Clinical trial · Observational
Cetuximab Sensitivity Correlation Between Patient-Derived Organoids and Clinical Response in Colon Cancer Patients.
Patient-derived Organoids of RAS/RAF Wild-type Metastatic Right Colon Cancer to Test the Sensitivity and Clinical Consistency of Combined Treatment of Cetuximab.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Eighty patients with RAS/RAF wild-type metastatic right colon cancer will be enrolled and undergo a fresh biopsy of tumor lesion before the standard treatment of chemotherapy. The investigators will establish organoids from the pre-treatment biopsies. Organoids will be exposed to the chemotherapy drugs or chemotherapy drugs combined with cetuximab used for each patient. The sensitivity of chemotherapy drugs or combined cetuximab will be tested in the organoids model. Chemotherapy strategies including 5-fluorouracil only, irinotecan only, oxaliplatin only, FOLFOX, and FOLFIRI. The purpose of this study is to evaluate the consistency and accuracy of a Patient-Derived Organoid (PDO) model of colon cancer to predict the clinical efficacy of combined treatment of cetuximab, which to formulate the best therapy regimen for each given patient.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Organoids | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cancer patient
- description
- RAS/RAF wild-type metastatic right colon cancer patients receiving chemotherapy or chemotherapy combined target therapy treatment.
- interventionNames
- Procedure: Tumor biopsy
Primary outcomes (1)
- measure
- Correlation of ex vivo sensitivity test on patient-derived organoid models with clinical outcomes
- timeFrame
- 2021.05-2023.05
- description
- The drug sensitivity tests on patient-derived tumor organoids will compare with the clinical response of the chemo- or targeted therapy treatment. The correlation of organoids sensitivity and patient response will be evaluated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age from 18 to 70 years old, no gender limit 2. The primary tumor is located in the right colon, including the ileocecal area, ascending colon, liver flexure, and the right part of the transverse colon. 3. Pathologically proved primary intestinal tumor with simultaneous / metachronous metastasis 4. Molecular pathology confirmed as RAS/RAF wild type 5. Can tolerate and cooperate with the completion of chemotherapy and targeted therapy 6. Tissues can be obtained through puncture or colonoscopy for organoid culture 7. Complete clinical data, as well as efficacy evaluation data, can be obtained Exclusion Criteria: 1. Less than 18 years of age or more than 70 years of age 2. The primary tumor is located in the left colon or rectum 3. Pathology results can't confirm as colon cancer 4. RAS and RAF are mutant confirmed by molecular pathology 5. Refuse to cooperate and complete the treatment, or there is a contraindication for chemotherapy or targeted therapy 6. No available metastatic lesions tissue 7. Unable to obtain complete clinical data or efficacy evaluation data
References
Publications (0)
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