Microwave Ablation for Liver Cancer

(ACCLAIM Trial)

Recruiting at 6 trial locations

Overseen By Research Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Society of Interventional Oncology

Disqualifiers: Respiratory distress, Coagulopathy, Allergic reaction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 27

Duration: 1 day

275 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called microwave ablation to determine its effectiveness in controlling liver cancer by halting the growth of up to three small cancer spots in the liver. The researchers aim to demonstrate that this treatment can prevent cancer progression for at least two years in 90% of patients. Suitable candidates have colorectal cancer that has spread to the liver, with up to three liver tumors, each no larger than 2.5 cm, and possibly up to five small spots in the lungs. As an unphased trial, this study provides patients with a unique opportunity to contribute to cutting-edge research that could lead to new treatment options.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that microwave ablation is safe for liver cancer treatment?

Research has shown that microwave ablation (MWA) is a safe method for treating small liver tumors. One study found that MWA is both safe and effective for liver tumors smaller than 3 cm. Another study demonstrated that this treatment did not affect the bile ducts, which carry bile from the liver. Overall, evidence suggests that MWA is well-tolerated and does not cause major side effects in liver tumor patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Microwave ablation is unique because it offers a minimally invasive approach to treating liver cancer, specifically targeting colorectal cancer metastases in the liver. Unlike traditional treatments like surgical resection or chemotherapy, microwave ablation uses high-frequency microwaves to generate heat and destroy cancer cells directly, minimizing damage to surrounding healthy tissue. Researchers are excited about this technique because it can be performed using FDA-cleared and CE-marked systems, potentially leading to faster recovery times and fewer side effects for patients.

What evidence suggests that microwave ablation is effective for liver cancer?

Research has shown that microwave ablation (MWA) effectively treats liver tumors that have spread from other areas. One study found that MWA better prevents tumor regrowth compared to radiofrequency ablation (RFA). Another study confirmed that MWA is safe and effective for treating liver tumors from colorectal cancer, with no major side effects reported. In this trial, participants will undergo MWA with margin confirmation to assess its effectiveness in managing metastatic liver cancer, focusing on preventing cancer recurrence in the treated area. ^{2 3 6 7 8}

Who Is on the Research Team?

Constantinos Sofocleous, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with colorectal cancer that has spread to the liver, with up to 3 small liver tumors (each ≤2.5 cm). Participants can have a few small lung lesions or lymph nodes and must be in good physical condition (ECOG 0-1). They should not have severe illnesses, uncontrolled bleeding disorders, allergies to IV iodine that can't be managed, active infections, or be pregnant.

Inclusion Criteria

I have up to 3 liver tumors, each no larger than 2.5 cm.

Platelet count >50,000/mm3 (correctable allowed) within 30 days prior to study treatment

Patient has signed a written informed consent for the MWA and participation in the study

Exclusion Criteria

My tumor is close to the central part of my lung.

I cannot lie flat or have trouble breathing when resting.

Patient has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo microwave ablation (MWA) of 1-3 colorectal cancer metastases with margin confirmation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for local tumor progression and hepatic disease-free survival

24 months

Multiple visits (in-person and virtual) over 24 months

Margin Assessment

Assessment of the ablation margin is conducted within 7 days post-MWA and again within 4-8 weeks

4-8 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Microwave Ablation

Trial Overview The ACCLAIM study tests microwave ablation on small liver metastases from colorectal cancer. The goal is to see if this treatment can stop tumor growth for at least two years in 90% of cases without surgery or other interventions.

How Is the Trial Designed?

Group I: Microwave ablation with margin confirmation Experimental Treatment 1 Intervention

Patients who meet the eligibility criteria will undergo microwave ablation (MWA) of 1-3 colorectal cancer metastases with any FDA cleared/CE Marked Microwave Ablation System in accordance with the study site's standard-of-care (SOC) practices.

Microwave Ablation is already approved in United States, European Union for the following indications:

Approved in United States as Microwave Ablation for:

• Colorectal cancer liver metastases
• Unresectable liver lesions
• Small solitary lesions

Approved in European Union as Microwave Ablation for:

• Colorectal cancer liver metastases
• Unresectable liver lesions
• Small solitary lesions

Who Is Running the Clinical Trial?

Society of Interventional Oncology

Lead Sponsor

Trials

3

Recruited

10,000+

Published Research Related to This Trial

Microwave ablation (MWA) using the Thermosphere™ Technology demonstrated a high rate of complete tumor ablation (CA) at 93% for percutaneous and 100% for intraoperative procedures in a study of 60 patients with liver malignancies.

The study found that the ablation zones produced by MWA were predictable and aligned with manufacturer predictions based on animal models, indicating that this treatment is both effective and safe across various liver conditions and surgical approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microwave ablation of liver malignancies: comparison of effects and early outcomes of percutaneous and intraoperative approaches with different liver conditions : New advances in interventional oncology: state of the art. De Cobelli, F., Marra, P., Ratti, F., et al.[2018]

Microwave ablation (MWA) significantly reduces local tumor progression (LTP) rates by 30% compared to radiofrequency ablation (RFA), based on a systematic review of 28 studies involving various patient populations.

