Tailoring Treatment in Colorectal Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Akershus

About this trial

In this study, the investigators will establish a reliable method and logistic pipeline for personalized drug testing ex vivo using fresh tumor samples from colorectal cancer (CRC) patients. With this, the investigators aim to develop a novel predictive biomarker of immunotherapy response, by testing combinations of chemotherapies and chimeric antigen receptor (CAR) T cells. Critically, this affects a large subgroup of patients currently not considered to benefit from such treatment. To support the hypothesis, the project will make use of cutting-edge, cell-based functional diagnostics. Individual patients' cancer cells will be screened against a panel of chemotherapies and targeted therapies including CAR T cells, to assess the optimal combination of therapies to induce immunotherapy efficacy in otherwise unresponsive CRC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed colorectal cancer scheduled for curative surgery and standard clinical follow-up.

Disqualifiers

None

Trial population

Patients with suspected colorectal cancer referred into the program for standardized cancer diagnostic pathways at Akershus University Hospital will be offered enrolment in the study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Tumor tissue sampling for organoid development

    Procedure/Surgery

    Fresh tissue from colorectal tumors will be sampled and cultivated in 3D cultures for drug testing.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Primary resectable colon and rectal cancer1 intervention

Trial outcomes

Primary outcomes

1

Clinical logistics pipeline for patient-derived organoid development success rate

Estimate the feasibility of the implementation of functional diagnostics in a clinical setting. Outcome 1: Inclusion of 10 patients in a study pilot. Measurement 1: Patient inclusion rate per week. Measurement 2: Capacity for organoid development at laboratory facilities (number of patients possible to include per week). Outcome 2: Development of patient-derived organoids from patient tumor samples. Measurement 1: The success rate of organoid development (numbers of organoids developed from the total amount of patients included).

Time frame
March 2022 until March 2023
2

Sensitivity report for chemotherapy and cellular immunotherapy by clinical evaluation

Develop drug sensitivity report for clinical use, informing on the functional impact of anti-cancer therapies including cellular therapies ex vivo both by viability assays and real-time imaging analysis. The drug report will be developed to suit clinical use. The outcome will be measured in the clinical utility of the drug sensibility report for each patient and to what extent the report can be implemented in clinical practice for further drug selection studies. Measurement: Assessment of clinical utility by a panel of end-users, including oncologists, surgeons and patient representatives.

Time frame
March 2022 until March 2025
3

Induction of immunotherapy efficacy by chemotherapy in colorectal cancer, measured by advanced imaging analysis

Outcome: Identification of chemotherapy or chemotherapy combinations with or without targeted therapies that induce immunotherapy efficacy in colorectal cancer. Measurement: By exposing patient-derived organoids to chemotherapy and targeted agents in combination with chimeric antigen receptor (CAR) T cells, the investigators will use advanced imaging and imaging analysis to assess treatment efficacy of the individual therapies and combinations.

Time frame
May 2022 until March 2025

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Akershus University HospitalRecruiting1478, Lørenskog, AkershusNorwayNorway

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Akershus

Lead sponsor

Oncosyne AS

Collaborator

Oslo University Hospital

Collaborator