UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008732 |
|---|---|
| Receipt number | R000010259 |
| Scientific Title | Therapeutic efficacy of transcatheter arterial infusion chemotherapy plus transcatheter arterial chemoembolization with a fine-powder formulation of cisplatin for hepatocellular carcinoma. |
| Date of disclosure of the study information | 2012/08/20 |
| Last modified on | 2012/08/20 17:54:53 |
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Basic information
Public title
Therapeutic efficacy of transcatheter arterial infusion chemotherapy plus transcatheter arterial chemoembolization with a fine-powder formulation of cisplatin for hepatocellular carcinoma.
Acronym
Therapeutic efficacy of TAI plus TACE with DDPH for hepatocellular carcinoma.
Scientific Title
Therapeutic efficacy of transcatheter arterial infusion chemotherapy plus transcatheter arterial chemoembolization with a fine-powder formulation of cisplatin for hepatocellular carcinoma.
Scientific Title:Acronym
Therapeutic efficacy of TAI plus TACE with DDPH for hepatocellular carcinoma.
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, the efficacy of transcatheter arterial infusion chemotherapy plus transcatheter arterial chemoembolization (TACE) using a suspension of a fine-powder formulation of cisplatin (DDPH) in lipiodol (LPD) in the treatment of hepatocellular carcinoma (HCC) was evaluated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary efficacy endpoint of the current study was the objective response rate.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Preparation
1) DDPH for TAI
50 mg of DDPH powder are dissolved in 70 ml of saline, and the resulting solution is administered intra-arterially about 30 min using a mechanical infusion pump.
2) DDPH for TACE
DDPH was mixed with LPD (iodized oil, Lipiodol Ultra-Fluide; Andre Guerget, Aulnay-sous-Bois, France). The DDPH-LPD suspension was prepared by mixing 50 mg of DDPH into 10 mL of LPD. The dosage of DDPH-LPD suspension was adjusted depending on the tumor size, number of tumors, degree of liver impairment, and renal function, but the maximum dose of DDPH-LPD suspension was not allowed to exceed 10 mL.
Treatment procedures
Before TACE procedures, hepatic angiography was performed by the femoral approach using a 4-Fr catheter and a 1.8-Fr to 2.4-Fr microcatheter. After that, microcatheter advanced through the first catheter into the proper hepatic artery, where it was used to intra-arterially infuse the DDPH powder solution. In all TACE procedures, hepatic angiography was performed by the femoral approach using a 4-Fr catheter and a 1.8-Fr to 2.4-Fr microcatheter. After confirming the hepatic arteries supplying the target tumor, a catheter was selectively inserted into the hepatic artery supplying the target tumor, and the DDPH-LPD suspension was injected. In patients with several tumors in the liver, superselective catheterization was performed for each lesion. If superselective catheterization was not possible, the DDPH-LPD suspension was injected into the right and left main hepatic arteries distal to the origin of the cystic artery. After the injection, arterioembolization was performed used porous gelatin particles (Gelpart; Nippon Kayaku, Tokyo, Japan) mixed with contrast medium.
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
Eligibility criteria were as follows: (1) Eastern Cooperative Oncology Group (ECOG) performance status of 0–2; (2) age over 20 years; (3) diagnosis of HCC based on imaging or histological findings; (4) no indication for surgical resection or local ablation therapy such as radiofrequency ablation (RFA) (5) bidimensionally measurable hepatic lesions; (6) adequate hepatic function (serum total bilirubin <3.0 mg/dl), and adequate renal function (serum creatinine <the upper normal limit); (7) no HCC treatment for 4 weeks before study entry.
Key exclusion criteria
Pregnancy women
Patients who had allergy of cisplatin
Patients who had severe disease except HCC.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kasai |
Organization
Iwate Medical University
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
Uchimaru 19-1, Morioka, Iwate 020-8505, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Iwate Medical University
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 20 | Day |
Last modified on
| 2012 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010259
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