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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012778
Receipt No. R000014833
Scientific Title OCV-C01 as a combination therapy of peptide-based cancer vaccines for patients with advanced biliary tract cancer refractory to priortherapy : Phase II study
Date of disclosure of the study information 2014/01/09
Last modified on 2014/05/02

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Basic information
Public title OCV-C01 as a combination therapy of peptide-based cancer vaccines for patients with advanced biliary tract cancer refractory to priortherapy : Phase II study
Acronym OCV-C01 therapy for patients with advanced biliary tract cancer
Scientific Title OCV-C01 as a combination therapy of peptide-based cancer vaccines for patients with advanced biliary tract cancer refractory to priortherapy : Phase II study
Scientific Title:Acronym OCV-C01 therapy for patients with advanced biliary tract cancer
Region
Japan

Condition
Condition advanced biliary tract cancer refractory to priortherapy
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and the safety of OCV-C01 for patients with advanced biliary tract cancer refractory to priortherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall Survival (OS)
Key secondary outcomes 1) Progression free survival (PFS)
2) Response rate
3) Disease control rate
4) Adverse events
5) Serious adverse events
6) Biomakers (specific CTL respnse, etc)

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 OCV-C01 by 1.0 mL/body will be administrated subcutaneously once per week to an axillary region or the inguinal region by making medication into one course for four weeks.
When an axillary region or the inguinal region cannot be medicated, subcutaneous administration to the upper arm, a thigh, or an abdomen will be caerried out.
The above-mentioned course is repeated until it corresponds to "The medication stop standard established" separately. The last medication day is set up from a medication opening day to the 365th by the longest.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Diagnosed as a biliary tract cancer (carcinoma of the intrahepatic bile duct (IHBD), the extrahepatic bile duct (EHBD), the gallbladder (GB), or the ampulla of Vater (AV).
2) Histologically proven adenocarcinoma or adenosquamous carcinoma for patients with EHBD, GB, or AV carcinomas, or adenocarcinoma for IHBD carcinomas.
Presence of measurable disease is not considered.
3) Unresectable biliary tract cancer designated as stage II - IV.
4) Refractory or not tolerated to the regimens containing gemcitabine.
5) Extension of a survival period is not expectable with radiotherapy.
6) Performance Status (ECOG) is 0 or 1.
7) The age at the time of consent acquisition is aged 20 and over.
8) Main internal-organs functions are held and following condition are met.
(1) white blood count >=2,000 /cmm
(2) neutrophils >=1,000 >/cmm
(3) hemoglobin >=8.0 g/dL
(4) platelets 5.0x104 /cmm
(5) AST<=200 IU/L
(6) ALT<=200 IU/L
(7) serum creatinine <=1.5 mg/dL
(8) Investigators judgment, there is no event it becomes difficult to administrate a medicine for the patient.
9) Written informed concent for this clinical trial is obtained by the patient.
Key exclusion criteria 1) The patient have history of cancer immunotherapy.
2) Double cancer for less than one year, except cancer in situ or intramucosal cancer.
3) The primary disease has permeated and bleeding is strongly suspected.
4) Interstitial pneumonia or pulmonary fibrosis or past history.
5) Ascites fluid or pleural effusion with difficult control.
6) Pericardial effusion in need of puncture and discharge.
7) Serious infection or being suspected.
8) Brain metastasis or being suspected by clinical symptoms.
9) Serious mental disorder or serious neuropathy.
10) Cardiac disease, lung disease, renal disease, or liver disease that is difficult to control.
11) Grade 4 (CTCAE v4.0) or co-existing disease with poor control.
12) History of myocardial infarction, severe unstable angina pectoris, CABG, congestive heart failure, cerebrovascular accident, pulmonary embolism, deep-vein thrombosis, or other severe thromboembolism within 12 months before administration of OCV-C01.
13) Unhealed traumatic lesion, including traumatic fracture.
14) Evidence of bleeding diathesis or severe coagulopathy, or past histories.
15) Need continuous medication of antiplatelet drug except aspirin.
16) High blood pressure with poor control in spite of getting suitable medical treatment.
17) Heart failure that requires medical treatment.
18) Patients who require systemic administration of the following agents during the study treatment period.
(1) Corticosteroid
(2) Immunosuppresant, Immunostimulant
(3) G-CSF, M-CSF
(4) Erythropoietin
20) The result of HLA-A*24:02 has become clear beforehand.
21) Pregnant females, or nursing mothers who cannot stop lactation. Patient or patients partner unwilling to use adequate contraception during the study period and until 180 days after the last administration day for male, or until 120 days after the last administration day for female.
22) As determined by the principal investigator or the sub-investigator the subject are not adequate to participate in the trial.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenzaburo Tani
Organization Kyushu University Hospital
Division name Department of Advanced Molecular and Cell Therapy
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka, Fukuoka 812-8582, Japan
TEL (+81)92-642-5996
Email taniken@bioreg.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihisa Tsuruta
Organization Kyushu University Hospital
Division name Department of Advanced Molecular and Cell Therapy
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka, Fukuoka 812-8582, Japan
TEL 092-642-5996
Homepage URL
Email ttsuruta@sentan.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

Funding Source
Organization Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
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 九州大学病院

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 09 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 Open public recruiting
Date of protocol fixation
2013 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2014 Year 05 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
2014 Year 01 Month 07 Day
Last modified on
2014 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014833

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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