NCT05267912

Prospective Multicenter Study Evaluating Feasibility and Efficacy of Tumor Organoid-based Precision Medicine in Patients With Advanced Refractory Cancers

Prospective Multicenter Study Evaluating the Feasibility and Efficacy of Tumor Organoid-based Precision Medicine in Patients With Advanced Refractory Cancers

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (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.

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-derived organoid) generation and chemogram. * A biopsy of an easily accessible tumor site will be performed. * PDO generation, culture and amplification and drug testing will be performed. * A chemogram report will be prepared. * The CTB (Chemogram Tumor Board) will make treatment recommendations based on the chemogram report. * Patients enrolled in ORGANOTREAT-01, ORGANOTREAT-02A and in the experimental arm of ORGANOTREAT-02B will be treated according to the CTB's recommendations after disease progression or unacceptable toxicity while on SoC. * Patients will be treated at the investigator's discretion until disease progression or unacceptable toxicities. Patient will be followed until death or study termination, whichever occurs first . Note : Provide, as long as necessary (without time limit) the treatments to patient is agreed by all the centers. * Patients for whom no chemogram can be obtained will be treated according to Soc

Conditions

• Advanced, Pretreated Solid Tumors

Interventions

Type	Name	Description
PROCEDURE	Biopsy	We 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.

Timeline

• Start date: 2022-01-19
• Primary completion: 2028-01-18
• Completion: 2029-01-18
• First posted: 2022-03-07
• Last updated: 2025-12-16

Locations

8 sites across 1 country: France