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

NCT05267912 | Active Not Recruiting

• 2 other identifiers: 2021-A00939-322021/3270
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 8

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 (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.

Conditions

Advanced, Pretreated Solid Tumors

Outcome Measures

Primary Outcomes (3)

• ORGANOTREAT-01: Chemogram

  number of patients for whom a PDO-based chemogram is obtained within 10 weeks after biopsy

  30 months

• 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.

  48 months

• ORGANOTREAT-02B: PFS

  progression free survival

  36 months

Secondary Outcomes (10)

• ORGANOTREAT-02A and -02B: chemogram

  36 months

• ORGANOTREAT-01 and -02A: PFS

  36 months

• ORGANOTREAT-01, -02A and -02B: GMI

  36 months

• ORGANOTREAT-01, -02A and -02B: ORR

  36 months

• ORGANOTREAT-01, -02A and -02B: duration of response

  36 months

Study Arms (3)

ORGANOTREAT 01

EXPERIMENTAL

To assess the feasibility of timely generating chemograms from PDOs in advanced CRC. To assess the proportion of patients treated according to the chemogram tumor board (CTB)'s recommendations on the basis of their personalized chemogram. To assess the efficacy and safety of chemogram-driven treatment in advanced CRC.

Procedure: Biopsy

ORGANOTREAT 02A

EXPERIMENTAL

ORGANOTREAT-02A is a single-arm, Phase II study to evaluate the feasibility of chemogram-driven treatment in patients with advanced, pretreated solid cancers (CRC or PDAC). The primary endpoint is to assess the proportion of patients treated according to the chemogram tumor board (CTB)'s recommendations on the basis of their personalized chemogram.

Procedure: Biopsy

ORGANOTREAT 02B

EXPERIMENTAL

is a randomized Phase II study to compare the efficacy of chemogram-driven treatment vs SoC in patients with advanced, pretreated solid cancers with a PDO take-on rate ≥50%. A cross-over will allow patients enrolled in the control arm to benefit from chemogram-based treatment. Patients for whom no chemogram can be obtained will not be randomized and they will be treated according to SoC. The primary endpoint will be PFS. The study will include multiple strata, each for a different tumor type (e.g., stratum 1, pancreatic ductal adenocarcinoma (PDAC); stratum 2, CRC; etc.). Each stratum will be conducted and analyzed independently from the other strata.

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

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.

ORGANOTREAT 01; ORGANOTREAT 02A; ORGANOTREAT 02B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (8)

Institut Bergonié

Bordeaux, France, 33000, France

Location

Centre Oscar Lambret

Lille, France, 59000, France

Location

Centre Léon Bérard

Lyon, France, 69008, France

Location

Hôpital Saint Louis

Paris, France, 75010, France

Location

Hôpital Pitié-Salpêtrière

Paris, France, 75013, France

Location

Institut Godinot

Reims, France, 51726, France

Location

Centre Eugène Marquis

Rennes, France, 35000, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Fanny Jaulin, PhD

  Gustave Roussy cancer campus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * ORGANOTREAT-01: advanced, pretreated colorectal cancer (CRC). * ORGANOTREAT-02A: Advanced, pretreated colorectal cancer (CRC) or pancreatic ductal adenocarcinoma (PDAC) * ORGANOTREAT-02B: advanced, pretreated solid tumors with a PDO take-on rate ≥50%.

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 7, 2022
• Study Start: January 19, 2022
• Primary Completion (Estimated): January 18, 2028
• Study Completion (Estimated): January 18, 2029
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)