Clinical trial · Observational
To Identify KRAS Gene and Safe Margin in Association With Outcome in Colorectal Liver Metastases Following Ultrasound-guided Radiofrequency Ablation
A Prospective Study to Identify KRAS Gene and Safe Margin in Association With Outcome in Colorectal Liver Metastases Following Ultrasound-guided Radiofrequency Ablation
NCT04417010CI-TRIAL-00045454unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
To investigate the clinical effect of radiofrequency ablation on colorectal cancer liver metastases with different KRAS gene status
Conditions
Conditions (5)
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 |
| KRAS Gene | — | UNRESOLVED | — |
| Liver Metastasis | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Radiofrequency Ablation | — | UNRESOLVED | — |
| Safe Margin | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- local tumor progression
- timeFrame
- 2020-06-01-2023-05-31
- description
- the appearance of tumor foci at the edge of the ablation zones after at least one contrast-enhanced follow-up study has documented adequate ablation and covered by the ablation zone in the target tumor and surrounding ablation margin using imaging criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed as liver metastasis of colorectal cancer; 2. There are no more than 3 liver metastases and all the lesions are not more than 5 cm; or no more than 6 liver metastases and all the lesions are not more than 3.0 cm; 3. The primary lesion of colorectal cancer has been treated curatively or is planned to undergo curative treatment; 4. KRAS gene test results can be obtained for primary or metastatic foci; 5. Signing informed consent voluntarily; 6. Men or women who have reached the age of 18; 7. Ultrasound or ultrasound contrast can clearly show the lesion and guide RFA treatment; 8. Platelet count\> 50,000/mm3, prothrombin activity\> 50%; 9. Child-Pugh grade A or B of liver disease, but no hepatic encephalopathy or/and ascites; 10. Subjects are willing to return to the research center for research follow-up; 11. Life expectancy ≥ 6 months- Exclusion Criteria: 1. suffer from but not limited to the following serious diseases: congestive heart failure, myocardial infarction or cerebrovascular accident, or life-threatening arrhythmia in the past 6 months; 2. During pregnancy or lactation. Before receiving research treatment, women of childbearing age must have a negative serum pregnancy test; 3. Any known allergic reactions to the intravenous imaging agent used in this study; 4. There is portal vein or hepatic vein tumor infiltration/carcinoma; 5. International normalized ratio of prothrombin\> 1.5 times the upper limit of normal value (UNL) of the research center; 6. Platelet count \<50,000/mm3, absolute neutrophil count \<1500/mm3, or heme value \<10.0g/dL; 7. Serum creatinine ≥2.5mg/dL or calculated creatinine clearance (CrCl) ≤25.0ml/min; 8. Serum bilirubin\>3.0mg/dL; 9. Serum albumin \<2.8g/dL; 10. Body temperature \>101°F (38.3°C) immediately before study treatment; 11. being treated with other research drugs; 12. Heart failure NYHA function grade is III or IV .
References
Publications (0)
Data not yet available
No reference posted for this study.