UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027179
Receipt number R000031102
Scientific Title A double-blind, randomized clinical trial comparing S-1 in combination with DC vaccine loaded with WT1 peptides (TLP0-001) or placebo for the patients with advanced pancreatic cancer refractory to standard chemotherapy.
Date of disclosure of the study information 2017/05/01
Last modified on 2022/11/01 11:41:50

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Basic information

Public title

A double-blind, randomized clinical trial comparing S-1 in combination with DC vaccine loaded with WT1 peptides (TLP0-001) or placebo for the patients with advanced pancreatic cancer refractory to standard chemotherapy.

Acronym

A double-blind, randomized clinical trial comparing S-1 in combination with DC vaccine loaded with WT1 peptides (TLP0-001) or placebo for the patients with advanced pancreatic cancer refractory to standard chemotherapy.

Scientific Title

A double-blind, randomized clinical trial comparing S-1 in combination with DC vaccine loaded with WT1 peptides (TLP0-001) or placebo for the patients with advanced pancreatic cancer refractory to standard chemotherapy.

Scientific Title:Acronym

A double-blind, randomized clinical trial comparing S-1 in combination with DC vaccine loaded with WT1 peptides (TLP0-001) or placebo for the patients with advanced pancreatic cancer refractory to standard chemotherapy.

Region

Japan


Condition

Condition

pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of TLP0-001 in combination with S-1.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

Overall survival

Key secondary outcomes

Progression free survival
Response rate
Adverse events
Rate of dose limiting toxicity (first six patients in active group)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Active group:
TLP0-001 1mL will be administered bi-weekly as 1 treatment course for every 6 weeks. Besides, S-1 80mg/m2 will be administered for 4 weeks followed by a 2-week rest. Administration will be continued until patient's condition meets withdrawal criteria.

Interventions/Control_2

Placebo group:
Placebo 1mL will be administered bi-weekly as 1 treatment course for every 6 weeks. Besides, S-1 80mg/m2 will be administered for 4 weeks followed by a 2-week rest. Administration will be continued until patient's condition meets withdrawal criteria.

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) Invasive pancreatic ductal carcinoma histologically or cytologically confirmed as adenocarcinoma or squamous cell carcinoma. Presence of measurable disease is not considered.
(2) Refractory to standard therapy.
-Patient must have treated by Gemcitabine and nab-paclitaxcel at least one time.
-It doesn't matter weather patient had treated by another antitumor drug except for pyrimidine fluoride drug or radiation therapy.
(3) Patients must be >=20 years old and <=79 years old at the time of primary consent.
(4) Karnofsky Performance Status must be >=80.
(5) Patients must have prescribed type of Human Leukocyte Antigen both class I and class II.
(6) Life Expectancy must be >=3 months.
(7) The following criteria must be satisfied in laboratory tests conducted before enrollment. And G-CSF, Erythropoetin, Blood products and transfusion must be untried within 7 days before laboratory tests.
-White blood cell count >=3,000/mm3 ,<=12,000/mm3
-Neutrophil count >=1,500/mm3
-Hemoglobin >= 9.0 g/dL
-Platelet count >=10,000mm3
-Total bilirubin <=2.0 mg/dL(to be permitted <=3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice)
-AST <=150 IU/L
-ALT <=150 IU/L
-Serum Creatinine <=1.5 mg/dL
-Creatinine clearance >=50 mL/min
(8) Oral intake is possible.
(9) The period from the end of previous treatment to the beginning of this trial must be satisfied following criteria.
-antitumor drug : >=15days
-domestic unrecognized drug which has anti-tumor effect. : >=29days, antibody drug : >=57days
-radiotherapy : >=29days
- laparotomy: >=15days
- systemic treatment of corticosteroid: >=15days
(10) Patient must have signed the consent form

