Colorectal Liver Metastasis (CRLM)ASRS-CRLMNCT07559851
Ablation With Systemic Therapy vs Liver Resection With Systemic Therapy for Colorectal Liver Metastasis
An observational study of Colorectal Liver Metastasis (CRLM), run by The First Hospital of Jilin University at 1 site in China.
Trial summary
For patients with colorectal liver metastases (CRLM) ≤5 cm, Clinical guidelines recommend surgery, but a growing number of studies have shown that thermal ablation is as effective as surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Liver Metastasis (CRLM)
- What is being tested?
- ablation combined with systemic therapy and liver resection combined with systemic therapy
- Type of treatment
- Surgery or procedure
- How many people
- 151 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Mar 2025
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective study included patients with colorectal liver metastases (≤5 lesions, ≤5 cm) who underwent thermal ablation with systemic therapy or liver resection with systemic therapy at four hospitals between January 2018 and April 2023.
Who may be able to join
- Age between 18 and 85 years.
- Primary tumor resected with R0 resection and pathological confirmation of colorectal adenocarcinoma.
- Liver metastasis confirmed by any two of the following examinations: contrast-enhanced CT, enhanced MRI, CEUS, PET-CT, or pathology.
- Liver metastases with maximum diameter ≤ 5 cm and ≤ 5 lesions.
Who cannot join
- History of other local treatments for liver metastasis prior to ultrasound-guided microwave ablation/liver resection.
- With concurrent extrahepatic metastases.
- With concurrent other malignancies.
- With incomplete clinical data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Ablation With Systemic Therapy vs Liver Resection With Systemic Therapy in Colorectal Liver Metastasis: A Multi-center Retrospective Cohort Study
For patients with colorectal liver metastases (CRLM) ≤5 cm, Clinical guidelines recommend surgery, but a growing number of studies have shown that thermal ablation is as effective as surgery. However, the optimal treatment strategy remains unclear.This study aimed to compare outcomes between patients who underwent ablation with systemic therapy or liver resection with systemic therapy for CRLM less than 5 cm in diameter.
Read the detailed description
Currently, the multidisciplinary team (MDT) model is recommended for the treatment of colorectal liver metastases in clinical practice, with personalized treatment goals and comprehensive treatment to achieve a tumor-free state. For liver metastases that are initially curable, surgical treatment should be performed in a timely manner. Although there are some controversies, surgical resection combined with systemic therapy is still considered the standard treatment . Liver resection alone may not be able to achieve complete cure, while preoperative systemic therapy can help eradicate micro-metastases, and postoperative systemic therapy can reduce the recurrence rate.For liver metastases that are initially unresectable, some lesions can be converted to resectable lesions through systemic therapy with or without targeted therapy. Recently, a phase Ⅲ randomized controlled clinical trial showed that thermal ablation and surgical resection achieve similar overall survival and progression-free survival for patients with resectable CRLM of 3 cm or less in diameter. However, for CRLM of 5 cm or less in diameter, the optimal treatment strategy remains unclear.
Therefore, this study aimed to compare the progression-free survival (PFS), overall survival (OS), and local recurrence rate (LRR) between patients with CRLM less than 5 cm in diameter who underwent ultrasound-guided ablation with systemic therapy and liver resection with systemic therapy.
- Conditions
- Colorectal Liver Metastasis (CRLM)
- Being tested
- ablation combined with systemic therapy, liver resection combined with systemic therapy
- Keywords
- Colorectal liver metastases, microwave ablation, progression-free survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ablation combined with systemic therapyProcedure or surgery
ltrasound-guided Microwave Ablation was performed using a GE LOGIQ E9 system with a C1-6 transducer, Nanjing Yigao ECO-100A1/ECO-100AL9 microwave device, and ECO-200F/100A6 disposable needles. Sonovue was used for CEUS. Single-needle multi-point ablation was performed for lesions <3 cm, and double-needle ablation for lesions ≥3 cm, with needles ≤2 cm apart. Ablation power was 50-60 W, with a 3-6 min duration per point.Real-time ultrasound guided needle placement to avoid surrounding structures. After ablation, the needle was withdrawn, and the track sealed.Post-procedure, grayscale or CEUS confirmed the ablation coverage with a 5-10 mm safety margin. A follow-up CEUS was performed 1 day later to assess treatment efficacy.
Systemic therapy was given for approximately 6 cycles. Patients received systemic therapy 2-4 weeks before or after ablation. Systemic therapy regimens included FOLFOX, XELOX, FOLFIRI, and FOLFOXIRI, with or without bevacizumab or cetuximab.
liver resection combined with systemic therapyProcedure or surgery
Laparoscopic Partial Liver Resection：Patients underwent laparoscopic partial liver resection, including exploration for extrahepatic metastases, resection of the liver lesion with surrounding tissue, and placement of a drainage tube. The procedure is performed under CO2 pneumoperitoneum with minimal invasive access via multiple ports.
