* 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 (chemotherapy, hormonal therapy, targeted therapy) in order to study their sensitivity to each agent (or combination of agents) tested ('chemogram'). Recent studies showed that PDOs can accurately predict the response to treatment of solid tumors and could therefore inform clinical decision on the best therapeutic option for each patient. * ORGANOTREAT is a multicenter prospective study program of organoid-based precision oncology encompassing 3 studies: ORGANOTREAT-01, a pilot study restricted to advanced CRC, and ORGANOTREAT-02A and -2B, two Phase 2 studies in advanced solid cancers.
Age ≥18 years
ECOG performance status 0-1
Life expectancy >3 months
Histologically-confirmed, unresectable, locally advanced or metastatic solid tumor
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
Parallel
Biopsy
Procedure/SurgeryWe need a biopsy for PDO: 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 (chemotherapy, hormonal therapy, targeted therapy) in order to study their sensitivity to each agent (or combination of agents) tested ('chemogram'). Recent studies showed that PDOs can accurately predict the response to treatment of solid tumors and could therefore inform clinical decision on the best therapeutic option for each patient.
ORGANOTREAT-01: Chemogram
number of patients for whom a PDO-based chemogram is obtained within 10 weeks after biopsy
ORGANOTREAT-02A: Proportion of patients treated according to the chemogram tumor board (CTB)'s recommendations on the basis of their personalized chemogram.
Proportion of patients treated according to the chemogram tumor board (CTB)'s recommendations on the basis of their personalized chemogram.
ORGANOTREAT-02B: PFS
progression free survival
ORGANOTREAT-02A and -02B: chemogram
proportion of patients for whom a PDO-based chemogram is obtained within 10 weeks after biopsy,
ORGANOTREAT-01 and -02A: PFS
progression free survival
ORGANOTREAT-01, -02A and -02B: GMI
Growth Modulation Index
ORGANOTREAT-01, -02A and -02B: ORR
Overall Response Rate
Click on the lead sponsor to view all of their trials.
