UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034371 |
|---|---|
| Receipt number | R000038160 |
| 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. |
| Date of disclosure of the study information | 2018/10/29 |
| Last modified on | 2022/10/05 13:37:51 |
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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
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
hoshiai@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038160
