pancreatic cancer
Conditions
Interventions
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
s condition meets withdrawal criteria.
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 follow
Sponsors
Wakayama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival Response rate Adverse events Rate of dose limiting toxicity (first six patients in active group) | — |
Countries
Japan
Contacts
Public ContactMasahiro Katsuda
Wakayama Medical University Second Department of Surgery
Outcome results
None listed