Status:
UNKNOWN
Nivolumab Adding on Gemcitabine/S-1 in Metastatic Pancreatic Cancer
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
Ono Pharmaceutical Co. Ltd
ACT Genomics
Conditions:
Stage IV Pancreatic Cancer
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
This study assumes that to achieve significant therapeutic efficacy in advanced pancreatic cancer with immunotherapy, the immune system must remain relatively intact. Therefore, early use, low tumor l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04377048
Start Date
July 1 2020
End Date
December 31 2022
Last Update
May 6 2020
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