Clinical trial NCT05401318: Tailoring Treatment in Colorectal Cancer
Official title: Pilot Study for Ex Vivo Tailoring of Treatment in Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Neoplasms
Keywords: Leucovorin
Oxaliplatin
Fluorouracil
Immunotherapy
Colorectal cancer
CAR T-cells
Patient-Derived Organoids
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Oncosyne AS
name: Oslo University Hospital
First posted: 2022-06-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Detailed description: Primary hypothesis: Drug screening of patient-derived organoids is a feasible method to identify effective and ineffective therapies for personalized colorectal cancer treatment.

Secondary hypothesis: Pre-treatment with cytotoxic agents can induce cellular immunotherapy efficacy against solid tumors in a colorectal cancer patient-derived organoid model.

Primary objective: To provide methodology and competencies for a clinical trial on drug screening on patient-derived organoids as an approach in personalized cancer treatment.

Secondary objective: To explore induction of cellular immunotherapy efficacy in colorectal cancer patient-derived organoids by chemotherapy or targeted agents.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- Unable/unwilling to sign the informed consent form.

Primary outcomes:
measure: Clinical logistics pipeline for patient-derived organoid development success rate
timeFrame: March 2022 until March 2023
measure: Sensitivity report for chemotherapy and cellular immunotherapy by clinical evaluation
timeFrame: March 2022 until March 2025
measure: Induction of immunotherapy efficacy by chemotherapy in colorectal cancer, measured by advanced imaging analysis
timeFrame: May 2022 until March 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
state: Viken
Study officials:
affiliation: University Hospital, Akershus
name: Sebastian Meltzer, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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