Systemic therapy was given for approximately 6 cycles. Patients received systemic therapy 2-4 weeks before or after liver resection. Systemic therapy regimens included FOLFOX, XELOX, FOLFIRI, and FOLFOXIRI, with or without bevacizumab or cetuximab.
| Study group | Role | What they receive |
|---|---|---|
| AS | Patients who underwent ablation combined with systemic therapy for colorectal liver metastasis (CRLM) were included in the AS group. Receives: Procedure: ablation combined with systemic therapy | |
| RS | Patients who underwent liver resection combined with systemic therapy for colorectal liver metastasis (CRLM) were included in the RS group. Receives: Procedure: liver resection combined with systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Disease progression is defined as the appearance of metastatic tumors outside the liver or local recurrence or new tumors within the liver.The definition of Progression-Free Survival (PFS) is the time from the start of treatment to disease progression or death.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Jan 2018
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Liver Metastasis (CRLM)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559851
- Sponsor's protocol ID
- 2024-HS-142
- Acronym
- ASRS-CRLM
- Status last verified
- Aug 2025
- First submitted
- 24 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Ablation With Systemic Therapy vs Liver Resection With Systemic Therapy in Colorectal Liver Metastasis: A Multi-center Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07559851
- Acronym / sponsor ID
- ASRS-CRLM / 2024-HS-142
- Conditions
- Colorectal Liver Metastasis (CRLM)
- Keywords
- Colorectal liver metastases, microwave ablation, progression-free survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 30 Apr 2026 (actual)
- 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.
For patients with colorectal liver metastases (CRLM) ≤5 cm, Clinical guidelines recommend surgery, but a growing number of studies have shown that thermal ablation is as effective as surgery. However, the optimal treatment strategy remains unclear.This study aimed to compare outcomes between patients who underwent ablation with systemic therapy or liver resection with systemic therapy for CRLM less than 5 cm in diameter.
Detailed description
Currently, the multidisciplinary team (MDT) model is recommended for the treatment of colorectal liver metastases in clinical practice, with personalized treatment goals and comprehensive treatment to achieve a tumor-free state. For liver metastases that are initially curable, surgical treatment should be performed in a timely manner. Although there are some controversies, surgical resection combined with systemic therapy is still considered the standard treatment . Liver resection alone may not be able to achieve complete cure, while preoperative systemic therapy can help eradicate micro-metastases, and postoperative systemic therapy can reduce the recurrence rate.For liver metastases that are initially unresectable, some lesions can be converted to resectable lesions through systemic therapy with or without targeted therapy. Recently, a phase Ⅲ randomized controlled clinical trial showed that thermal ablation and surgical resection achieve similar overall survival and progression-free survival for patients with resectable CRLM of 3 cm or less in diameter. However, for CRLM of 5 cm or less in diameter, the optimal treatment strategy remains unclear.
Therefore, this study aimed to compare the progression-free survival (PFS), overall survival (OS), and local recurrence rate (LRR) between patients with CRLM less than 5 cm in diameter who underwent ultrasound-guided ablation with systemic therapy and liver resection with systemic therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AS | – | Procedure: ablation combined with systemic therapyPatients who underwent ablation combined with systemic therapy for colorectal liver metastasis (CRLM) were included in the AS group. |
| RS | – | Procedure: liver resection combined with systemic therapyPatients who underwent liver resection combined with systemic therapy for colorectal liver metastasis (CRLM) were included in the RS group. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study included patients with colorectal liver metastases (≤5 lesions, ≤5 cm) who underwent thermal ablation with systemic therapy or liver resection with systemic therapy at four hospitals between January 2018 and April 2023.
Key inclusion criteria (4 listed)
- Age between 18 and 85 years.
- Primary tumor resected with R0 resection and pathological confirmation of colorectal adenocarcinoma.
- Liver metastasis confirmed by any two of the following examinations: contrast-enhanced CT, enhanced MRI, CEUS, PET-CT, or pathology.
- Liver metastases with maximum diameter ≤ 5 cm and ≤ 5 lesions.
Key exclusion criteria (4 listed)
- History of other local treatments for liver metastasis prior to ultrasound-guided microwave ablation/liver resection.
- With concurrent extrahepatic metastases.
- With concurrent other malignancies.
- With incomplete clinical data.
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 |
|---|---|---|
| ablation combined with systemic therapyltrasound-guided Microwave Ablation was performed using a GE LOGIQ E9 system with a C1-6 transducer, Nanjing Yigao ECO-100A1/ECO-100AL9 microwave device, and ECO-200F/100A6 disposable needles. Sonovue was used for CEUS. Single-needle multi-point ablation was performed for lesions <3 cm, and double-needle ablation for lesions ≥3 cm, with needles ≤2 cm apart. Ablation power was 50-60 W, with a 3-6 min duration per point.Real-time ultrasound guided needle placement to avoid surrounding structures. After ablation, the needle was withdrawn, and the track sealed.Post-procedure, grayscale or CEUS confirmed the ablation coverage with a 5-10 mm safety margin. A follow-up CEUS was performed 1 day later to assess treatment efficacy. Systemic therapy was given for approximately 6 cycles. Patients received systemic therapy 2-4 weeks before or after ablation. Systemic therapy regimens included FOLFOX, XELOX, FOLFIRI, and FOLFOXIRI, with or without bevacizumab or cetuximab. | Procedure or surgery | AS |
| liver resection combined with systemic therapyLaparoscopic Partial Liver Resection：Patients underwent laparoscopic partial liver resection, including exploration for extrahepatic metastases, resection of the liver lesion with surrounding tissue, and placement of a drainage tube. The procedure is performed under CO2 pneumoperitoneum with minimal invasive access via multiple ports. Systemic therapy was given for approximately 6 cycles. Patients received systemic therapy 2-4 weeks before or after liver resection. Systemic therapy regimens included FOLFOX, XELOX, FOLFIRI, and FOLFOXIRI, with or without bevacizumab or cetuximab. | Procedure or surgery | RS |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 1year
Disease progression is defined as the appearance of metastatic tumors outside the liver or local recurrence or new tumors within the liver.The definition of Progression-Free Survival (PFS) is the time from the start of treatment to disease progression or death.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Liver Metastasis (CRLM), run by The First Hospital of Jilin 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 30 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2026.