128 Participants Needed

TACE + SBRT for Liver Cancer

(TACE Trial)

ML
Overseen ByMichael Lock, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: London Health Sciences Centre OR Lawson Research Institute of St. Joseph's
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Trans-arterial chemoembolization (TACE) is a standard treatment for patients with hepatocellular carcinoma (also called liver cancer). This is where chemotherapy is injected into the arteries of the liver and liver cancer. Unfortunately, the tumour grows after TACE in many patients. A new treatment using a specialized radiation procedure called Stereotactic ablative body radiotherapy (SBRT) may increase the chance to control liver cancer. SBRT allows radiation treatments to be focused more precisely, and be delivered more accurately than with older treatments. The purpose of this study is to find out if TACE alone versus TACE plus SBRT is better for you and your liver cancer.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, chemotherapy must be completed at least 2 weeks before starting radiation therapy or TACE, and it should not be planned for at least 1 week after treatment (4 weeks for certain drugs).

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 for patients with liver cancer that cannot be surgically removed. Studies indicate that this combination may be more effective than using SBRT alone.12345

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

Research shows that combining TACE (a procedure that blocks blood supply to a tumor) and SBRT (a precise form of radiation therapy) is generally safe for treating liver cancer, with few major complications. However, there can be rare biliary (related to bile ducts) complications following TACE.46789

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

The TACE + SBRT treatment for liver cancer is unique because it combines two approaches: TACE, which delivers chemotherapy directly to the liver tumor through the blood vessels, and SBRT, a precise form of radiation therapy that targets the tumor with high doses of radiation. This combination aims to enhance tumor control and improve survival in patients with liver cancer that cannot be surgically removed.124810

Research Team

ML

Michael Lock, M.D.

Principal Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Eligibility Criteria

This trial is for adults with liver cancer, having up to 5 liver lesions and no severe cirrhosis or active hepatitis. They must not have had certain treatments recently, be able to use contraception, and have a life expectancy over 6 months. Those with larger tumors or previous radiation in the same area can't join.

Inclusion Criteria

Life expectancy > 6 months.
My liver cancer can be treated with TACE.
All my liver cancer can be targeted with radiation.
See 14 more

Exclusion Criteria

I have had radiation in the same area where my current cancer is located.
My liver is not severely damaged (Child Pugh ≤ B7).
My health issues do not limit my life expectancy to under 6 months.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Transarterial Chemoembolization (TACE) or TACE plus Stereotactic Body Radiation Therapy (SBRT)

6 weeks
Weekly visits during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years
1 and 3 month follow-up, and every 3 months thereafter

Treatment Details

Interventions

  • Stereotactic Body Radiation Therapy
  • Transarterial Chemoembolization
Trial Overview The study compares standard TACE treatment for liver cancer against TACE combined with SBRT, a precise radiation therapy. It aims to see if adding SBRT better controls the growth of liver tumors after TACE.
Participant Groups
2Treatment groups
Active Control
Group I: Transarterial Chemoembolization (TACE)Active Control1 Intervention
Transarterial Chemoembolization (TACE)
Group II: TACE Plus Stereotactic Body Radiation Therapy (SBRT)Active Control1 Intervention
Stereotactic Body Radiation Therapy (SBRT)

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

🇺🇸
Approved in United States as TACE for:
  • Non-small cell lung cancer
  • Lung metastases
🇨🇳
Approved in China as TACE for:
  • Unresectable lung cancer
  • Advanced lung cancer
🇪🇺
Approved in European Union as TACE for:
  • Non-small cell lung cancer
  • Lung metastases

Find a Clinic Near You

Who Is Running the Clinical Trial?

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
668
Recruited
424,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
686
Recruited
427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
678
Recruited
421,000+

Lawson Health Research Institute

Lead Sponsor

Trials
684
Recruited
432,000+

CancerCare Manitoba

Collaborator

Trials
29
Recruited
5,600+

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.
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.
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 190 patients with inoperable hepatocellular carcinoma (HCC), transarterial chemoembolization combined with thermal ablation (TACE-TA) resulted in significantly better overall survival (77% at 2 years) and progression-free survival (76% at 2 years) compared to TACE with stereotactic body radiotherapy (TACE-SBRT), which had 49% and 50% respectively.
TACE-TA also demonstrated lower rates of treatment-related hepatotoxicity (9%) compared to TACE-SBRT (27%), suggesting that TACE-TA may be a safer option for patients, although both treatments showed similar outcomes for patients with early-stage HCC and preserved liver function.
Thermal Ablation Versus Stereotactic Body Radiotherapy After Transarterial Chemoembolization for Inoperable Hepatocellular Carcinoma: A Propensity Score-Weighted Analysis.Nabavizadeh, N., Jahangiri, Y., Rahmani, R., et al.[2021]

References

Efficacy and Prognostic Factors of Trans-Arterial Chemoembolization Combined With Stereotactic Body Radiation Therapy for BCLC Stage B Hepatocellular Carcinoma. [2022]
Better survival after stereotactic body radiation therapy following transarterial chemoembolization in nonresectable hepatocellular carcinoma: A propensity score matched analysis. [2019]
Thermal Ablation Versus Stereotactic Body Radiotherapy After Transarterial Chemoembolization for Inoperable Hepatocellular Carcinoma: A Propensity Score-Weighted Analysis. [2021]
Combined stereotactic body radiotherapy and trans-arterial chemoembolization as initial treatment in BCLC stage B-C hepatocellular carcinoma. [2020]
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]
Stereotactic body radiotherapy plus transcatheter arterial chemoembolization for inoperable hepatocellular carcinoma patients with portal vein tumour thrombus: A meta-analysis. [2022]
Pilot study of stereotactic body radiation therapy combined with transcatheter arterial chemoembolization for small hepatocellular carcinoma. [2022]
Stereotactic body radiation therapy combined with transcatheter arterial chemoembolization for small hepatocellular carcinoma. [2022]
Biliary complications of arterial chemoembolization of hepatocellular carcinoma. [2015]
Stereotactic body radiation therapy following transarterial chemoembolization for unresectable hepatocellular carcinoma. [2022]