Trials / Recruiting
RecruitingNCT05401318
Tailoring Treatment in Colorectal Cancer
Pilot Study for Ex Vivo Tailoring of Treatment in Colorectal Cancer
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (estimated)
- Sponsor
- University Hospital, Akershus · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Tumor tissue sampling for organoid development | Fresh tissue from colorectal tumors will be sampled and cultivated in 3D cultures for drug testing. |
Timeline
- Start date
- 2022-03-28
- Primary completion
- 2025-03-28
- Completion
- 2027-01-01
- First posted
- 2022-06-02
- Last updated
- 2024-08-06
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT05401318. Inclusion in this directory is not an endorsement.