Clinical trial · Observational
Study to Identify Mechanisms of Resistance to Standard Therapy in Patients With Metastatic Colorectal Cancer
Prospective Study to Identify Molecular Mechanisms of Clinical Resistance to Standard First-line Therapy in Patients With Metastatic Colorectal Cancer
- 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)
This is a multicenter translational study to understand therapeutic resistance in patients undergoing first-line chemotherapy (FOLFOX/Avastin, or FOLFIRI/Avastin) for metastatic colorectal cancer. Tissue samples from liver metastasis will be collected and banked before the start of chemotherapy and at the time of progression. Additionally, blood samples will be drawn monthly and stored in the tissue biobank.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Needle core biopsies of liver metastasis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- FOLFOX, XELOX or FOLFIRI +/- bevacizumab
- description
- Patients are scheduled to receive first-line treatment for metastatic disease. They should be receiving at least one component of either FOLFOX, XELOX or FOLFIRI regimen with or without bevacizumab.
- interventionNames
- Other: Needle core biopsies of liver metastasis
Primary outcomes (1)
- measure
- Changes in biomarkers in patients that have acquired clinical resistance.
- timeFrame
- 4 years
- description
- Liver needle core biopsies are obtained pre-treatment and at progression of disease from all patients. These are used to discover exploratory biomarkers of resistance to FOLFOX/bevacizumab and FOLFIRI/bevacizumab
Secondary outcomes (1)
- measure
- Number of participants with adverse events relating to the liver biopsy procedure
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with a histologically confirmed diagnosis of colorectal cancer, with at least one liver metastasis site available for biopsy. 2. For patients with liver only disease, patients deemed not to be initially resectable 3. Scheduled to receive first-line chemotherapy (FOLFOX/bevacizumab or FOLFIRI/bevacizumab) for metastatic disease. 4. Measurable metastatic disease (at least one unidimensionally measurable lesion) present after planned biopsy of metastatic site(s). 5. ECOG 0, 1 or 2. 6. Life expectancy of 12 or more weeks. 7. Age \> 18 years. 8. Able to adhere to the study visit schedule and other protocol requirements. 9. Normal coagulation profile (PT, PTT, INR). Exclusion Criteria: 1. Patients with initially resectable liver only metastases 2. Have received prior therapy for metastatic cancer. Prior adjuvant therapy is allowed. 3. Inadequate or unusable tissue as the only tissue available for biopsy. 4. Contraindication to any of the components of the the first-line chemotherapy regimen. 5. Known brain metastases or meningeal disease. 6. Female patients who are pregnant or breastfeeding. 7. Concurrent treatment with other anti-cancer therapy (palliative radiation is allowed but patients must have a metastatic site available for re-biopsy that has not been irradiated). 8. Abnormal coagulation profile, any anti-coagulant therapy. 9. Known infection with HIV.
References
Publications (0)
Data not yet available