Stereotactic Liver Ablation for Liver Cancer

Overseen By Bruno Odisio, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Infections, Coagulopathy, Pregnancy, ASA score ≥ 4, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using other local therapies at the target tumor, you may not be eligible to participate.

What data supports the effectiveness of the treatment Stereotactic Liver Ablation for Liver Cancer?

Research shows that stereotactic ablative radiotherapy (SABR) is a safe and effective treatment for liver cancer, particularly for patients who cannot undergo surgery. Studies have demonstrated its success in treating both primary liver cancer and metastatic liver tumors, improving outcomes for patients who have limited treatment options. ^{1 2 3 4 5}

Is stereotactic liver ablation safe for humans?

Microwave ablation (MWA) and radiofrequency ablation (RFA) are generally considered safe for treating liver tumors, with low rates of complications. However, rare complications can include liver abscess, hematoma (a collection of blood outside of blood vessels), pleural effusion (fluid around the lungs), and thermal injury to nearby organs. Serious complications like gastrointestinal injuries are very rare but may require surgery. ^{6 7 8 9 10}

How is stereotactic liver ablation different from other liver cancer treatments?

Stereotactic liver ablation, particularly using stereotactic ablative radiotherapy (SABR), is unique because it is a non-surgical treatment that precisely targets liver tumors with high doses of radiation, making it suitable for patients who cannot undergo surgery. It is a relatively new option that offers a safe and effective alternative for treating liver cancer, especially for those with small tumors or who are not candidates for other local therapies. ^{1 2 3 5 11}

What is the purpose of this trial?

This trial investigates a high-precision liver ablation technique for patients with colorectal liver metastasis. The method uses advanced imaging and computer software to accurately target and destroy tumors, ensuring complete treatment.

Research Team

Bruno Odisio, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

The STEREOLAB trial is for adults over 18 with up to five liver tumors from colorectal cancer, each no larger than 5 cm. They must be able to undergo a precise ablation treatment and have a life expectancy of more than a year. Participants need good kidney function, no severe iodine allergies, and can't be too close to vital bile ducts or severely ill based on specific health scores.

Inclusion Criteria

I have up to 5 liver tumors from colorectal cancer, each no larger than 5 cm, and am referred for a specific tumor-removal procedure.

My bile duct condition is more than 1 cm away from the central bile ducts.

I am older than 18 years.

Exclusion Criteria

I do not have an active bacterial or fungal infection.

I have used other treatments directly on my tumor.

My blood does not clot properly and cannot be corrected.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a high-precision liver ablation procedure using stereotactic-guidance, CT during hepatic arteriography-based imaging analysis, and computer-based software assessment of ablation margins

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, liver function, and overall oncological outcomes, including disease-free and overall survival

1 year

Treatment Details

Interventions

• Liver ablation

Trial Overview This study tests a high-precision liver ablation technique using stereotactic guidance, CT imaging during hepatic arteriography, and software for assessing if the tumor's been fully treated. It aims to see how well this combined method works in treating primary and secondary liver cancers.

Participant Groups

Group I: Liver ablation Experimental Treatment 1 Intervention

The ablation procedure will be performed in 1 day

Liver ablation is already approved in European Union, United States, Switzerland for the following indications:

Approved in European Union as Liver ablation for:

• Primary liver cancer
• Secondary liver cancer
• Hepatocellular carcinoma (HCC)
• Colorectal liver metastases (CRLM)

Approved in United States as Liver ablation for:

• Primary liver cancer
• Secondary liver cancer
• Hepatocellular carcinoma (HCC)
• Colorectal liver metastases (CRLM)

Approved in Switzerland as Liver ablation for:

• Primary liver cancer
• Secondary liver cancer
• Hepatocellular carcinoma (HCC)
• Colorectal liver metastases (CRLM)

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

Stereotactic ablative body radiotherapy (SABR) demonstrated excellent local control and overall survival rates in 63 patients with untreated solitary hepatocellular carcinoma (HCC), with 1-, 2-, and 3-year survival rates of 100%, 87%, and 73%, respectively.

Despite being unfit for surgical resection or ablation, patients treated with SABR experienced manageable safety profiles, with only a few cases of grade 3 toxicities and one instance of ascites, suggesting that SABR is a safe and effective alternative treatment for HCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy for previously untreated solitary hepatocellular carcinoma. Takeda, A., Sanuki, N., Eriguchi, T., et al.[2022]

Stereotactic ablative radiotherapy (SABR) has emerged as a safe and effective non-surgical treatment option for patients with oligometastatic liver disease, addressing the need for alternatives since 80%-90% of these patients are not eligible for surgery.

Current evidence supports the use of SABR, although optimal treatment parameters such as dose-fractionation schemes and patient selection strategies are still being investigated to maximize outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of metastatic liver tumors using stereotactic ablative radiotherapy. Nair, VJ., Pantarotto, JR.[2021]

In a study of 117 patients with small hepatocellular carcinoma (HCC), stereotactic ablative radiation therapy (SABR) showed similar overall survival (OS) and progression-free survival (PFS) rates compared to liver resection, indicating comparable efficacy for treating small HCCs.

