Clinical trial · Interventional
Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis
Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis (HELARC) ------ a Randomized Controlled Multicenter Clinical 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)
The surgical and local ablation strategy for the treatment of resectable synchronous and metachronous colorectal liver metastases(CRLM) has not still been defined. The purpose of this study is to compare two treatment strategies in which simultaneous resection of both primary and secondary tumor of synchronous CRLM(SCRLM) and resection of metachronous CRLM(MCRLM) is compared with resection of primary tumor and ablation of secondary tumor in SCRLM and ablation of MCRLM. Endpoints include the rate of severe complications and survival.
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 |
|---|---|---|---|
| Secondary Malignant Neoplasm of Liver | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CRLM ablation group | Device | — | UNRESOLVED |
| CRLM resection group | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CRLM resection group
- description
- Resection of both primary and secondary tumors in SCRLM and resection of MCRLM. Interventions: Simultaneous resection of both primary and secondary tumors in SCRLM and resection of MCRLM.
- interventionNames
- Procedure: CRLM resection group
- type
- EXPERIMENTAL
- label
- CRLM ablation group
- description
- Ablation of CRLM after resection of primary tumor in SCRLM and ablation of MCRLM. Interventions: Ablation of liver metastasis within 30 days after resection of primary tumor in SCRLM and ablation of MCRLM.
- interventionNames
- Device: CRLM ablation group
Primary outcomes (1)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. At least one metastatic adenocarcinoma of liver, histologically proven. 2. At least one adenocarcinoma of colon and/or rectum, histologically proven. 3. No local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion). 4. No extra-hepatic metastasis. 5. Extra-hepatic disease (EHD) suitable for hepatectomy, liver ablation and anesthesia as long as all sites of EHD disease are radically treated. 6. All the primary and secondary tumors which R0 resections are technically possible. (SCRLM: synchronous resection for both primary and secondary tumors, MCRLM: no local recurrence within 6 months after resection of primary tumor) 7. Residual hepatic volume\>30%-40%. 8. At least 2-3 hepatic segments remained after hepatectomy (except S1), residual liver with normal portal vein, hepatic artery and biliary duct, at least 1 of hepatic veins (left, middle and right) not invaded. 9. Tumor size ≤3 cm. 10. Tumor number≤ 3. 11. Tumors located ≥1.0 cm of vulnerable structures, e.g. colon, main trunk of portal vein, hepatic artery, hepatic vein and intrahepatic biliary duct. 12. suitable for both hepatectomy and local ablation after multiple disciplinary team(MDT) discussion. 13. Informed written consent. Exclusion Criteria: 1. Other malignant tumors history. 2. Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and abscesses, et al.). 3. Colorectal or hepatic tumor extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately. 4. Hepatic lesions diagnosed with ultrasound and MRI making complete ablation impossible immediately. 5. ≤ 2 hepatic segments remained after hepatectomy or residual hepatic volume﹤30%-40% 6. Non resectable lymph node metastasis. 7. American Society of Anesthesiologists(ASA) grading≥ IV and/or Eastern cooperative oncology group(ECOG) score≥ 2. (see appendix) 8. EHD is not recommended. 9. Physical or psychological dependence. 10. Pregnant or breast feeding women. 11. Not controlled preoperational infection. 12. Enrolled in other clinical trials within 4 weeks. Other clinical or laboratorial condition not recommended by investigators.
References
Publications (5)
- BACKGROUNDBrody H. Colorectal cancer. Nature. 2015 May 14;521(7551):S1. doi: 10.1038/521S1a. No abstract available. PMID 25970450
- BACKGROUNDJoranger P, Nesbakken A, Hoff G, Sorbye H, Oshaug A, Aas E. Modeling and validating the cost and clinical pathway of colorectal cancer. Med Decis Making. 2015 Feb;35(2):255-65. doi: 10.1177/0272989X14544749. Epub 2014 Jul 29. PMID 25073464
- BACKGROUNDKopetz S, Chang GJ, Overman MJ, Eng C, Sargent DJ, Larson DW, Grothey A, Vauthey JN, Nagorney DM, McWilliams RR. Improved survival in metastatic colorectal cancer is associated with adoption of hepatic resection and improved chemotherapy. J Clin Oncol. 2009 Aug 1;27(22):3677-83. doi: 10.1200/JCO.2008.20.5278. Epub 2009 May 26. PMID 19470929
- BACKGROUNDBethke A, Kuhne K, Platzek I, Stroszczynski C. Neoadjuvant treatment of colorectal liver metastases is associated with altered contrast enhancement on computed tomography. Cancer Imaging. 2011 Jun 29;11(1):91-9. doi: 10.1102/1470-7330.2011.0015. PMID 21771709
- BACKGROUNDLivraghi T. Single HCC smaller than 2 cm: surgery or ablation: interventional oncologist's perspective. J Hepatobiliary Pancreat Sci. 2010 Jul;17(4):425-9. doi: 10.1007/s00534-009-0244-x. Epub 2009 Nov 5. PMID 19890600