TACE + SBRT for Liver Cancer

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Disqualifiers: Prior radiotherapy, Active GI bleed, Ascites, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

40 Participants Needed

Trial Summary

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

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

What data supports the effectiveness of the treatment TACE + SBRT for liver cancer?

Research shows that combining TACE (a procedure that blocks blood supply to the tumor) with SBRT (a precise form of radiation therapy) can improve survival rates and control tumor growth in patients with liver cancer that cannot be surgically removed. ^{1 2 3 4 5}

Is the combination of TACE and SBRT safe for treating liver cancer?

The combination of TACE (transarterial chemoembolization) and SBRT (stereotactic body radiotherapy) has been evaluated for safety in treating liver cancer, with studies indicating it is generally safe, though rare complications like biliary issues (problems with the bile ducts) can occur. ^{1 3 5 6 7}

How is the TACE + SBRT treatment for liver cancer different from other treatments?

The TACE + SBRT treatment is unique because it combines transarterial chemoembolization (TACE), which delivers chemotherapy directly to the liver tumor through the blood vessels, with stereotactic body radiation therapy (SBRT), a precise form of radiation that targets the tumor. This combination aims to enhance the effectiveness of treatment for liver cancer that cannot be surgically removed. ^{1 2 8 9 10}

What is the purpose of this trial?

This trial is designed to be the initial prospective pilot investigation of the effectiveness of combined SBRT and TACE as bridging therapy for HCC patients awaiting liver transplanation. No prospective clinical trials regarding the combination of TACE and SBRT in pre-transplant population have been performed. We propose the trial be conducted as a pilot clinical trial with the goal of enrolling 40 patients into each arm

Research Team

Edgar Ben-Josef, MD

Principal Investigator

Abramson Cancer Center at Penn Medicine

Tarita Thomas, MD, PhD

Principal Investigator

Loyola University

Eligibility Criteria

This trial is for adults over 18 with hepatocellular carcinoma who are on or recommended for a liver transplant list. They should be able to undergo TACE, have Childs' Class A or B7 liver function, and an ECOG performance status of 0 or 1. Pregnant women, those in other treatment studies, with certain medical conditions like active GI ulcers or bleeds, prior upper abdomen radiotherapy or liver treatments are excluded.

Inclusion Criteria

I am older than 18 years.

I am eligible for a specific liver cancer treatment as per my radiologist.

I am able to understand and agree to the study's procedures and risks.

Exclusion Criteria

I have had TACE, RFA, or a liver transplant for my liver lesion.

I cannot have MRI or CT scans with contrast due to health reasons.

Blood flow in the vein to part of my liver with the cancer is completely blocked.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TACE alone or TACE combined with SBRT as bridging therapy for HCC

10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Stereotatic Body Radiotherapy (SBRT)
• Transarterial Chemoembolization (TACE)

Trial Overview The study is testing if combining two treatments—TACE and SBRT—is effective as a temporary solution (bridging therapy) for patients with liver cancer waiting for a transplant. It's the first study of its kind and aims to enroll 40 patients into each treatment group.

Participant Groups

Group I: B - Tace combined with SBRT Experimental Treatment 2 Interventions

B- TACE combined with SBRT (experimental group).

Group II: A -Tace alone Experimental Treatment 1 Intervention

A - TACE alone (control group, current practice and treatment)

Transarterial Chemoembolization (TACE) is already approved in European Union, United States, China, Japan for the following indications:

Approved in European Union as TACE for:

• Hepatocellular carcinoma (HCC)
• Liver cancer

Approved in United States as TACE for:

• Hepatocellular carcinoma (HCC)
• Liver cancer

Approved in China as TACE for:

• Hepatocellular carcinoma (HCC)
• Liver cancer

Approved in Japan as TACE for:

• Hepatocellular carcinoma (HCC)
• Liver cancer

Who Is Running the Clinical Trial?

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Loyola University

Collaborator

Trials

161

Recruited

31,400+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

Findings from Research

In a study of 57 patients with BCLC stage B hepatocellular carcinoma, the combination of trans-arterial chemoembolization (TACE) and stereotactic body radiation therapy (SBRT) resulted in a high objective response rate of 85.9% and a local control rate of 91.1% at one year, indicating strong efficacy for this treatment approach.

The treatment was well tolerated, with only 1.8% of patients experiencing severe gastrointestinal toxicity, suggesting that TACE followed by SBRT is a safe option for patients who cannot undergo surgery or radiofrequency ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Prognostic Factors of Trans-Arterial Chemoembolization Combined With Stereotactic Body Radiation Therapy for BCLC Stage B Hepatocellular Carcinoma. Jiang, C., Jing, S., Zhou, H., et al.[2022]

In a study of 49 patients receiving transarterial chemoembolization (TACE) combined with stereotactic body radiation therapy (SBRT), overall survival rates were significantly better compared to 98 patients receiving TACE alone, with 1-year survival rates of 67.2% versus 43.9%.

The combination of TACE and SBRT also improved progression-free survival rates and radiological disease control, while showing a low risk of severe treatment-related toxicity, indicating it is a safe and effective option for patients with nonresectable hepatocellular carcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Better survival after stereotactic body radiation therapy following transarterial chemoembolization in nonresectable hepatocellular carcinoma: A propensity score matched analysis. Wong, TC., Chiang, CL., Lee, AS., et al.[2019]

In a study of 72 patients with advanced hepatocellular carcinoma (HCC), combining trans-arterial chemoembolization (TACE) with stereotactic body radiotherapy (SBRT) resulted in a high objective response rate of 68% and a 1-year local control rate of 93.6%.

