UMIN-CTR Clinical Trial

Public title

Comparison between stereotactic body radiotherapy and transcatheter arterial chemoembolization for hepatocellular carcinoma: Meta-analysis and systematic review.

Acronym

Comparison between stereotactic body radiotherapy and transcatheter arterial chemoembolization for hepatocellular carcinoma: Meta-analysis and systematic review.

Scientific Title

Comparison between stereotactic body radiotherapy and transcatheter arterial chemoembolization for hepatocellular carcinoma: Meta-analysis and systematic review.

Scientific Title:Acronym

Comparison between stereotactic body radiotherapy and transcatheter arterial chemoembolization for hepatocellular carcinoma: Meta-analysis and systematic review.

Region

Japan

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

In the Barcelona Clinic Liver Cancer staging and treatment strategy (BCLC) guideline, surgery, radiofrequency ablation (RFA), and trans-arterial chemoembolization (TACE) are considered as standard treatment for hepatocellular carcinoma (HCC). Although stereotactic body radiotherapy (SBRT) has been recognized as novel local therapy for HCC, SBRT is still not mentioned in BCLC guideline due to lack of randomized control trials. Recently, the randomized controlled trial which compared SBRT and TACE for HCC has published. However, the number of cases enrolled was too small to demonstrate the therapeutic efficacy of SBRT. In recent years, there are several retrospective studies which compared SBRT and TACE using propensity score matching (PSM). Aim of current meta-analysis is to summarize data from quality studies compared SBRT and TACE.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Hazard ratio of overall survival and local control

Key secondary outcomes

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

We will include observational studies using propensity score analysis and randomized controlled studies that compared SBRT and TACE for HCC. Articles were published as full reports, brief reports, or conference abstracts, regardless of their primary end point. Non-English reports were excluded.

Key exclusion criteria

N/A

Target sample size

Name of lead principal investigator

1st name	Satoshi
Middle name
Last name	Komiyama

Organization

Yokohama City University Medical Center

Division name

Chemotherapy division/Gastroenterological Center

Zip code

2320024

Address

4-57 Urafune-cho, Minami-ku, Yokohama, Kanagawa

TEL

0452615656

Email

skomiyam@yokohama-cu.ac.jp

Name of contact person

1st name	Satoshi
Middle name
Last name	Komiyama

Organization

Yokohama City University Medical Center

Division name

Chemotherapy division/Gastroenterological Center

Zip code

2320024

Address

4-57 Urafune-cho, Minami-ku, Yokohama, Kanagawa

TEL

0452615656

Homepage URL

Email

skomiyam@yokohama-cu.ac.jp

Institute

Yokohama City University Medical Center

Institute

Department

Personal name

Organization

NA

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

NA

Address

NA

Tel

NA

Email

NA

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

07

Month

26

Day

URL releasing protocol

https://www.sciencedirect.com/science/article/pii/S0167814024042762?via%3Dihub

Publication of results

Partially published

URL related to results and publications

https://www.sciencedirect.com/science/article/pii/S0167814024042762?via%3Dihub

Number of participants that the trial has enrolled

0

Results

SBRT led to a comparable OS to TACE, and significantly improved LC. Considerable heterogeneity was observed in the HR of OS and LC. Although there was no significant difference in the rate of grade 3 or higher toxicities between TACE and SBRT, or between studies, liver toxicity was identified as a common adverse event associated with both SBRT and TACE. Compared to TACE, SBRT showed a comparable OS and improved LC without serious toxicity.

Results date posted

2025

Year

01

Month

24

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Patients with HCC treated with SBRT or TACE were included in this study. Studies involving patients with metastatic liver tumors or intrahepatic cholangiocarcinomas were excluded.

Participant flow

We systematically searched the PubMed, Cochrane, EMBASE, and WebofScience databases to identify randomized controlled trials and studies comparing SBRT and TACE using PS analysis. The hazard ratios (HRs) for OS and LC were pooled.

Adverse events

Treatment-related complications were observed in five studies. The rates of grade 3 or higher toxicity, including liver toxicity, were not significantly different between TACE and SBRT, and there were large differences among institutions. Treatment-related deaths were observed in patients treated with both TACE and SBRT, with no significant differences.

Outcome measures

The adjusted HR for OS, as the primary endpoint, was assessed based on a randomized controlled trial and four observational studies involving 634 patients. A random model meta-analysis of these studies comprised 301 patients who underwent SBRT, and 333 patients who underwent TACE; the random-model meta-analyses of these studies revealed that SBRT led to an equivalent OS rate compared with TACE. We assessed the HRs for LC in one randomized controlled trial and three retrospective studies that reported LC in 529 patients. Although the LC after SBRT was comparable to that after TACE, the HRforLCinthestudybyBettinger etal. could not be calculated because there was no sequential assessment of LC. A random-model meta-analysis of these studies, except for the study by Bettinger et al., revealed that the time to LC of patients who were treated with SBRT was longer than that of those treated with TACE.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2023

Year

07

Month

26

Day

Date of IRB

2023

Year

07

Month

26

Day

Anticipated trial start date

2023

Year

07

Month

26

Day

Last follow-up date

2023

Year

07

Month

26

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study Search
We will systematically search PubMed, the Cochrane database, EMBASE, and Web of Science as of August 1, 2023.

Reference lists in the included articles and review articles will be also hand searched.

Data synthesis
HR from propensity score matched studies will be pooled. Prior to generic inverse variance meta-analysis using RevMan 5.0 (Cochrane Collaboration, London, UK), HR will be log converted.
Subgroup analyses which focus on liver function will be performed.
Statistical significance will be judged by P 0.05.

Registered date

2023

Year

07

Month

26

Day

Last modified on

2025

Year

01

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058977