Pretreated Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
* PDOs are tridimensional multicellular structures expanded in vitro which retain the genotypic and phenotypic features of their tissue or tumor of origin. PDOs can be exposed to a panel of drugs (che...
Detailed Description
ORGANOTREAT-01, -02A and -02B * Patients with advanced, pretreated solid cancers will be enrolled at the beginning of a standard-of-care (SoC) treatment line to allow sufficient time for PDO (tumor-d...
Eligibility Criteria
Inclusion
- 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
- Not a woman of childbearing potential (WOCBP) OR
- 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
- 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
Key Trial Info
Start Date :
January 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 18 2029
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT05267912
Start Date
January 19 2022
End Date
January 18 2029
Last Update
December 16 2025
Active Locations (8)
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1
Institut Bergonié
Bordeaux, France, France, 33000
2
Centre Oscar Lambret
Lille, France, France, 59000
3
Centre Léon Bérard
Lyon, France, France, 69008
4
Hôpital Saint Louis
Paris, France, France, 75010