UMIN-CTR Clinical Trial

Basic information
Public title	Safety assessment of repeated alternate infusion of cisplatin and gelatin fragments for balloon-occluded trans-catheter arterial chemo-embolization for treatment of hepatocellular carcinomas.
Acronym	Assessment of RAIB-TACE for treatment of HCCs.
Scientific Title	Safety assessment of repeated alternate infusion of cisplatin and gelatin fragments for balloon-occluded trans-catheter arterial chemo-embolization for treatment of hepatocellular carcinomas.
Scientific Title:Acronym	Assessment of RAIB-TACE for treatment of HCCs.
Region	Japan

Condition
Condition	Hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is afety assessment of repeated alternate infusion of cisplatin and gelatin fragments for balloon-occluded trans-catheter arterial chemo-embolization for treatment of hepatocellular carcinomas.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Safety of RAIB-TACE
Key secondary outcomes	Tumor response based on RECICL criteria

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	repeated alternate infusion of cisplatin and gelatin fragments for balloon-occluded trans-catheter arterial chemo-embolization for hepatocellular carcinomas.
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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Diagnosis of hepatocellular carcinoma according to EASL guideline 2)Indication of TACE 3)over 20 year old and less 90 year old 4)ECOG Performance Status of 0 to 1 5)Informed consent is obtained. 6)promising over 3 month alive after treatment
Key exclusion criteria	1)After rupture of HCC with shock vital 2)History of surgical or endoscopic biliary tract reconstruction 3)Dilation of segmental biliary tract 4)Lymph node metastases displacing biliary tract or portal vein 5)Prominent arterio-portal shunt or arterio-venous shunt 6)eGFR is under 50 ml/min/1.73m2 7)Child-Pugh score: over 7 score 8)History of TACE within 3 months in the area of therapeutic plan 9)Hepatic encephalopathy or severe psychic disturbance 10)Severe drug allergy including iodine contrast medium or other drugs 11)Inadequate patients to undergo the procedure safely 12) Tumor invades main or first branch of portal vein
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Sodai Middle name Last name Hoshiai
Organization	University of Tsukuba
Division name	Faculty of Medicine
Zip code	305-8577
Address	1-1-1, Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-2111
Email	hoshiai@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Sodai Middle name Last name Hoshiai
Organization	University of Tsukuba
Division name	Faculty of Medicine
Zip code	305-8577
Address	1-1-1, Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-2111
Homepage URL
Email	hoshiai@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	University of Tsukuba
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Mito Kyodo General Hospital Tsukuba Memorial Hospital Tsukuba Medical Center Hospital Japanese Red Cross Maebashi Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	T-CREDO
Address	Amakubo 2-1-1, Tsukuba
Tel	029-853-3914
Email	t-credo.adm@un.tsukuba.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 29 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/34715322/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/34715322/
Number of participants that the trial has enrolled	44
Results	Balloon-occluded alternate infusion transarterial chemoembolization is safe and effective for achieving a high ORR while preserving liver function.
Results date posted	2022 Year 10 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Forty-three patients with HCC from 4 medical centers were enrolled in this multicenter prospective study. Of these, 41 patients were observed for 6 months following balloon-occluded alternate infusion transarterial chemoembolization. The primary endpoint was the safety of the procedure, and the secondary endpoint was the objective response rate (ORR) of the HCCs at 2 months following treatment.
Participant flow	Forty-three patients with HCC from 4 medical centers were enrolled in this multicenter prospective study. Of these, 41 patients were observed for 6 months following balloon-occluded alternate infusion transarterial chemoembolization. The primary endpoint was the safety of the procedure, and the secondary endpoint was the objective response rate (ORR) of the HCCs at 2 months following treatment.
Adverse events	Three patients experienced adverse events, including 1 patient with facial swelling and skin rash, dissection of the celiac artery, and bland portal vein thrombus. No major adverse events were identified. Two (5.3%) patients regressed from a Child-Pugh classification of A to B. The balloon-
Outcome measures	The balloon-occluded alternate infusion transarterial chemoembolization treatment achieved a 22.0% complete response (CR) rate and a 73.2% ORR (95% confidence interval [CI], 57.9%-84.4%). In a retrospective analysis of 23 patients with HCCs above the up-to-7 criteria, the CR rate and ORR of the balloon-occluded alternate infusion transarterial chemoembolization were 21.7% and 82.6% (95% CI, 62.3%-93.6%), respectively.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 09 Month 19 Day
Date of IRB	2018 Year 11 Month 01 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 03 Day
Last modified on	2022 Year 10 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038160