Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

histologically proven pancreatic adenocarcinoma
newly diagnosed, stage IV pancreatic cancer with limited metastases and tumor burden
no previous radiotherapy, chemotherapy, targeted therapy, curative surgery, local therapy (eg. radiofrequency ablation, irreversible electroporation, etc.), immunotherapy, cell therapy (autologous or allogenic) used for pancreatic cancer
presence of at least one measurable lesion at the pancreas and at least one measurable metastatic lesion
age between 20 and 75 years at registration
ECOG performance status of 0 or 1
adequate major organ functions
baseline CA 19-9 > upper limit of normal
Glasgow prognostic score of 0 (ie. albumin ≥ 3.5 g/dL and CRP ≤ 1 mg/dL)
ability to take study medication (S-1) orally
no clinically significant abnormal ECG findings within 28 days prior to registration
Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons) must agree to use contraception from the time of informed consent until 5 months or more after the last dose of investigational products. Also, women must agree not to breastfeed from the time of informed consent until 5 months or more after the last dose of the investigational product.
Men must agree to use contraception from the start of study treatment until 7 months or more after the last dose of the investigational product.
Sign written informed consent

Exclusion Criteria:

interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity within 28 days prior to registration
presence of diarrhea ≥ CTCAE v.5.0 grade 2
concomitant systemic infection requiring treatment
clinically significant co-morbid medical conditions, including cardiovascular disease known autoimmune disease
concurrent autoimmune disease or history of chronic or recurrent autoimmune disease
prior organ allograft or allogeneic bone marrow transplantation
received systemic corticosteroids (except for temporary use, e.g., for examination or prophylaxis of allergic reactions) or immunosuppressants within 28 days before registration
HBV (positive HBsAg or HBV DNA) or HCV carrier (positive anti-HCV or HCV RNA)
known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
moderate or severe ascites, pleural effusion, or pericardial effusion requiring treatment
central nervous system metastasis
prior or concurrent malignancies within the last 3 years, with the exception of carcinoma in situ of the cervix, or basal type skin cancer
concomitant treatment with flucytosine, phenytoin or warfarin
any major surgery within 4 weeks of study treatment. Participants must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of study treatment.
transfusion from 72 hours prior to registration to the first dose of study drug administration
pregnant women or nursing mothers, or positive pregnancy tests
severe mental disorder
treatment with botanical preparations (eg, herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to registration
vaccine therapies for prevention of infectious diseases within 4 weeks of study drug administration except inactivated seasonal influenza vaccine
any condition requiring anti-platelet or anticoagulant therapy within 12 weeks prior to registration
oral or iv antibiotic use within 2 weeks prior to registration
uncontrollable pain caused by a tumor
receiving antineoplastic agents within 28 days before registration
patients judged by the principal investigator or subinvestigators to be inappropriate as subjects of this study