$0.00
Shopping Cart
Facebook-f Instagram
DONATE
Donate

Clinical Trial Record

Return to Clinical Trials

Nivolumab Adding on Gemcitabine/S-1 in Metastatic Pancreatic Cancer

2020-07-01

2022-07-01

2022-12-31

38

Study Overview

Nivolumab Adding on Gemcitabine/S-1 in Metastatic Pancreatic Cancer

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 load, adequate organ function, and slow growth of the tumor are the key points. Stage IV pancreatic adenocarcinoma patients with limited metastatic lesions and adequate organ function will be enrolled. Gemcitabine plus S-1 (GS) will be administered initially, and then CA 19-9 will be evaluated. Those fulfilling pre-defined criteria of CA 19-9 will receive nivolumab add-on therapy.

N/A

  • Stage IV Pancreatic Cancer
  • DRUG: Nivolumab
  • DRUG: Gemcitabine
  • DRUG: Tegafur-Gimeracil-Oteracil
  • 202001045MIPA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2020-05-04  

N/A  

2020-05-04  

2020-05-04  

N/A  

2020-05-06  

2020-05-06  

N/A  

2020-05  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Nivolumab/GS

Part-1: GS Induction * Patients will receive GS for 1 cycle. * S-1: 60/80/100 mg per day (based on body surface area, BSA); D1-12; 3 weeks per cycle * BSA < 1.25 m2: 60 mg/day; 1.25 m2 ≤ BSA < 1.5 m2: 80 mg/day; BSA ≥ 1.5 m2: 100 mg/day * Gemcitabine: 85

DRUG: Nivolumab

  • as described in "NGS Arm"

DRUG: Gemcitabine

  • as described in "NGS Arm"

DRUG: Tegafur-Gimeracil-Oteracil

  • as described in "NGS Arm"
Primary Outcome MeasuresMeasure DescriptionTime Frame
response rateoverall response rate of gemcitabine/S-1/nivolumab6 weeks
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Shu-Ling Wu

Phone Number: +886-2-23123456

Email: shulingwu.ntuh@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. histologically proven pancreatic adenocarcinoma 2. newly diagnosed, stage IV pancreatic cancer with limited metastases and tumor burden 3. 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 4. presence of at least one measurable lesion at the pancreas and at least one measurable metastatic lesion 5. age between 20 and 75 years at registration 6. ECOG performance status of 0 or 1 7. adequate major organ functions 8. baseline CA 19-9 > upper limit of normal 9. Glasgow prognostic score of 0 (ie. albumin ≥ 3.5 g/dL and CRP ≤ 1 mg/dL) 10. ability to take study medication (S-1) orally 11. no clinically significant abnormal ECG findings within 28 days prior to registration 12. 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. 13. 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. 14. Sign written informed consent
    Exclusion Criteria:
    1. 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 2. presence of diarrhea ≥ CTCAE v.5.0 grade 2 3. concomitant systemic infection requiring treatment 4. clinically significant co-morbid medical conditions, including cardiovascular disease known autoimmune disease 5. concurrent autoimmune disease or history of chronic or recurrent autoimmune disease 6. prior organ allograft or allogeneic bone marrow transplantation 7. received systemic corticosteroids (except for temporary use, e.g., for examination or prophylaxis of allergic reactions) or immunosuppressants within 28 days before registration 8. HBV (positive HBsAg or HBV DNA) or HCV carrier (positive anti-HCV or HCV RNA) 9. known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome 10. moderate or severe ascites, pleural effusion, or pericardial effusion requiring treatment 11. central nervous system metastasis 12. prior or concurrent malignancies within the last 3 years, with the exception of carcinoma in situ of the cervix, or basal type skin cancer 13. concomitant treatment with flucytosine, phenytoin or warfarin 14. 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. 15. transfusion from 72 hours prior to registration to the first dose of study drug administration 16. pregnant women or nursing mothers, or positive pregnancy tests 17. severe mental disorder 18. 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 19. vaccine therapies for prevention of infectious diseases within 4 weeks of study drug administration except inactivated seasonal influenza vaccine 20. any condition requiring anti-platelet or anticoagulant therapy within 12 weeks prior to registration 21. oral or iv antibiotic use within 2 weeks prior to registration 22. uncontrollable pain caused by a tumor 23. receiving antineoplastic agents within 28 days before registration 24. patients judged by the principal investigator or subinvestigators to be inappropriate as subjects of this study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Ono Pharmaceutical Co. Ltd
  • ACT Genomics
  • TTY Biopharm
  • PRINCIPAL_INVESTIGATOR: Shih-Hung Yang, M.D., Ph.D., Department of Oncology, National Taiwan University Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Ueno H, Ioka T, Ikeda M, Ohkawa S, Yanagimoto H, Boku N, Fukutomi A, Sugimori K, Baba H, Yamao K, Shimamura T, Sho M, Kitano M, Cheng AL, Mizumoto K, Chen JS, Furuse J, Funakoshi A, Hatori T, Yamaguchi T, Egawa S, Sato A, Ohashi Y, Okusaka T, Tanaka M. Randomized phase III study of gemcitabine plus S-1, S-1 alone, or gemcitabine alone in patients with locally advanced and metastatic pancreatic cancer in Japan and Taiwan: GEST study. J Clin Oncol. 2013 May 1;31(13):1640-8. doi: 10.1200/JCO.2012.43.3680. Epub 2013 Apr 1.
  • Weiss GJ, Blaydorn L, Beck J, Bornemann-Kolatzki K, Urnovitz H, Schutz E, Khemka V. Phase Ib/II study of gemcitabine, nab-paclitaxel, and pembrolizumab in metastatic pancreatic adenocarcinoma. Invest New Drugs. 2018 Feb;36(1):96-102. doi: 10.1007/s10637-017-0525-1. Epub 2017 Nov 8.
Treat yourself

Let Us Take Care Of You

BOOK AN APPOINTMENT ⟶
footer logo

About

Events

Fundraising

Contact Us

Facebook-f Instagram

NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.

The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

Copyright © 2025 – National Pancreatic Cancer Foundation | All Rights Reserved

Make-A-Will Month

Snag 6508be92
Learn More
Donate Now Online
Other Ways to Donate