SABR was associated with fewer complications, such as hepatic hemorrhage and pain, making it a less invasive option than liver resection, although it did result in more acute nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Survival Analysis of Stereotactic Ablative Radiotherapy Versus Liver Resection for Small Hepatocellular Carcinoma. Su, TS., Liang, P., Liang, J., et al.[2018]

Stereotactic Ablative Body Radiotherapy (SABR) is an effective non-invasive treatment for small inoperable liver metastases, showing a high local control rate of 92% at 6 months and 57% at 1 and 2 years, with a median overall survival of 12 months for 19 patients studied.

The study found that higher doses (BED2 > 78 Gy) improved local control, particularly in smaller tumors (PTV sizes < 67 cm3), while maintaining low toxicity levels, with no acute toxicity greater than grade 2 and only one late toxicity incident reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated image-guided breath-hold SABR (stereotactic ablative body radiotherapy) of liver metastases--clinical results. Boda-Heggemann, J., Dinter, D., Weiss, C., et al.[2021]

Stereotactic ablative body radiotherapy (SABR) demonstrated a high local control rate of 90% in treating hepatocellular carcinoma (HCC) in a cohort of 28 patients, indicating its efficacy as a treatment option for inoperable cases.

SABR was found to be safe, with 46% of patients experiencing mild toxicity (grade 1 or 2) and only 14% requiring hospitalization (grade 3), suggesting it can be administered even after previous liver-directed therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival and morbidity following stereotactic radiotherapy of hepatocellular carcinoma: a ten-year, single institution experience. Mortensen, HR., Villadsen, GE., Worm, ES., et al.[2022]

Microwave ablation (MWA) is generally a safe and effective method for treating liver tumors, but this case highlights a rare complication of gastric perforation following the procedure.

In this instance, the gastric perforation was managed conservatively, and the patient successfully underwent liver transplantation nine months later, indicating that while complications can occur, they can sometimes be effectively treated without immediate surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conservative treatment of gastric perforation after microwave ablation of a hepatocellular carcinoma: Case report. Roller, J., Zimmer, V., Bücker, A., et al.[2023]

Microwave ablation (MWA) is a safe and effective treatment for liver tumors located near important organs, with no significant difference in complications or local tumor recurrence (LTR) compared to tumors in less risky locations, based on a study of 109 patients.

Factors influencing LTR include tumor size (with tumors larger than 3 cm increasing the risk by over three times) and the quality of lipiodol deposition, which can decrease the risk of recurrence by 73.4%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications and local recurrence of malignant liver tumor after ablation in risk areas: a retrospective analysis. Yang, D., Yang, J., Zhu, F., et al.[2023]

In a meta-analysis of 26 studies involving over 4000 patients, percutaneous radiofrequency ablation (RFA) was found to have significantly lower rates of both minor and major complications compared to microwave ablation (MWA) for treating liver tumors.

Despite the differences in complication rates, both RFA and MWA showed no significant difference in local recurrence rates after treatment, indicating that both methods are effective for managing liver tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complication Rates and Risk of Recurrence After Percutaneous Radiofrequency Ablation and Microwave Ablation for the Treatment of Liver Tumors: a Meta-analysis. Alhasan, AS., Daqqaq, TS., Alhasan, MS., et al.[2023]

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]

Radiofrequency ablation (RFA) is a standard treatment for early hepatocellular carcinoma (HCC) with a low incidence of adverse events (2.4% to 13.1%), but gastrointestinal tract (GIT) injuries, although rare (0.11%), can occur and may require surgical intervention.

This case report presents the first successful treatment of RFA-related GIT injury using an over-the-scope clip (OTSC), demonstrating a new endoscopic approach to manage this serious complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal tract injuries after thermal ablative therapies for hepatocellular carcinoma: A case report and review of the literature. Rogger, TM., Michielan, A., Sferrazza, S., et al.[2021]

Stereotactic ablative radiotherapy (SABR) demonstrated a high rate of complete pathological response (61.5%) in hepatocellular carcinoma (HCC) lesions prior to liver transplantation, indicating its effectiveness as a bridging therapy.

SABR was found to be a safe treatment option, with manageable toxicities; however, further prospective trials are necessary to compare its efficacy against other local therapies for HCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiation therapy prior to liver transplantation in hepatocellular carcinoma. Guarneri, A., Franco, P., Romagnoli, R., et al.[2018]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy for previously untreated solitary hepatocellular carcinoma. [2022]

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

Treatment of metastatic liver tumors using stereotactic ablative radiotherapy. [2021]

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

Long-Term Survival Analysis of Stereotactic Ablative Radiotherapy Versus Liver Resection for Small Hepatocellular Carcinoma. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Hypofractionated image-guided breath-hold SABR (stereotactic ablative body radiotherapy) of liver metastases--clinical results. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Survival and morbidity following stereotactic radiotherapy of hepatocellular carcinoma: a ten-year, single institution experience. [2022]

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

Conservative treatment of gastric perforation after microwave ablation of a hepatocellular carcinoma: Case report. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Complications and local recurrence of malignant liver tumor after ablation in risk areas: a retrospective analysis. [2023]

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

Complication Rates and Risk of Recurrence After Percutaneous Radiofrequency Ablation and Microwave Ablation for the Treatment of Liver Tumors: a Meta-analysis. [2023]

9. England pubmed.ncbi.nlm.nih.gov

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

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

Gastrointestinal tract injuries after thermal ablative therapies for hepatocellular carcinoma: A case report and review of the literature. [2021]

11. Italy pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiation therapy prior to liver transplantation in hepatocellular carcinoma. [2018]