Both MWA and RFA show similar overall efficacy and safety outcomes for treating liver cancer, indicating that MWA is at least as safe and effective as RFA, with the added benefit of lower LTP rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microwave ablation compared with radiofrequency ablation for treatment of hepatocellular carcinoma and liver metastases: a systematic review and meta-analysis. Glassberg, MB., Ghosh, S., Clymer, JW., et al.[2022]

Microwave thermoablation (MTA) effectively increases tissue temperature in ex-vivo porcine liver, with significant changes in thermal sensitivity observed during both heating and cooling phases, indicating its potential efficacy in destroying hepatic tumors.

The study utilized dual-energy computed tomography (DECT) imaging to assess temperature changes, revealing that higher temperatures correlate with increased ablation-region conspicuity (ARC), which is crucial for evaluating the effectiveness of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual energy computed tomography thermometry during hepatic microwave ablation in an ex-vivo porcine model. Paul, J., Vogl, TJ., Chacko, A.[2016]

The study evaluated the safety and efficacy of a new 2.45-GHz thermosphere microwave ablation (MWA) system in 18 patients with malignant liver tumors, showing no morbidity or mortality during the procedure.

At 2 weeks post-ablation, 100% tumor destruction was achieved, with spherical ablation zones confirmed by CT scans, indicating effective treatment of the tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic microwave thermosphere ablation of malignant liver tumors: an initial clinical evaluation. Berber, E.[2019]

Microwave thermosphere ablation (MTA) demonstrated improved local tumor control in patients with colorectal liver metastasis (CRLM), showing a lower local recurrence rate of 10% compared to 20% for radiofrequency ablation (RFA).

MTA also significantly reduced total ablation and operative times (19 minutes for MTA vs. 37 minutes for RFA), while maintaining similar hospital stays and morbidity rates, indicating it may be a more efficient treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of microwave thermosphere versus radiofrequency thermal ablation in the treatment of colorectal liver metastases. Takahashi, H., Kahramangil, B., Kose, E., et al.[2019]

Microwave thermosphere ablation (MTA) demonstrated a remarkable 99.3% complete tumor destruction rate in a study of 53 patients with malignant liver tumors, indicating its high efficacy.

The procedure was safe, with only an 11.3% morbidity rate and no reported mortality, suggesting that MTA is a feasible option for treating liver tumors laparoscopically.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic microwave thermosphere ablation of malignant liver tumors: An analysis of 53 cases. Zaidi, N., Okoh, A., Yigitbas, H., et al.[2016]

In a study of 100 patients undergoing microwave thermosphere ablation for malignant liver tumors, the procedure showed a low local recurrence rate of 6.6% per lesion, indicating effective short-term tumor control.

The study found that tumor size greater than 3 cm and tumor type were significant predictors of local recurrence, with no recurrences observed in patients with neuroendocrine liver metastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local recurrence after microwave thermosphere ablation of malignant liver tumors: results of a surgical series. Takahashi, H., Kahramangil, B., Berber, E.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9123066/

Multi-institutional analysis of outcomes for thermosphere ... Thermosphere™-Microwave ablation is a safe and effective treatment for colorectal liver metastases with no registered biliary complications in ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/02656736.2022.2077991

Full article: Long-term outcomes following percutaneous ... [Citation27] reported a median overall survival of 36 months following RFA of colorectal cancer liver metastases which is comparable to the ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2210740123001079

Efficacy of microwave ablation versus radiofrequency ... The results of meta-analysis showed that local tumor progression in MWA group was significantly lower than that in RFA group (P < 0.05).

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1473780/full

Comparative efficacy of microwave ablation and ... This research systematically reviews the literature to compare the effectiveness of MWA and RFA in treating liver metastases in the short term.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12245683/

Comparative outcomes of combined thermal ablation and ... A comparison of microwave thermosphere versus radiofrequency thermal ablation in the treatment of colorectal liver metastases. HPB (Oxford) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8909068/

Microwave Ablation for Colorectal Liver Metastases (4) Conclusions: Surgical MWA treatment for CRLM smaller than 3 cm is a safe and valid option. This approach can be safely included for selected ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1365182X18308359

A comparison of microwave thermosphere versus ... The results of the current study showed that for colorectal liver metastases treated with MTA versus RFA, local tumor control rate was better, despite ...

8. link.springer.com link.springer.com/article/10.1007/s00270-023-03481-3

Safety and Efficacy of Percutaneous Liver Microwave ... Eighty-seven liver tumors (65 metastases and 22 hepatocellular carcinomas) measuring 17.8 ± 7.9 mm were treated in 68 patients. Ablation zones ...