UMIN-CTR Clinical Trial

Public title

Phase I/II clinical trila by gemcitabine+CDDP- or S-1- combined peptide vaccination for metastatic biliary tract cancers

Acronym

Clinical trila by chemotherapy-combined peptide vaccination for metastatic biliary tract cancers

Scientific Title

Phase I/II clinical trila by gemcitabine+CDDP- or S-1- combined peptide vaccination for metastatic biliary tract cancers

Scientific Title:Acronym

Clinical trila by chemotherapy-combined peptide vaccination for metastatic biliary tract cancers

Region

Japan

Condition

metastatic biliary tract cancers

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

Two-step phase I/II clinical trial: recommended doses will be determined by phase I, and over-all survival, DCR, RR, PFS, and AE will be examined by phase II. Primary endpoint is OS, compared with the result obtained by ABC-02 trial.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Overall survival

Key secondary outcomes

DCR, RR, PFS, AE, immunological reactions (CTL, CD8, regT)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine	Vaccine	Gene

Interventions/Control_1

emcitabine+CDDP/vaccination (first line), S-1/vaccination (second line).
genetic type of HLA-A is blinded and will be key-open at the end of trial.

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. Pathologically diagnosed biliary tract cancers -bile duct cancer, gall bladder cancer or ampulla cancer of duodenum.

2. Primary tumor is not curatively resectable or metastatic lesion is not curatively resectable.

3. Patient, obtains measurable lesions.

4. Patient, has no previous treatments other than surgery. Previous treatments include artery-infusional chemotherapy and postoperative adjuvant chemotherapy.

5. older than 19 years.

6. PS=0, 1 or 2 (ECOG).

7. Oral intake is possible.

8. Major organ functions, such as bone marrow, heart, liver, kidney, are obtained, as follows (data within 14 days before trial registration)
WBC>=3500/microL and <=10000/microL
platelets>=100000/microL
lymphocytes>=1000/microL
GOT(AST)<=100IU/L
GPT(ALT)<=100IU/L
T-Bilirubin<=2.0mg/dL (<=3.0mg/dL cases with biliary drainage)
creatinine<=1.2mg/dL
CCR>=50mi/min (Cockcroft-Gault)

9. Patients expected to live more than three months

10. Documented informed consent

Key exclusion criteria

Patients
-obtains previous radiation therapy for biliary tract cancers.
-obtains brain metastasis not manipulated.
-obtains active duplicated neoplastic diseases.
-obtains co-morbidity as follows; intestinal paralysis, intestinal obstruction, diabetes mellitus, hypertension, angina pectoris, livet cirrhosis, pneumonitis, emphysema.
-is HIV-positiveness
-has past history of severe allergic reaction for gemcitabine, cisplatin, or TS-1.
-obtains ascites or pleural effusion that needs treatment.
-has severe diarrhea or GI bleeding.
-has treatment by frucitosine
-is pregnat or can be pregnant.
-desires partners pregnancy.
-has HLA-A genotype opened.

Target sample size

22

Name of lead principal investigator

1st name
Middle name
Last name	Takahiro Mori, MD PhD

Organization

Tohoku University Graduate School of Medicine

Division name

Tohoku University Cancer Center

Zip code

Address

1-1 Seiryo-cho, Aobaku, Sendai

TEL

022-717-7087

Email

Name of contact person

1st name
Middle name
Last name	Takahiro Mori, MD PhD

Organization

Tohoku University Graduate School of Medicine

Division name

Tohoku University Cancer Center

Zip code

Address

TEL

Homepage URL

Email

tamori@med.tohoku.ac.jp

Institute

Tohoku University Hospital

Institute

Department

Personal name

Organization

Tohoku University Hospital

Organization

Division

Category of Funding Organization

Self funding

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

Date of disclosure of the study information

2010

Year

11

Month

03

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

Terminated

Date of protocol fixation

2010

Year

09

Month

28

Day

Date of IRB

Anticipated trial start date

2010

Year

11

Month

01

Day

Last follow-up date

2011

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

11

Month

01

Day

Last modified on

2011

Year

12

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005371