UMIN-CTR Clinical Trial

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

advanced biliary tract cancer refractory to priortherapy

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kyushu University Hospital

Institute

Department

Personal name

Organization

Health Labour Sciences Research Grant

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

九州大学病院

Date of disclosure of the study information

2014

Year

01

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

01

Month

07

Day

Last modified on

2014

Year

05

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014833