TACE + SBRT for Liver Cancer
(TACE Trial)
Recruiting in Palo Alto (17 mi)
Overseen byMichael Lock, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: London Health Sciences Centre OR Lawson Research Institute of St. Joseph's
Disqualifiers: Severe cirrhosis, Liver failure, Pregnancy, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 3 Jurisdictions
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.
12345Is 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.
46789How 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.
124810Eligibility 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.
+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.
+3 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
London Health Sciences Centre, London Regional Cancer ProgramLondon, Canada
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Who Is Running the Clinical Trial?
London Health Sciences Centre OR Lawson Research Institute of St. Joseph'sLead Sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph'sLead Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sLead Sponsor
Lawson Health Research InstituteLead Sponsor
CancerCare ManitobaCollaborator
References
Efficacy and Prognostic Factors of Trans-Arterial Chemoembolization Combined With Stereotactic Body Radiation Therapy for BCLC Stage B Hepatocellular Carcinoma. [2022]This study aimed to evaluate the efficacy and safety of trans-arterial chemoembolization (TACE) followed by stereotactic body radiation therapy (SBRT) in treating Barcelona Clinic Liver Cancer (BCLC) stage B hepatocellular carcinoma (HCC) not amenable to resection and radiofrequency ablation (RFA).
Better survival after stereotactic body radiation therapy following transarterial chemoembolization in nonresectable hepatocellular carcinoma: A propensity score matched analysis. [2019]This study compared outcomes of nonresectable hepatocellular carcinoma (HCC) who had transarterial chemoembolization (TACE) vs. stereotactic body radiation therapy (SBRT) after TACE (TACE + SBRT).
Thermal Ablation Versus Stereotactic Body Radiotherapy After Transarterial Chemoembolization for Inoperable Hepatocellular Carcinoma: A Propensity Score-Weighted Analysis. [2021]BACKGROUND. Transarterial chemoembolization (TACE) has synergistic properties when combined with ablative therapies for hepatocellular carcinoma (HCC). OBJECTIVE. The purpose of our study was to compare outcomes for inoperable HCC between TACE with percutaneous thermal ablation (TACE-TA) and TACE with stereotactic body radiotherapy (TACE-SBRT) using propensity score-weighted cohorts. METHODS. This retrospective study included 190 patients with a single inoperable HCC treated from 2007 to 2018 by either TACE-SBRT (n = 90) or TACE-TA (n = 100). The primary outcome was overall survival (OS). Secondary outcomes included progression-free survival (PFS) and hepatotoxicity (defined as Child-Pugh score elevation of ≥ 2 within 2-6 months after treatment). Fine-Gray competing risk models with propensity score weighting and transplant as the competing risk factor were used to model OS and PFS. RESULTS. The median follow-up time was 48.2 months. Both OS and PFS were significantly higher for TACE-TA (77% and 76%, respectively, at 2 years) than TACE-SBRT (49% and 50%, respectively, at 2 years) in the propensity score-weighted multivariate model (OS: subdistribution hazard ratio [sHR] = 2.70, p < .001; PFS: sHR = 1.71, p = .02). Treatment-related hepatotoxicity occurred in 9% of patients who underwent TACE-TA versus 27% of those who underwent TACE-SBRT (p = .01). For the subset of patients with Barcelona Clinic Liver Cancer A HCC and Child-Pugh A cirrhosis (TACE-SBRT, n = 36 patients; TACE-TA, n = 55 patients), OS (p = .11) and PFS (p = .19) were not significantly different between the two treatment modalities. CONCLUSION. Compared with TACE-SBRT, TACE-TA showed superior OS and PFS, possibly from its lesser hepatotoxicity. The two strategies did not differ in OS and PFS for patients with the earliest-stage HCC and preserved liver function. CLINICAL IMPACT. Across all patients, TACE-TA may be superior to TACE-SBRT for inoperable HCC.
Combined stereotactic body radiotherapy and trans-arterial chemoembolization as initial treatment in BCLC stage B-C hepatocellular carcinoma. [2020]We retrospectively evaluated the efficacy and safety of stereotactic body radiotherapy (SBRT) combined with trans-arterial chemoembolization (TACE) as initial therapy in Barcelona Clinic Liver Cancer (BCLC) system stage B-C hepatocellular carcinoma (HCC).
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]The superiority of stereotactic body radiotherapy (SBRT) combined with transcatheter arterial chemoembolization (TACE) compared to SBRT alone as the first-line therapy for unresectable hepatocellular carcinoma (HCC) remains unclear. We conducted this meta-analysis to compare the efficiency and safety of SBRT combined with TACE (ST group) and SBRT alone (SA group).
Stereotactic body radiotherapy plus transcatheter arterial chemoembolization for inoperable hepatocellular carcinoma patients with portal vein tumour thrombus: A meta-analysis. [2022]The efficacy and safety of stereotactic body radiotherapy (SBRT) plus transcatheter arterial chemoembolization (TACE) versus SBRT or TACE alone(monotherapy) for hepatocellular carcinoma (HCC) patients with portal vein tumour thrombus (PVTT) remains controversial. This meta-analysis was performed to provide more powerful evidence for clinical strategies in inoperable HCC with PVTT.
Pilot study of stereotactic body radiation therapy combined with transcatheter arterial chemoembolization for small hepatocellular carcinoma. [2022]We retrospectively evaluated the local tumor control and safety of transcatheter arterial chemoembolization (TACE) followed by stereotactic body radiation therapy (SBRT) for small hepatocellular carcinoma (HCC) in this pilot study.
Stereotactic body radiation therapy combined with transcatheter arterial chemoembolization for small hepatocellular carcinoma. [2022]To compare the tumor control and safety of stereotactic body radiation therapy (SBRT) combined with transcatheter arterial chemoembolization (TACE) for small, solitary, and hypervascular hepatocellular carcinoma (HCC) with TACE alone.
Biliary complications of arterial chemoembolization of hepatocellular carcinoma. [2015]Transarterial chemoembolization (TACE) is the most frequently used palliative therapy for unresectable hepatocellular carcinoma (HCC). It is a safe and effective procedure with few major and minor complications. Rarely, biliary complications are also encountered following TACE. The goal of our study was to investigate the incidence and the presentation of biliary complications following TACE in patients with HCC.
Stereotactic body radiation therapy following transarterial chemoembolization for unresectable hepatocellular carcinoma. [2022]Transarterial chemoembolization (TACE) is the standard for unresectable Barcelona Clinic Liver Cancer (BCLC) B hepatocellular carcinoma (HCC) patients but is not an ablative therapy. This study explores stereotactic body radiation therapy (SBRT) as an adjuvant or salvage to drug eluting bead (DEB)-TACE.