Ablation With Systemic Therapy vs Liver Resection With Systemic Therapy for Colorectal Liver Metastasis

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.

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Key information

Conditions

Colorectal Liver Metastasis (CRLM)

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Hospital of Jilin University

Changchun, Jilin, 130012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

ablation combined with systemic therapy

Procedure

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 therapy

Procedure

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Official study title

Outcomes of Ablation With Systemic Therapy vs Liver Resection With Systemic Therapy in Colorectal Liver Metastasis: A Multi-center Retrospective Cohort Study

Acronym: ASRS-CRLM

Important dates

Study start: 2018
Primary completion: 2025
Study completion: 2025
First posted: Apr 30, 2026
Registry last updated: Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed