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Tailoring Treatment in Colorectal Cancer (TargetCRC)

U

University Hospital, Akershus

Status

Enrolling

Conditions

Colorectal Neoplasms

Treatments

Procedure: Tumor tissue sampling for organoid development

Study type

Observational

Funder types

Other

Identifiers

NCT05401318
350208 (REK)

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

40 participants in 1 patient group

Primary resectable colon and rectal cancer
Description:
Patients with primary resectable, localized colon and rectal cancer eligible for blood and tissue sampling for organoid development.
Treatment:
Procedure: Tumor tissue sampling for organoid development

Trial contacts and locations

1

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Central trial contact

Sebastian Meltzer, M.D. Ph.D.

Data sourced from clinicaltrials.gov

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