UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024661 |
|---|---|
| Receipt number | 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 09:37:12 |
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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
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
mkato11@med.kyushu-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Kyushu Cancer Center
Department of Hepato-biliary-pancreatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024660
