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Nivolumab Adding on Gemcitabine/S-1 in Metastatic Pancreatic Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

Nivolumab as add-on to Gemcitabine/S-1 in Metastatic Pancreatic Cancer: a Phase II Trial

NCT04377048•National Taiwan University Hospital

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 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.

Eligibility

Age

20 - 75 years

Sex

ALL

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
+4 more criteria

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
+14 more criteria

Key Dates

Start Date

July 1, 2020

Primary Completion Date

July 1, 2022

Completion Date

December 31, 2022

Last Updated

May 6, 2020

Enrollment

ESTIMATED participants

Conditions

Stage IV Pancreatic Cancer

Interventions

Nivolumab

DRUG

Gemcitabine

DRUG

Tegafur-Gimeracil-Oteracil

DRUG

Contacts

Shu-Ling Wu

CONTACT

+886-2-23123456 shulingwu.ntuh@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 6, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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