Secondary Malignant Neoplasm of LiverHELARCNCT02886104
Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis
A study testing CRLM resection group and CRLM ablation group in people with Secondary Malignant Neoplasm of Liver, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Secondary Malignant Neoplasm of Liver
- What is being tested?
- CRLM resection group and CRLM ablation group
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 548 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one metastatic adenocarcinoma of liver, histologically proven.
- At least one adenocarcinoma of colon and/or rectum, histologically proven.
- No local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion).
- No extra-hepatic metastasis.
- Extra-hepatic disease (EHD) suitable for hepatectomy, liver ablation and anesthesia as long as all sites of EHD disease are radically treated.
- 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)
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- Residual hepatic volume>30%-40%.
- 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.
- Tumor size ≤3 cm.
- Tumor number≤ 3.
- Tumors located ≥1.0 cm of vulnerable structures, e.g. colon, main trunk of portal vein, hepatic artery, hepatic vein and intrahepatic biliary duct.
- suitable for both hepatectomy and local ablation after multiple disciplinary team(MDT) discussion.
- Informed written consent.
Who cannot join
- Other malignant tumors history.
- Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and abscesses, et al.).
- Colorectal or hepatic tumor extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately.
- Hepatic lesions diagnosed with ultrasound and MRI making complete ablation impossible immediately.
- ≤ 2 hepatic segments remained after hepatectomy or residual hepatic volume﹤30%-40%
- Non resectable lymph node metastasis.
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- American Society of Anesthesiologists(ASA) grading≥ IV and/or Eastern cooperative oncology group(ECOG) score≥ 2. (see appendix)
- EHD is not recommended.
- Physical or psychological dependence.
- Pregnant or breast feeding women.
- Not controlled preoperational infection.
- Enrolled in other clinical trials within 4 weeks. Other clinical or laboratorial condition not recommended by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 6th Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510655
Meijin Huang, MD,PHD, +8613924073322, maymay0129@139.com
Jun Huang, MD,PHD, +8613926451242, huangj97@mail.sysu.edu.cn
About this study
Official title: Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis (HELARC) ------ a Randomized Controlled Multicenter Clinical Study
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.
Read the detailed description
Colorectal cancer(CRC) kills more than 700,000 patients every year, which is nowadays the world's 3rd common and the 4th deadly tumor. About 50% CRC patients will finally develop colorectal liver metastasis (CRLM). Among the CRLM patients, 20-25% of CRC are found with synchronous colorectal liver metastases (SCRLM) at the first visit. Meanwhile, about 20-30% CRC patients suffer by metachronous colorectal liver metastasis (MCRLM) even after radical resection of primary tumor. It is nowadays admitted that the R0 resection of both primary and secondary tumors in SCRLM and R0 resection of MCRLM represents a feasible and potential curative treatment in patients with resectable CRLM(RCRLM). However, the treatment strategy for some RCRLM (tumor number≤3 and tumor size≤3.0cm), such as whether to choose hepatectomy or local ablation, still remains in debate. In primary hepatocellular carcinoma(HCC), local ablation has been proved to has similar curative effect to that of hepatectomy. Compared to hepatectomy, local ablation has less trauma and more rapid recovery and possible lower hospitalization cost. The curative effect of local ablation is mainly influenced by tumor site and tumor size. On the other side, some RCRLM might develop repeat recurrences even after "R0" resection due to the imaging undetectable micro metastasis. Thus, local ablation might be more suitable for some repeat recurrent CRLM. The aim of this study is to compare the efficacy/safety of local ablation with hepatectomy for RCRLM (tumor number≤3, tumor size≤3.0cm), including both SCRLM and MCRLM. Patients are randomized to CRLM resection group and local ablation group. The primary endpoint is overall survival. Secondary endpoints evaluate the rate of patients with at least one severe complication within 30 days after surgery/ablation and long-term clinical outcomes, in particular disease-free survival.
- Conditions
- Secondary Malignant Neoplasm of Liver
- Being tested
- CRLM resection group, CRLM ablation group
- Keywords
- synchronous, metachronous, colorectal liver metastasis, resection, ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRLM resection groupProcedure or surgery
Also called Hepatectomy
Simultaneous resection of both primary and secondary tumors in synchronous CRLM or resection of metachronous CRLM.
CRLM ablation groupDevice
Also called Microwave ablation
Microwave ablation of CRLM with a 2.15-gigahertz(GHz) microwave generator and a 14 gauge diameter transcutaneous antenna within 30 days after resection of primary tumor in synchronous CRLM or ablation of metachronous CRLM.
| Study group | Role | What they receive |
|---|---|---|
| CRLM resection group | Active comparator | 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. Receives: Procedure: CRLM resection group |
| CRLM ablation group | Experimental | 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. Receives: Device: CRLM ablation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 3 years
Secondary outcomes (5)
R0 resection rate in both primary and secondary tumor in CRLM
Measured: Day of surgery
Death rate during hospitalization or within 30 days after surgery/ablation
Measured: 30 days after surgery/ablation
Rate of patients with at least one postoperative severe complication within 30 days after surgery/ablation
Measured: 30 days after surgery/ablation
Disease-free survival and 1, 2 and 3-years disease-free survival rate
Measured: 1, 2 and 3-years
Complete ablation rate in CRLM
Measured: Day of ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2021 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Secondary Malignant Neoplasm of LiverStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 548 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor
- Investigators
- Meijin Huang, MD,PHD, Principal investigator, The 6th Affiliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886104
- Sponsor's protocol ID
- E2016026
- Acronym
- HELARC
- Status last verified
- Aug 2016
- First submitted
- 24 Aug 2016
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Brody H. Colorectal cancer. Nature. 2015 May 14;521(7551):S1. doi: 10.1038/521S1a. No abstract available.