Key exclusion criteria

(1) Prior treatment of pyrimidine fluoride drug.
(2) Prior treatment of Cancer immunotherapy.
(3) Active double cancer (include asynchronous double cancer with disease-free duration <=1 year) except carcinoma in situ or intramucosal cancer.
(4) Interstitial pneumonia or pulmonary fibrosis.
(5) History of severe hypersensitivity to S-1 or its component.
(6) History of hypersensitivity to OK-432, penicillin G, Gentamicin or streptomycin.
(7) History of hypersensitivity to pig-derived or mouse derived component.
(8) History of severe allergies (asthmaticus, anaphylactic shock etc).
(9) Water diarrhea.
(10) Cerebral metastasis or being suspected.
(11) Pleural effusion, ascites fluid, or pericardial fluid in need of drainage.
(12) Serious infections or being suspected.
(13) Positive for serum anti-HBs Ag or HBV-DNA.
(14) Positive for HCV Ab, HTLV1 Ab, HIV Ab, syphilis spirochete or parvovirus.
(15) Severe nervous disorder or mental disorder.
(16) Uncontrolled heart disease, pulmonary disease, kidney disease, or liver disease.
(17) Complication of CTCAE Grade 4 or another uncontrolled complication.
(18) Need continuous medication of flucytosine, phenytoin or warfarin.
(19) Patients who require systemic administration of the following agents during the study treatment period.
1.Corticosteroid
2.Immunosuppresant, Immunostimulant
3.Erythropoietin
(20) Autoimmune disease that needs treatment.
(21) Test products can not be prepared to carry out at least one course (three times) from the autologous blood obtained by the apheresis performed before the secondary consent.
(22) Current participation in other clinical trials.
(23) Pregnant females or nursing mothers who can not stop lactation after the recruitment. Patients or partners, who don't attempt to doing contraception during the study period.
(24) The subject who was determined by investigator that being not adequate to participate in the trial.

Target sample size

185


Research contact person

Name of lead principal investigator

1st name Hiroki
Middle name
Last name Yamaue

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code

641-8510

Address

811-1 Kimiidera, Wakayama, Japan

TEL

073-441-0613

Email

trial2nd@wakayama-med.ac.jp


Public contact

Name of contact person

1st name Masahiro
Middle name
Last name Katsuda

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code

641-8510

Address

811-1 Kimiidera, Wakayama, Japan

TEL

073-441-0613

Homepage URL

https://www.wakayama-med.ac.jp/med/chikenkanri/patient/file/28018_nige_sui_170929.pdf

Email

katsuda@wakayama-med.ac.jp


Sponsor or person

Institute

Wakayama Medical University

Institute

Department

Personal name



Funding Source

Organization

Tella pharma, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Wakayama Medical University Ethics Review Committee

Address

811-1 Kimiidera, Wakayama, Japan

Tel

073-441-0547

Email

chiken@wakayama-med.ac.jp


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

手稲渓仁会病院(北海道)、千葉県がんセンター(千葉県)、千葉徳洲会病院(千葉県)、横浜市立大学病院(神奈川県)、神奈川県立がんセンター(神奈川県)、愛知県がんセンター(愛知県)、名古屋大学病院(愛知県)、富山大学病院(富山県)、大阪市立大学病院(大阪府)、奈良県立医科大学病院(奈良県)、和歌山県立医科大学病院(和歌山県)、山口大学病院(山口県)、九州がんセンター(福岡県)、長崎大学病院(長崎県)、弘前大学病院(青森)、関西医科大学病院(大阪)


Other administrative information

Date of disclosure of the study information

2017 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

No longer recruiting

Date of protocol fixation

2017 Year 03 Month 01 Day

Date of IRB

2016 Year 12 Month 27 Day

Anticipated trial start date

2017 Year 03 Month 14 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry

2024 Year 06 Month 30 Day

Date trial data considered complete

2024 Year 09 Month 30 Day

Date analysis concluded

2025 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 04 Month 28 Day

Last modified on

2022 Year 11 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031102


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name