The treatment was found to be safe, with only 2.8% of patients experiencing severe gastrointestinal side effects and no cases of classical radiation-induced liver injury, suggesting that this combination therapy can be a viable initial treatment option for selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined stereotactic body radiotherapy and trans-arterial chemoembolization as initial treatment in BCLC stage B-C hepatocellular carcinoma. Chiang, CL., Chan, MKH., Yeung, CSY., et al.[2020]

In a pilot study of 28 patients with small hepatocellular carcinoma (HCC), the combination of transcatheter arterial chemoembolization (TACE) followed by stereotactic body radiation therapy (SBRT) achieved a remarkable 1-year local tumor control rate of 96.3%.

The treatment was found to be safe, with no severe acute toxicity reported, and resulted in a median disease-free survival of 18 months and a 1-year overall survival rate of 92.6%, indicating its efficacy as a locoregional therapy for small HCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of stereotactic body radiation therapy combined with transcatheter arterial chemoembolization for small hepatocellular carcinoma. Honda, Y., Kimura, T., Aikata, H., et al.[2022]

In a meta-analysis of 9 studies involving 938 patients, the combination of stereotactic body radiotherapy (SBRT) and transcatheter arterial chemoembolization (TACE) significantly improved 1-year and 2-year overall survival rates compared to either treatment alone for patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombus (PVTT).

The combination therapy also resulted in a higher objective response rate and a lower progression disease rate, with no significant increase in adverse events compared to monotherapy, suggesting it is a safe and effective treatment option for inoperable HCC patients with PVTT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy plus transcatheter arterial chemoembolization for inoperable hepatocellular carcinoma patients with portal vein tumour thrombus: A meta-analysis. Zhang, XF., Lai, L., Zhou, H., et al.[2022]

In a study of 168 patients with hepatocellular carcinoma who underwent 305 transarterial chemoembolization (TACE) procedures, biliary complications occurred in only 3.6% of patients, indicating that such complications are infrequent.

The types of biliary complications included minimal intrahepatic biliary dilatation, biliary stricture, and intrahepatic biloma, with treatment varying based on severity, highlighting the importance of clinical suspicion and imaging for diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biliary complications of arterial chemoembolization of hepatocellular carcinoma. Dhamija, E., Paul, SB., Gamanagatti, SR., et al.[2015]

A meta-analysis of 10 studies involving 980 patients found that combining stereotactic body radiotherapy (SBRT) with transcatheter arterial chemoembolization (TACE) significantly improves overall survival and disease control rates compared to SBRT alone for treating unresectable hepatocellular carcinoma (HCC).

While the combination therapy (SBRT + TACE) showed better efficacy, it was associated with a higher incidence of leukopenia and fever, indicating the need for careful monitoring of these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy Combined with Transcatheter Arterial Chemoembolization versus Stereotactic Body Radiotherapy Alone as the First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Meta-Analysis and Systematic Review. Zhao, J., Zeng, L., Wu, Q., et al.[2020]

In a study of 68 patients with small, solitary, hypervascular hepatocellular carcinoma (HCC), combining stereotactic body radiation therapy (SBRT) with transcatheter arterial chemoembolization (TACE) resulted in a complete response in 96.3% of patients, compared to only 3.3% in the TACE-only group, highlighting the efficacy of the combination treatment.

The combination therapy was found to be safe, with no patients experiencing severe acute hematologic toxicity or radiation-induced liver damage, and it significantly improved disease-free survival (15.7 months vs 4.2 months) for patients without previous HCC treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy combined with transcatheter arterial chemoembolization for small hepatocellular carcinoma. Honda, Y., Kimura, T., Aikata, H., et al.[2022]

In a study of 103 patients with unresectable hepatocellular carcinoma, combining drug eluting bead transarterial chemoembolization (DEB-TACE) with stereotactic body radiation therapy (SBRT) resulted in a high objective response rate, with 62.1% achieving a complete response and 26.3% a partial response.

Patients who received planned adjuvant SBRT after DEB-TACE had significantly better outcomes compared to those who received salvage SBRT, suggesting that this combination therapy could be an effective strategy for improving local control and overall survival in liver cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy following transarterial chemoembolization for unresectable hepatocellular carcinoma. Buckstein, M., Kim, E., Fischman, A., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Prognostic Factors of Trans-Arterial Chemoembolization Combined With Stereotactic Body Radiation Therapy for BCLC Stage B Hepatocellular Carcinoma. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Better survival after stereotactic body radiation therapy following transarterial chemoembolization in nonresectable hepatocellular carcinoma: A propensity score matched analysis. [2019]

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

Combined stereotactic body radiotherapy and trans-arterial chemoembolization as initial treatment in BCLC stage B-C hepatocellular carcinoma. [2020]

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

Long-term survival analysis in combined transarterial embolization and stereotactic body radiation therapy versus stereotactic body radiation monotherapy for unresectable hepatocellular carcinoma >5 cm. [2022]

5. Greece pubmed.ncbi.nlm.nih.gov

Pilot study of stereotactic body radiation therapy combined with transcatheter arterial chemoembolization for small hepatocellular carcinoma. [2022]

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

Stereotactic body radiotherapy plus transcatheter arterial chemoembolization for inoperable hepatocellular carcinoma patients with portal vein tumour thrombus: A meta-analysis. [2022]

7. France pubmed.ncbi.nlm.nih.gov

Biliary complications of arterial chemoembolization of hepatocellular carcinoma. [2015]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy Combined with Transcatheter Arterial Chemoembolization versus Stereotactic Body Radiotherapy Alone as the First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Meta-Analysis and Systematic Review. [2020]

9. Australia pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy combined with transcatheter arterial chemoembolization for small hepatocellular carcinoma. [2022]

10. China pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy following transarterial chemoembolization for unresectable hepatocellular carcinoma. [2022]