PubMed 25970450Joranger 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.
PubMed 25073464Kopetz 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.
PubMed 19470929Bethke 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.
PubMed 21771709Livraghi 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.
PubMed 19890600
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis (HELARC) ------ a Randomized Controlled Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT02886104
- Acronym / sponsor ID
- HELARC / E2016026
- Conditions
- Secondary Malignant Neoplasm of Liver
- Keywords
- synchronous, metachronous, colorectal liver metastasis, resection, ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 548 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital, Sun Yat-Sen University
- Study start
- Aug 2016
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Colorectal cancer(CRC) kills more than 700,000 patients every year, which is nowadays the world's 3rd common and the 4th deadly tumor. About 50% CRC patients will finally develop colorectal liver metastasis (CRLM). Among the CRLM patients, 20-25% of CRC are found with synchronous colorectal liver metastases (SCRLM) at the first visit. Meanwhile, about 20-30% CRC patients suffer by metachronous colorectal liver metastasis (MCRLM) even after radical resection of primary tumor. It is nowadays admitted that the R0 resection of both primary and secondary tumors in SCRLM and R0 resection of MCRLM represents a feasible and potential curative treatment in patients with resectable CRLM(RCRLM). However, the treatment strategy for some RCRLM (tumor number≤3 and tumor size≤3.0cm), such as whether to choose hepatectomy or local ablation, still remains in debate. In primary hepatocellular carcinoma(HCC), local ablation has been proved to has similar curative effect to that of hepatectomy. Compared to hepatectomy, local ablation has less trauma and more rapid recovery and possible lower hospitalization cost. The curative effect of local ablation is mainly influenced by tumor site and tumor size. On the other side, some RCRLM might develop repeat recurrences even after "R0" resection due to the imaging undetectable micro metastasis. Thus, local ablation might be more suitable for some repeat recurrent CRLM. The aim of this study is to compare the efficacy/safety of local ablation with hepatectomy for RCRLM (tumor number≤3, tumor size≤3.0cm), including both SCRLM and MCRLM. Patients are randomized to CRLM resection group and local ablation group. The primary endpoint is overall survival. Secondary endpoints evaluate the rate of patients with at least one severe complication within 30 days after surgery/ablation and long-term clinical outcomes, in particular disease-free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRLM resection group | Active comparator | Procedure: CRLM resection groupResection 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. |
| CRLM ablation group | Experimental | Device: CRLM ablation groupAblation 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- At least one metastatic adenocarcinoma of liver, histologically proven.
- At least one adenocarcinoma of colon and/or rectum, histologically proven.
- No local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion).
- No extra-hepatic metastasis.
- Extra-hepatic disease (EHD) suitable for hepatectomy, liver ablation and anesthesia as long as all sites of EHD disease are radically treated.
Key exclusion criteria (12 listed)
- Other malignant tumors history.
- Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and abscesses, et al.).
- Colorectal or hepatic tumor extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately.
- Hepatic lesions diagnosed with ultrasound and MRI making complete ablation impossible immediately.
- ≤ 2 hepatic segments remained after hepatectomy or residual hepatic volume﹤30%-40%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRLM resection groupAlso: HepatectomySimultaneous resection of both primary and secondary tumors in synchronous CRLM or resection of metachronous CRLM. | Procedure or surgery | CRLM resection group |
| CRLM ablation groupAlso: Microwave ablationMicrowave ablation of CRLM with a 2.15-gigahertz(GHz) microwave generator and a 14 gauge diameter transcutaneous antenna within 30 days after resection of primary tumor in synchronous CRLM or ablation of metachronous CRLM. | Device | CRLM ablation group |
Primary outcome
Overall survival
Time frame: 3 years
5 secondary outcomes
R0 resection rate in both primary and secondary tumor in CRLM
Time frame: Day of surgery
Death rate during hospitalization or within 30 days after surgery/ablation
Time frame: 30 days after surgery/ablation
Rate of patients with at least one postoperative severe complication within 30 days after surgery/ablation
Time frame: 30 days after surgery/ablation
Disease-free survival and 1, 2 and 3-years disease-free survival rate
Time frame: 1, 2 and 3-years
Complete ablation rate in CRLM
Time frame: Day of ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
- Background: PubMed 25970450Brody H. Colorectal cancer. Nature. 2015 May 14;521(7551):S1. doi: 10.1038/521S1a. No abstract available.
- Background: PubMed 25073464Joranger 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.
- Background: PubMed 19470929Kopetz 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.
- Background: PubMed 21771709Bethke 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.
- Background: PubMed 19890600Livraghi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meijin Huang, MD,PHD principal investigator
The 6th Affiliated Hospital of Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRLM resection group and CRLM ablation group in people with Secondary Malignant Neoplasm of Liver, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meijin Huang, MD,PHD (+8613924073322, maymay0129@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02886104, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2016.