Clinical trial · Interventional
Study Comparing Radio Frequency Ablation Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM
A Prospective, Randomized, One-center Study Assessing Overall Survival Using RFA Plus Chemotherapy ± Target Therapy and Chemotherapy ± Target Therapy Alone in Patients With Unresectable Unresectable Colorectal Cancer Liver Metastases
- 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 date no prospective trials have been completed that demonstrated whether RFA is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in overall survival compared with chemotherapy (target therapy) alone. The primary objective of this trial is to determine overall survival for patients with colorectal cancer liver metastasis are treated with radiofrequency ablation plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy only.
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 Liver Metastasis | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy ± target therapy | Drug | — | UNRESOLVED |
| Radiofrequency Ablation (RFA) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- RFA plus chemotherapy ± target therapy
- interventionNames
- Device: Radiofrequency Ablation (RFA)
- Drug: chemotherapy ± target therapy
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- chemotherapy ± target therapy
- interventionNames
- Drug: chemotherapy ± target therapy
Primary outcomes (1)
- measure
- Overall survival in subjects receiving RFA plus chemotherapy ± target therapy compared to chemotherapy ± target therapy alone was assessed from the date of study entry until death from the disease.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: All patients must meet the following criteria: Patients must have incurable CRLM Patients must have no more than 10 liver metastases (LMs) remaining after surgical resection, with diameter less than 5cm Patients is medically eligible to receive RFA, as determined by the MDT (multidisciplinary team) Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 Age \> 18 years Subject life expectancy \> 3 months Platelets \> 100×103/mm3 Total bilirubin \<1.5mg/dl Creatinine level \< 2.0 mg/dl All patients must sign an informed consent form Exclusion Criteria: The CRLM is amenable to curative surgical therapy Uncorrectable coagulopathy Subject is pregnant, nursing, or wishes to become pregnant during the study Other serious medical condition (uncontrolled infection, uncontrolled cardiac disease) would preclude study treatment or impact survival Current or planned treatment with any experimental chemotherapy or target drugs
References
Publications (0)
Data not yet available