Microwave ablation for colorectal liver metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international clinical trial aims to establish microwave ablation (MWA) as a preferred curative therapy for selected colorectal liver metastases (CLM) that can be effectively treated with sufficient margins. The study will enroll approximately 275 subjects with one to three CLMs, each measuring up to 2.5 cm, and will assess the effectiveness of MWA in achieving a local progression-free survival rate of at least 90% over two years. The procedure will involve creating a minimum ablation margin of 5.0 mm around the tumors, with confirmation of the ablation zone assessed through imaging. The trial will utilize FDA cleared or CE Marked MWA devices and will be conducted across multiple centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient must be at least 18 years old.
2. Patient has signed a written informed consent for the MWA and participation in the study.
3. Patient with pathologically confirmed CRC with hepatic metastases confirmed on imaging (e.g., CT or MRI).
4. Patient has up to 3 hepatic metastases, each up to 2.5 cm in largest diameter.
5. Patient may have up to 5 lesions in the lung (none larger than ≥ 2.0 cm) and/or any lymph node ≤2.0 cm in the largest diameter
6. Ability to safely create an ablation zone (AZ) that completely covers the tumor with minimal margin of 5.0 mm. Subcapsular (any tumor within 10 mm from the liver capsule) or perivascular (any tumor within 10 mm from a vessel larger than 3 mm) lesions may be included. For these tumors, the calculation of the margin will not apply to the area abutting the capsule or the vessel.
7. The target tumor(s) is/are visible by US and/or CT in a location where MWA is technically achievable and safe based on the proximity to adjacent structures. Protective maneuvers such as hydrodissection for organ mobilization are allowed and will be recorded.
8. ECOG performance status of 0-1.
9. Platelet count \>50,000/mm3 (correctable allowed) within 30 days prior to study treatment.

Exclusion Criteria:

1. Patient is unable to lie flat or has respiratory distress at rest.
2. Patient has uncontrolled and uncorrectable coagulopathy or bleeding disorders.
3. Patient has a history of an allergic reaction to intravenous iodine that cannot be pre-medicated or prevents performance of a CT with IV contrast.
4. Patient has evidence of active systemic infection.
5. Patient has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up.
6. Patient is currently participating in other experimental studies that could affect the primary endpoint.
7. Patient unable to receive general anesthesia or adequate analgesia and sedation.
8. Tumor location less than 25 mm from hilum (see diagrams with illustration of central ducts).
9. Patient is currently pregnant or intends to become pregnant

Where it's running

• Miami Cancer Institute
  Miami, Florida, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• Medical College of WI
  Milwaukee, Wisconsin, United States Recruiting
• National and Kapodistrian University of Athens (NKUA)
  Athens, Greece Recruiting

Study contacts

• Principal investigator: Constantinos Sofocleous, MD, PhD, FSIR, FCIRSE — Memorial Sloan Kettering Cancer Center
• Study coordinator: Research Manager
• Email: ACCLAIM@SIO-central.org
• Phone: 202-367-1164

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Multimodal Survival Predictor for Colorectal Liver Metastases After Surgery

  Researchers are testing a tool that combines MRI-derived tumor features with clinical data to predict survival after surgery for colorectal liver metastases.

  Recruiting Anhui Provincial Hospital · Hefei, Anhui · NCT07830576

• Liver transplant vs removal of liver tumors after conversion therapy for initially unresectable colorectal liver metastases

  This trial tests whether liver transplantation or liver surgery with ablation best helps people whose colorectal liver metastases were initially unresectable but became potentially resectable after conversion therapy.

  Recruiting Niguarda Hospital · Milan · NCT07607873

• Paclitaxel liver-artery infusion plus standard chemo for first-line colorectal liver metastases

  This trial will see if giving paclitaxel cationic liposome into the liver artery together with standard first-line chemotherapy (oxaliplatin and capecitabine, with or without bevacizumab) helps people with inoperable colorectal liver metastases.

  Recruiting Phase 1 CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Lishui, Zhejiang · NCT07117435

• Combining ivonescimab with chemotherapy for treating colorectal cancer liver metastases

  This study is testing if adding ivonescimab to chemotherapy can help people with colorectal cancer that has spread to the liver feel better and improve their treatment results.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing · NCT06848842

• Adjuvant FOLFIRI after surgery for colorectal liver metastases that responded to preoperative FOLFIRI

  This trial tests whether giving FOLFIRI chemotherapy after liver surgery helps people whose colorectal liver metastases responded to preoperative FOLFIRI and who could not receive oxaliplatin.

  Recruiting Phase 3 Assistance Publique - Hôpitaux de Paris · Paris, Île-de-France Region · NCT06501482

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.