Ablation With Systemic Therapy vs Liver Resection With Systemic Therapy for Colorectal Liver Metastasis (ASRS-CRLM)

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Liver Metastasis (CRLM)
• Intervention / Treatment: Procedure: ablation combined with systemic therapy; Procedure: liver resection combined with systemic therapy

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 Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130012
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AS; Patients who underwent ablation combined with systemic therapy for colorectal liver metastasis (CRLM) were included in the AS group.	Procedure: ablation combined with systemic therapy; 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.
RS; Patients who underwent liver resection combined with systemic therapy for colorectal liver metastasis (CRLM) were included in the RS group.	Procedure: liver resection combined with systemic therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1year

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: microwave ablation; Colorectal liver metastases; progression-free survival
• Other Study ID Numbers: 2024-HS-142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No