Clinical trial · Interventional
The Role and Safety of Radiofrequency Ablation in Recurrent Liver Metastasis of Colorectal Cancer
The Role and Safety of Radiofrequency Ablation in the Multidisciplinary Treatment of Intrahepatic Recurrence After Colorectal Cancer Liver Metastasis Surgery
- 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)
The goal of this clinical trial is to learn if radiofrequency ablation works to treat recurrent colorectal cancer liver metastases after surgery in adults. It will also learn about the safety of radiofrequency ablation. The main questions it aims to answer are: Is radiofrequency ablation safe and effective in the treatment of recurrent colorectal cancer liver metastases? What medical problems do participants have when treating with radiofrequency ablation? Does radiofrequency ablation enable patients with recurrent colorectal cancer liver metastases to live longer? Researchers will compare systemic therapy combined with radiofrequency ablation to systemic therapy to see if radiofrequency ablation works to treat liver metastases better. Participants will: Receive systemic treatment for colorectal cancer liver metastases. Undergo (or not) radiofrequency ablation for colorectal cancer liver metastases. Visit the hospital once every 3 months for checkups and tests.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colo-rectal Cancer | — | UNRESOLVED | — |
| Liver Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- systemic therapy
- description
- This arm includes patients with intrahepatic recurrence of colorectal cancer liver metastases who underwent systemic therapy.
- type
- EXPERIMENTAL
- label
- systemic therapy combined with radiofrequency ablation
- description
- This arm includes patients with intrahepatic recurrence of colorectal cancer liver metastases who underwent systemic therapy combined with radiofrequency ablation.
- interventionNames
- Procedure: Radiofrequency ablation
Primary outcomes (1)
- measure
- liver progression-free survival
- timeFrame
- 2 years
- description
- Time from initial treatment to intrahepatic disease progression or patient death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with colorectal cancer whose primary lesions have been resected or can be controlled; 2. Multiple confined lesions in the liver, the number of which can be defined; 3. The liver contains at least 2 lesions suitable for radiofrequency ablation; 4. The maximum diameter of the intrahepatic tumor is \<5 cm; 5. The location of the hepatic lesion does not show obvious invasion with neighboring organs or large blood vessels; 6. No extrahepatic metastases or stable extrahepatic metastases; 7. Re-operative hepatic surgical resection is not indicated or refused; 8. Ultrasound or ultrasonography can show intrahepatic lesions; 9. The patient and his/her family request active treatment; 10. Voluntary informed consent; 11. Male or female at least 18 years of age; 12. Platelet count \>50, 000/mm3 and prothrombin activity \>50%; 13. Subjects are willing to return to the study center for study follow-up; 14. Life expectancy ≥ 6 months. Exclusion Criteria: 1. Suffering from, but not limited to, the following serious illnesses: congestive heart failure, myocardial infarction or cerebrovascular accident, or life-threatening cardiac arrhythmia within the last 6 months; 2. Pregnancy or lactation. Women of childbearing potential must have a negative serum pregnancy test prior to receiving study treatment; 3. Known hypersensitivity to any of the intravenous imaging agents that will be used in the study; 4. Have portal or hepatic vein tumor infiltration/cancer embolism; 5. Prothrombinogen international normalized ratio \>1.5 times the upper limit of normal (UNL) at the study center; 6. Platelet count \<50, 000/mm3, absolute neutrophil count \<1500/mm3, or hemoglobin value \<10.0 g/dL; 7. Serum creatinine ≥ 2.5 mg/dL or calculated creatinine clearance (CrCl) ≤ 25.0 ml/min; 8. Serum bilirubin \>3.0 mg/dL; 9. Serum albumin \<2.8 g/dL; 10. Body temperature \>101°F (38.3°C) immediately prior to study treatment; 11. Being treated with other investigational drugs; 12. Heart failure NYHA functional class III or IV. 13. Any other circumstances that the investigator deems inappropriate for enrollment.
References
Publications (0)
Data not yet available