UMIN-CTR Clinical Trial

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
Institute	Wakayama Medical University
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031102