Thermal Ablation for Colon Cancer Liver Metastases

Overseen By Efsevia Vakiani, MD,PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Age < 18, More than 3 tumors, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on Coumadin, general clinical guidelines for the procedure will be followed, which might involve adjustments.

What data supports the effectiveness of the treatment Thermal Ablation for Colon Cancer Liver Metastases?

Research shows that thermal ablation, including microwave ablation, is an effective treatment for patients with metastatic colon cancer to the liver, especially for those who cannot undergo surgery. It offers a potential cure for patients with multiple liver metastases, and there is growing evidence supporting its use in managing metastatic colorectal liver disease. ^{1 2 3 4 5}

Is thermal ablation safe for treating liver metastases?

Thermal ablation techniques like microwave ablation (MWA) and radiofrequency ablation (RFA) have been studied for treating liver tumors, including those from colon cancer. While these treatments are generally considered safe, they can have complications such as incomplete tumor cell death and potential spread of cancer cells within the liver or to other parts of the body. ^{2 4 6 7 8}

How is thermal ablation treatment different from other treatments for colon cancer liver metastases?

Thermal ablation is unique because it uses heat to destroy cancer cells in the liver, offering a treatment option for patients who cannot undergo surgery. It includes various methods like microwave and radiofrequency ablation, which can be performed percutaneously (through the skin) and may provide a curative approach for patients with non-resectable liver metastases. ^{1 2 4 9 10}

What is the purpose of this trial?

This study will see whether collecting and analyzing needle biopsy samples from cancer liver metastases after a tumor ablation procedure will be able to identify cancer cells that are still alive. The results of these biopsies could help determine the next treatment for your cancer, but the biopsies could cause side effects.

Research Team

Constantinos Sofocleous, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for people with colorectal cancer that has spread to the liver. They should have at least one lesion visible on a PET scan, a sufficient platelet count, and stable liver or limited extrahepatic disease. The study excludes those who don't meet these criteria.

Inclusion Criteria

My cancer lesion is 3 cm or smaller.

I have been diagnosed with liver metastases from colorectal cancer.

Your blood's ability to clot is not too high.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tumor Ablation and Biopsy

Participants undergo a standard of care tumor ablation procedure followed by post-ablation biopsies and PET scans. If PET scans are positive, additional biopsies are performed, and if cancer cells are detected, immediate retreatment with a second ablation is conducted.

4-6 weeks

Follow-up

Participants are monitored for tumor response and safety using CT and PET scans, with the first scans post-ablation serving as the new baseline for comparison.

2 years

Treatment Details

Interventions

• Thermal ablation (TA)

Trial Overview The study tests if analyzing tissue samples after tumor ablation can detect living cancer cells in the liver. This could guide further treatment decisions. Participants will undergo tumor ablation followed by PET/CT scans.

Participant Groups

Group I: Patients with Liver Metastases Experimental Treatment 3 Interventions

The standard of care tumor ablation procedure, post-ablation biopsies and pre- and post-ablation PET scans. If the PET scan is positive (shows areas of cancer in the treated metastases), study participants will undergo additional needle biopsies of the positive areas on the scan. If the biopsies show areas of cancer cells that are still alive, the participants will be immediately retreated with a second ablation procedure.

Thermal ablation (TA) is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Thermal Ablation for:

• Liver cancer
• Liver metastases

Approved in United States as Thermal Ablation for:

• Liver cancer
• Liver metastases
• Hepatocellular carcinoma

Approved in Canada as Thermal Ablation for:

• Liver cancer
• Liver metastases

Approved in Japan as Thermal Ablation for:

• Liver cancer
• Liver metastases

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

Colorectal cancer (CRC) is a major cause of cancer-related deaths, with liver metastases commonly present at diagnosis, making effective treatment crucial.

Thermal ablation techniques, particularly microwave ablation (MWA), are emerging as important options for managing CRC liver metastases, offering potential benefits for patients who are not candidates for surgical resection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermal Ablation of Metastatic Colon Cancer to the Liver. Camacho, JC., Petre, EN., Sofocleous, CT.[2020]

In a study of 10 patients with five or more colorectal liver metastases treated with microwave ablation (MWA), the procedure demonstrated a median overall survival of 3 years and a disease-free survival of 7.1 months, indicating its efficacy even in high-volume metastatic cases.

The study reported a low per-lesion recurrence rate of 4% at the ablation site, suggesting that MWA can effectively control local disease, although intrahepatic recurrence occurred in 60% of patients, highlighting the need for careful patient selection and follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical microwave ablation for multifocal non-resectable liver metastases: a single institution experience treating five or more liver lesions. Wothe, JK., McEachron, KR., Marmor, S., et al.[2022]

Percutaneous thermal ablation techniques, including radiofrequency ablation, microwave ablation, cryoablation, and MR-guided focused ultrasound, effectively reduced pain in patients with bone metastases, achieving pain relief in up to 91% of patients at 1 month and 95% at 3 months based on a review of 11 studies involving 364 patients.

