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A single-center clinical study to evaluate the safety and efficacy of autologous bone marrow-derived DCs(CellgramDC-WT1) and immune checkpoint inhibitors in patients with metastatic pancreatic cancer who have failed first-line or more standard chemotherapy

Not Applicable
Conditions
Neoplasms
Registration Number
KCT0009102
Lead Sponsor
Soon Chun Hyang University Hospital Seoul
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
All
Target Recruitment
10
Inclusion Criteria

(1) 19 or older and under 80
(2) Patients diagnosed histologically with pancreatic cancer, recurrent, metastatic
(3) Patients confirmed to have progressed the disease in accordance with RECIST v1.1 after standard chemotherapy of primary or higher
(4) Patients who meet full-body performance status ECOG 0-2
(5) Patients with at least one measurable lesion according to RECIST v1.1
(6) Patients who have not received surgery, radiotherapy, or immunotherapy within the past 4 weeks and have recovered from side effects (However, tissue collection procedures that do not affect the condition of the subject are allowed at the discretion of the researcher)
(7) Patients who agreed to use medically recognized contraception during the clinical study participation period
(8) Patients who can conduct clinical research in accordance with the clinical research plan
(9) Patients who have agreed in writing to participate in this clinical study voluntarily

Exclusion Criteria

(1) Patients with malignant tumors other than non-melanoma skin cancer in the last 3 years
(2) Patients who have previously received anti-tumor immunotherapy (such as anti-PD1, anti-PDL-1 or CTLA4 inhibitor) or participated in clinical studies related to immunotherapy or cell therapy
(3) Patients with active autoimmune diseases requiring systemic immunosuppression therapy
(4) a patient with a history of organ or hematopoietic stem cell transplantation
(5) Patients with acute or chronic infections requiring systemic treatment
(6) a patient known to be positive for human immunodeficiency virus (HIV) infection/serum
(7) Patients with active hepatitis A, B or C
(8) an untreated syphilis patient
(9) Patients who received a live virus vaccine (e.g. measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, oral typhoid vaccine, Flu-Mist, etc.) within 30 days
(10) Pregnant or breastfeeding patient
(11) In addition, if the Tester deems that he/she is not suitable for clinical research

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
safety
Secondary Outcome Measures
NameTimeMethod
efficacy
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