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NCT Number: NCT05401318

Tailoring Treatment in Colorectal Cancer

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akershus University Hospital

Lørenskog, Akershus, 1478, Norway

Location status: Recruiting

Location contact

Sebastian Meltzer

CONTACT

[email protected]

93608514

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tumor tissue sampling for organoid development

Procedure

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

Primary outcomes

  1. Clinical logistics pipeline for patient-derived organoid development success rate

    Time frame: March 2022 until March 2023

    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).

  2. Sensitivity report for chemotherapy and cellular immunotherapy by clinical evaluation

    Time frame: March 2022 until March 2025

    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.

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

    Time frame: May 2022 until March 2025

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sebastian Meltzer, M.D. Ph.D.

CONTACT

[email protected]

+4767960000

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • Oncosyne AS
  • Oslo University Hospital

Registry information

Official study title

Pilot Study for Ex Vivo Tailoring of Treatment in Colorectal Cancer

Acronym: TargetCRC

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Jun 2, 2022
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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