Microwave ablation demonstrated a negligible complication rate, making it a safer option, while MR-guided focused ultrasound had a higher rate of complications, indicating a need for careful consideration of treatment choice based on safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermal ablation to relieve pain from metastatic bone disease: a systematic review. Gennaro, N., Sconfienza, LM., Ambrogi, F., et al.[2023]

Thermal ablation (TA) therapies, such as microwave coagulation therapy and radiofrequency ablation, achieved a high local tumor control rate of 95% in 105 patients with unresectable liver metastatic lesions, indicating their efficacy in managing colorectal metastasis to the liver.

Combining TA with hepatectomy can increase the chances of making previously inoperable tumors resectable without raising the risk of spreading cancer within the liver or to other parts of the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative thermal ablation therapy for small colorectal metastases to the liver. Ogata, Y., Uchida, S., Hisaka, T., et al.[2008]

In a study of 54 patients treated for colorectal cancer liver metastases using radiofrequency and microwave thermoablations, the local recurrence (LR) rate was found to be 17.5%, highlighting the need for careful assessment of risk factors.

Key risk factors for local recurrence included the size of the lesions and the proximity of nearby blood vessels, indicating that these factors should be considered when planning thermoablative treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive Factors of Local Recurrence after Colorectal Cancer Liver Metastases Thermal Ablation. Odet, J., Pellegrinelli, J., Varbedian, O., et al.[2023]

In a study of 32 patients with colorectal cancer pulmonary metastases, CT-guided microwave ablation (MWA) successfully ablated 87.5% of the lesions, demonstrating its efficacy as a treatment option.

The procedure was found to be safe, with no patient deaths within 30 days and a low complication rate, although pneumothorax occurred in 12.5% of cases; the median survival time post-treatment was 31 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and efficacy of microwave ablation for the treatment of CRC pulmonary metastases. Cheng, G., Shi, L., Qiang, W., et al.[2019]

Microwave thermal ablation (MWA) demonstrated a 100% technical success rate in treating 19 hepatic lesions in 15 inoperable patients, indicating its feasibility as a treatment option.

While MWA achieved complete ablation in 68.4% of cases, treatment failures were noted in 60% of patients, with lesion diameter being a key factor influencing the success of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided microwave ablation of hepatic tumours: preliminary experience. Veltri, A., Gazzera, C., Rotondella, C., et al.[2021]

In a study of 879 patients undergoing thermal ablation for liver tumors, both radiofrequency ablation (RFA) and microwave ablation (MWA) demonstrated low mortality rates of 0.31% and 0.36%, respectively, indicating a high level of safety for these procedures.

The rates of major complications were similar for RFA (3.5%) and MWA (3.1%), as were minor complications (5.9% for RFA and 5.7% for MWA), suggesting that both techniques are comparably safe for treating liver tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of thermal ablation of hepatic tumours: comparison of radiofrequency and microwave ablative techniques. Ding, J., Jing, X., Liu, J., et al.[2013]

In a study of 107 patients with colorectal liver metastases, achieving a biopsy-proven complete tumor ablation with margins of at least 5 mm significantly reduced the risk of local tumor progression (LTP) to just 7% at 12 months.

The study found that LTP was much higher (63%) when the biopsy indicated viable tumor in the ablation zone with margins less than 5 mm, highlighting the importance of adequate margins for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biopsy and Margins Optimize Outcomes after Thermal Ablation of Colorectal Liver Metastases. Vasiniotis Kamarinos, N., Vakiani, E., Gonen, M., et al.[2022]

In a study of 28 patients with colorectal liver metastases treated with thermal ablation, the procedure showed no severe complications and resulted in a median overall survival of 27.5 months, compared to 21.4 months for those receiving chemotherapy alone.

Patients who underwent thermal ablation also experienced a longer median progression-free survival of 19.4 months, indicating that this treatment may effectively delay disease progression compared to chemotherapy alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermal ablation may improve outcomes in patients with colorectal liver metastasis: a case-control study. Poulou, LS., Thanos, L., Ziakas, PD., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Thermal Ablation of Metastatic Colon Cancer to the Liver. [2020]

2. China pubmed.ncbi.nlm.nih.gov

Surgical microwave ablation for multifocal non-resectable liver metastases: a single institution experience treating five or more liver lesions. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Thermal ablation to relieve pain from metastatic bone disease: a systematic review. [2023]

4. Greece pubmed.ncbi.nlm.nih.gov

Intraoperative thermal ablation therapy for small colorectal metastases to the liver. [2008]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Predictive Factors of Local Recurrence after Colorectal Cancer Liver Metastases Thermal Ablation. [2023]

6. England pubmed.ncbi.nlm.nih.gov

The safety and efficacy of microwave ablation for the treatment of CRC pulmonary metastases. [2019]

7. Italy pubmed.ncbi.nlm.nih.gov

Image-guided microwave ablation of hepatic tumours: preliminary experience. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Complications of thermal ablation of hepatic tumours: comparison of radiofrequency and microwave ablative techniques. [2013]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Biopsy and Margins Optimize Outcomes after Thermal Ablation of Colorectal Liver Metastases. [2022]

10. Cyprus pubmed.ncbi.nlm.nih.gov

Thermal ablation may improve outcomes in patients with colorectal liver metastasis: a case-control study. [2019]