Clinical trial · Interventional
Treatment Response Evaluation in Patients With Non-resectable Colorectal Liver Metastases A Feasibility Study
- 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)
More than 4200 new cases of colorectal cancer (CRC) are diagnosed each year in Denmark, and 30.000 patients live with the diagnosis. Up to 40% of CRC patients will have synchronous liver metastases (LM) at the time of the diagnosis or will develop metachronous LM during the course of their disease. CRC-LM are treated with a combination of chemotherapy and liver surgery, but less than 25% of the referred patients with CRC-LM may be treated with curative intend. If looking at population-based data this figure drops to less than 5%. During pre-operative chemotherapy the treatment response is monitored by CT and MR scans, and the patients are then discussed on multidisciplinary team (MDT) conferences. However, monitoring is inaccurate since the simple measurement of size of the liver lesions cannot provide reliable evidence of the treatment response. The cancer cells may actually have been replaced by scar tissue but without any shrinkage. The question is how may we improve the evaluation of treatment response? With the goal of improving the assessment of the response to chemotherapy, and thereby only treat the patients that will benefit from chemotherapy?
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 |
|---|---|---|---|
| Liver Metastasis Colon Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| liver biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Biopsi arm
- interventionNames
- Procedure: liver biopsy
Primary outcomes (1)
- measure
- Tissue biopsy
- timeFrame
- through study completion, an average of 2 months
- description
- Is it possible to obtain a representative laparoscopic (LAP) specimen/biopsy of the marked tissue after chemotherapy?
Secondary outcomes (2)
- measure
- Fiducial marker
- timeFrame
- through study completion, an average of 2 months
- description
- Is it safe to perform LUS guided marking of CRC-LM?
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with non-resectable liver metastasis based on a MDT evaluation and the consensus guidelines regarding oncological and technical resectability criteria 2. Expected survival \> 6 months (with chemotherapy) 3. Informed consent Exclusion Criteria: * 1\. Unfit for chemotherapy and/or laparoscopic evaluation 2. History of other malignant diseases 3. Contraindications to general anesthesia or laparoscopic access (e.g. history of massive abdominal adhesions).
References
Publications (0)
Data not yet available