UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003541 |
|---|---|
| Receipt number | R000004298 |
| Scientific Title | A phase 1 study of combination chemotherapy for hepatocellular carcinoma using Miripla® (SM11355) and IA-call® (DDP-H) |
| Date of disclosure of the study information | 2010/05/01 |
| Last modified on | 2010/11/11 00:03:04 |
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Basic information
Public title
A phase 1 study of combination chemotherapy for hepatocellular carcinoma
using Miripla® (SM11355) and IA-call® (DDP-H)
Acronym
A combination chemotherapy of SM11355 and DDP-H for HCC (Phase 1)
Scientific Title
A phase 1 study of combination chemotherapy for hepatocellular carcinoma
using Miripla® (SM11355) and IA-call® (DDP-H)
Scientific Title:Acronym
A combination chemotherapy of SM11355 and DDP-H for HCC (Phase 1)
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Selection of candidate predictors for therapeutic efficacy and determination of dose-limiting toxicity, maximum tolerated dose, therapeutic dose, and a type and frequency of adverse events in chemolipiodolization uisng SM11355 coupled with intrahepatic arterial infusion of DDP-H for patients with hepatocellular carcinoma.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
1) CBC, Coagulation factors
2) Basic biochemistry (TP, Alb, AST, ALT, ALP, LDH, GTP, T.Bil, D.Bil, BUN, Crt, Na, K, Cl, CRP)
3) Specific biochemistry (ChE, T.Chol, TG, HbA1c, NAG, beta-2-microgloblin)
4) Urinalysis
5) Retention time of ICG, Ccr
Key secondary outcomes
1) Tumor marker (AFP, Fucosylated fraction of AFP, DCP)
2) Imaging evaluation of hepatocellular carcinoma
3) Serum concentratio of platinum
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
DDP-H is infused to the entire liver through a hepatic artery at a rate of 3mg/min in total of 35 mg/body surface area.
After intrahepatic arterial infusion of DDP-H, chemolipiodolization using SM11355 was performed for target HCCs according to the instruction of the drug.
If no dose-limiting toxicity (DLT) is reached at a dose level, the same regimen is carried out by increasing DDP-H 15mg/body surface area upto 15 mg/body surface area. If only one of three patients at a particular dose level is noted to have a DLT, then up to three more patients can be entered onto that dose level. If two or more patients of three or six patients are noted to have DLTs, then one has exceeded the MTD of the drug. Then additional patients are entered on the preceding dose level to ensure that one has a correct MTD—the dose to be taken into Phase II trials with the new agent. If two or more cases have already suffered from DLTs with the initial dose of DDP-H, the dose is reduced by 10 mg/body surface area down to 15 mg/body surface area.
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically and/or clinically proven hepatocellular carcinoma except for mixed type.
2) Adequate for neither surgical resection nor puncture-based therapies.
3) There are bidimensionally measurable targets in the liver.
4) Age between 20 and 79 years old.
5) ECOG performance status score of 0-2.
6) Sufficient functional reserve of major organs.
Neutrophil count : 1,500 /mm3 =<
Platelet count : 50,000 /mm3 =<
Hemoglobin : 8.0 g/dL =<
Albumin : 3.0 g/dL =<
Total bilirubin : 3.0 mg/dL =>
Total amylase in serum : 324 IU/bL =>
Creatinine clearance : 50ml/min =< (adjusted for 1.73m2 of body surface area)
7) Child-Pugh score of equal or less than 7.
8) An internal of 4 or more weeks after latest therapy against hepatocellular carcinoma.
9) A written informed consent from a patient him/her self.
Key exclusion criteria
1) Pleural effusion and/or ascites refractory to treatments.
2) Comorbidity:
Active infectious diseases except for hepatitis.
Active bleeding from GI tract.
Active concomitant cancer with invasive nature.
Severe mental disorder or hepatic encephalopathy.
3) A history of severe allergic reaction against iodine contrast medium and/or platinum agents.
4) A pregnant or lactating female or female of childbearing age unless using effective contraception.
5) Ongoing interferon therapy.
6) Difficulties of oral intake.
7) Other serious conditions judged to be inadequate by a responsible doctor.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Suda |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Gastroenterology & Hepatology
Zip code
Address
1-754 Asahi-machi, Chuo-ku, Niigata, Niigata 951-8122, Japan
TEL
025(223)6161
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Igarashi |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Gastroenterology & Hepatology
Zip code
Address
TEL
025(227)2207
Homepage URL
Sponsor or person
Institute
Niigata Hepatocellular Carcinoma Therapy Study Group
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2010 | Year | 05 | 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
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 26 | Day |
Last modified on
| 2010 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004298
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