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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024661
Receipt No. R000024660
Scientific Title Randomised phase II study of Intra-arterial infusion therapy with cisplatin suspension in lipiodol and 5-fluorouracil(New FP therapy)versus sorafenib in advanced hepatocellular carcinoma.
Date of disclosure of the study information 2016/11/01
Last modified on 2018/11/16

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Basic information
Public title Randomised phase II study of Intra-arterial infusion therapy with cisplatin suspension in lipiodol and 5-fluorouracil(New FP therapy)versus sorafenib in advanced hepatocellular carcinoma.
Acronym Randomised Phase II study of New FP therapy versus sorafenib in advanced HCC
Scientific Title Randomised phase II study of Intra-arterial infusion therapy with cisplatin suspension in lipiodol and 5-fluorouracil(New FP therapy)versus sorafenib in advanced hepatocellular carcinoma.
Scientific Title:Acronym Randomised Phase II study of New FP therapy versus sorafenib in advanced HCC
Region
Japan

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

Objectives
Narrative objectives1 evaluate and compare the efficacy and safety of sorafenib versus hepatic arterial infusion therapy using cisplatin suspension in lipiodol and 5-fluorouracil( New FP)in advanced hepatocellular carcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Overall survival, Responsive rate,AE, Down staging rate for Curative treatment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Arm A: Soragenib
800mg/day everyday

Patients will continue to receive study treatment of Arm A and B until another criterion for discontinuation or completion is met.
Interventions/Control_2 Arm B: New FP treatment
Day 1: CDDP 50mg/day, 5-FU 250mg
Day1-5: 5-FU (continuous medication) Maximum 1250mg

Patients will continue to receive study treatment of Arm A and B until another criterion for discontinuation or completion is met.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically or Clinically diagnosed as hepatocellular carcinoma (HCC) by imaging assessment and tumor maker.
2) Unsuitable for local therapy. (Including surgery, radiofrequency ablation, hepatic arterial embolization and percutaneous ethanol injection etc.)
3) Presence of intrahepatic major lesion.
4) Measurable lesion on clinical image studies by CT with contrast or MRI with contrast.
5) No lingering effects of previous therapy. (treatment-free interval: Hepatectomy and local therapy, 2 weeks or more. Hepatic arterial embolization, continuous hepatic arterial infusion and radiotherapy, 4 weeks or more.)
6) Child-Pugh classification A.
7) Performance status of 0 to 1.
8) Preservation of major organ function. (Examination should be performed within 2 weeks prior to the registration.)
9) Age more than 20 years.
10) Willing and able to comply with study procedures.
11) Provision of written informed consent.
Key exclusion criteria Patients will be excluded from the study if they meet any of the following criteria.
1) Having a history of molecular targeted drug or sorafenib.
2) Having a history of any previous systemic therapy.
3) Having clinically meaningful ascites that require a puncture method.
4) History of liver transplant.
5) Having esophageal varices that represent a high bleeding risk.
6) With cardiac infarction, unstable angina, cardiac failure and cerebral vascular disorder within 12 month before registration.
7) History of or current hepatic encephalopathy.
8) With cerebral tumors.
9) Having a dialysis.
10) With a gastrointestinal hemorrhage within 1 month before registration.
11) With a duplicate active cancer.
12) Taking drugs with CYP3A4 (Including rifampicin etc.)
13) Severe arrhythmia of CTCAE v4.0 >= grade 2 and uncontrolled high blood pressure defined in blood pressure guidelines 2014.
14) Having hypersensitivity reaction to any of the treatment components.
15) Taking approved crude drugs for cancer treatment. (Including shosaikoto.)
16) Known human immunodeficiency virus infection (HIV) or acquire immunodeficiency syndrome (AIDS) -related illness.
17) Pregnancy, nursing women.
18) Not eligible because of safety issues judged by investigators.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Rie Sugimoto
Organization National Hospital Organization Kyushu Cancer Center
Division name Department of Hepato-biliary-pancreatology
Zip code
Address 3-1-1 Notame Minamiku Fukuoka, Japan 811-1395
TEL 092-541-3231
Email sugimoto.r@nk-cc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Kato
Organization Kyushu University
Division name Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences
Zip code
Address 3-1-1 Maidashi Higashiku Fukuoka
TEL 092-642-5282
Homepage URL
Email mkato11@med.kyushu-u.ac.jp

Sponsor
Institute National Hospital Organization Kyushu Cancer Center
Department of Hepato-biliary-pancreatology
Institute
Department

Funding Source
Organization No
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
Email

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
2016 Year 11 Month 01 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 Terminated
Date of protocol fixation
2015 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2018 Year 05 Month 01 Day
Date of closure to data entry
2018 Year 05 Month 01 Day
Date trial data considered complete
2018 Year 05 Month 01 Day
Date analysis concluded
2018 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 31 Day
Last modified on
2018 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024660

Research Plan
Registered date File name
2017/05/15 動注VSネクサバール試験実施計画書_DC修正_最終(新)2.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2017/05/11 動注VSネクサバール試験実施計画書_DC修正_最終(新)2.docx


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