WT1 peptide pulse dendritic cells vaccine therapy for pancreatic cancer following resection

JRCT ID: jRCTc031190107

Registered date:01/10/2019

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 01/04/2020
• Target sample size: 144
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): For patients with pancreatic cancer following curative resection, investigate the disease control according to immunotherapy, providing WT1 pulsed dendritic cells vaccine in addition to S-1 chemotherapy.

Outcome(s)

• Primary Outcome: Relapse free survival (RFS)

Secondary Outcome

Overall survival (OS)
Overall survival following the additive WT1 pulsed DC vaccine therapy within the S-1 chemotherapy group.
Immunological monitoring (Tetramer analysis, ELISpot assay, DTH) and relationship with OS, RFS, and incidence of adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Achieving a good understanding of the clinical trial, the patients' role as subjects of the trial, and acquiring a written consent.
2) Patients underwent S-1 as adjuvant postoperative treatment following curative resection. However, they should not have undergone other preoperative treatments.
3) Patients must have a normal oral intake.
4) Patients must be aged 20 years or older at the time of agreement acquisition.
5) Patients' PS (ECOG) must be 0 to 1.
6) When enrolling in the study, individuals should not be participating in other clinical studies.
7) No history of treatment of chemotherapy or radiotherapy in the past 3 years.
8) The cardiovascular system has a sufficient function to undergo apheresis of peripheral-blood mononuclear cells.
9) Sufficient functionality of bone marrow, liver, and the kidneys is maintained. Specifically, the patients must satisfy the following criteria within 14 days of pre-registration.
1 White blood cell count >3,000/microL, <12,000/microL
2 Hemoglobin >8.0 g/dL
3 Platelet >100,000/microL
4 Total bilirubin <2.0 mg/dL
5 AST <100 IU/L
6 ALT <100 IU/L
7 Serum creatinine <1.2 mg/dL
10) Negative lab results for HBV, HCV, HTLV-1, HIV, and syphilitic spirochete.
11) Compatibility of HLA typing for the WT1 peptide (with HLA-A 24:02 or HLA-A 02:01).

Exclude criteria

When the agreement acquisition conflicts with the following exclusion items, the patient cannot participate to this study. Exclusion criteria are as follows:
1) Patients who preoperatively received chemotherapy or radiotherapy for cancer treatment.
2) Patients who experienced, before registration, any recurrence, peritoneal dissemination, or peritoneal dissemination.
3) Patients for whom immunohistochemistry did not confirm WT 1 expression in the tumor tissue specimen.
4) Patients identified with moderate or severe pleural effusion or ascites fluid by chest X-rays and abdominal CT.
5) Patients with multiple primary cancers.
6) Patients with a history of allergy to OK-432 and penicillin G.
7) Patients with diarrhea, hypertension, and diabetes under poor control.
8) Patients with unstable angina (developing or progression within 3 weeks) or a history of myocardial infarction within 6 months.
9) Presence of a serious heart disorder (e.g., uncontrolled heart failure or arrhythmia). Patients with cerebrovascular disease. Patients with heart failure should match class III or IV in the New York Heart Association functional classification.
10) Patients with severe pulmonary fibrosis or interstitial pneumonia.
11) Patients with serious complications (e.g., heart failure, renal failure, hepatic failure, peptic ulcer, and intestinal paralysis).
12) Patients taking an immunosuppressive drug or an adrenal cortical hormone (more than 10mg/day with conversion of prednisolone).
13) Patients with a serious drug allergy.
14) Patients suspected of having or diagnosed with myelodysplastic syndrome (MDS).
15) Patients with an active infection (except the viral hepatitis) causing a fever of 38 degrees Celsius or higher.
16) Patients requiring transfusion within two weeks pre-registration.
17) Patients undergoing fluoropyrimidine antineoplastic and antifungal agents, phenytoin or flufarin potassium treatments.
18) Patients planning on or currently receiving immune checkpoint inhibitor.
19) Pregnancy or lactation, or women inappropriately performing contraception, or who wish to preserve fertility, or wish to raise a baby.
20) Patients diagnosed with psychosis or psychiatric symptoms, and are judged to have difficulty in participating in the study.
21) Patients diagnosed with an autoimmune disease.
22) Patients who considered a medical attendant inappropriate for any reason .

Related Information

• Primary Sponsor: Yanagisawa Ryu