TACE + SBRT for Liver Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new combination treatment for liver cancer patients awaiting a liver transplant. Researchers aim to determine if using both Transarterial Chemoembolization (TACE), which delivers chemotherapy directly to the liver, and Stereotactic Body Radiation Therapy (SBRT) can manage cancer more effectively than TACE alone. The trial is open to those diagnosed with hepatocellular carcinoma, listed or recommended for a liver transplant, and who have not undergone prior liver radiation or certain other treatments. Participants will be divided into two groups: one receiving only TACE and the other receiving TACE combined with SBRT. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future liver cancer treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using TACE (a treatment that delivers chemotherapy directly to the liver) with SBRT (a precise form of radiation therapy) is generally safe for treating liver cancer. Studies have found that SBRT alone works well and usually doesn't cause severe side effects. TACE is already a common treatment for liver cancer, making it well-known and widely used.

When combined, early research suggests these treatments might still be safe, but more studies are needed to confirm this. In past studies, patients did not experience serious side effects, indicating the treatments were well-tolerated. Overall, the current evidence is promising, but future research must further explore this combination to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Transarterial Chemoembolization (TACE) with Stereotactic Body Radiation Therapy (SBRT) for liver cancer because it offers a potentially more powerful approach than TACE alone. TACE is a standard treatment that targets tumors by cutting off their blood supply and delivering chemotherapy directly to the liver. The addition of SBRT, which delivers precise, high doses of radiation to the tumor, may enhance the effectiveness by directly attacking cancer cells with minimal impact on surrounding healthy tissue. This combination could lead to better tumor control and improved outcomes for patients, making it an intriguing option for advancing liver cancer treatment.

What evidence suggests that this trial's treatments could be effective for liver cancer?

This trial will compare the effectiveness of TACE alone with TACE combined with SBRT for treating liver cancer. Studies have shown that using TACE and SBRT together can be effective, with research indicating that patients who received both treatments had good long-term survival rates. SBRT helps prevent the cancer from growing or spreading without causing serious side effects. Adding SBRT to TACE can enhance the treatment's effectiveness. This combination offers a promising option for patients with liver cancer. ^{2 4 6 7 8}

Who Is on the Research Team?

Edgar Ben-Josef, MD

Principal Investigator

Abramson Cancer Center at Penn Medicine

Tarita Thomas, MD, PhD

Principal Investigator

Loyola University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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]

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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12062511/

Long‐Term Survival and Prognostic Factors of Stereotactic ... Our study provides evidence supporting the effectiveness and safety of combining TACE and SBRT as a treatment strategy for patients with large liver tumors due ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167814024042762

Meta-analysis Comparison of stereotactic body ... Careful assessment of liver function before and after treatment may make SBRT an effective treatment option for patients with HCC of any stage. Large ...

3. thegreenjournal.com thegreenjournal.com/article/S0167-8140(24)04276-2/abstract

Systematic review and meta‐analysis Compared to TACE, SBRT showed a comparable OS and improved LC without serious toxicity. Therefore, SBRT should be considered an effective treatment option for ...

4. redjournal.org redjournal.org/article/S0360-3016(23)00308-5/fulltext

Outcomes From a Multicenter, Randomized, Phase 2 Trial ... Transarterial chemoembolization with drug-eluting beads versus stereotactic body radiation therapy for hepatocellular carcinoma.

5. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2021.653141/full

Efficacy of Stereotactic Body Radiotherapy in Patients With ... The aim of this prospective observational trial was to evaluate the efficacy, toxicity and quality of life after stereotactic body radiation ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12468452/

Safety of Combination TARE and SBRT in Hepatocellular ... These findings suggest that combining TARE and SBRT might be safe and effective, however larger sample and prospective studies need to be ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03895359

Transarterial Chemoembolization (TACE) Versus ... Trans-arterial chemoembolization (TACE) is a standard treatment for patients with hepatocellular carcinoma (also called liver cancer).

8. sciencedirect.com sciencedirect.com/science/article/pii/S2405630824001551

Long-term outcomes of more than a decade treating ... SBRT resulted in excellent long-term local control rates and absence of severe toxicity in a group of HCC patients.