Stage IV Pancreatic CancerPhase 2NCT04377048
Nivolumab Adding on Gemcitabine/S-1 in Metastatic Pancreatic Cancer
A Phase 2 study testing Nivolumab, Gemcitabine and Tegafur-Gimeracil-Oteracil in people with Stage IV Pancreatic Cancer, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Stage IV Pancreatic Cancer
- What is being tested?
- Nivolumab, Gemcitabine and Tegafur-Gimeracil-Oteracil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Nivolumab as add-on to Gemcitabine/S-1 in Metastatic Pancreatic Cancer: a Phase II Trial
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.
- Conditions
- Stage IV Pancreatic Cancer
- Being tested
- Nivolumab, Gemcitabine, Tegafur-Gimeracil-Oteracil
- Keywords
- pancreatic adenocarcinoma, chemotherapy, nivolumab
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
as described in "NGS Arm"
GemcitabineDrug
as described in "NGS Arm"
Tegafur-Gimeracil-OteracilDrug
Also called S-1
as described in "NGS Arm"
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab/GS | Experimental | 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: 850 mg/m2; D1, 8; 3 weeks per cycle
* After GS, patients fulfilling the pre-defined CA 19-9 criteria will enter the Add-On part.
Part-2: Nivolumab Add-On
* Nivolumab: 3 mg/kg every 2 weeks, 6 weeks per cycle
* S-1: according to the individualized dose on D8 of cycle 1 in Part-1, 6 weeks per cycle
* Gemcitabine: according to the individualized dose on D8 of cycle 1 in Part-1, 6 weeks per cycle
The treatment will be continued until disease progression, intolerance to study treatment or death. Receives: Drug: Nivolumab; Drug: Gemcitabine; Drug: Tegafur-Gimeracil-Oteracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
overall response rate of gemcitabine/S-1/nivolumab
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Jul 2020 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stage IV Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Simon's two-stage design
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ono Pharmaceutical Co., Ltd., ACT Genomics, TTY Biopharm
- Responsible party
- Sponsor
- Investigators
- Shih-Hung Yang, M.D., Ph.D., Principal investigator, Department of Oncology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377048
- Sponsor's protocol ID
- 202001045MIPA
- Status last verified
- May 2020
- First submitted
- 4 May 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23547081Weiss 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.
PubMed 29119276Yang SH, Chen BB, Lee JC, Kuo YT, Kuo SH, Cheng AL, Yeh KH. Incorporating nivolumab with preceded gemcitabine and S-1 chemotherapy for patients of metastatic pancreatic cancer: a pilot study. Am J Cancer Res. 2025 Sep 25;15(9):4108-4120. doi: 10.62347/NJOX8790. eCollection 2025.
PubMed 41113977
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nivolumab as add-on to Gemcitabine/S-1 in Metastatic Pancreatic Cancer: a Phase II Trial
- ClinicalTrials.gov ID
- NCT04377048
- Acronym / sponsor ID
- 202001045MIPA
- Conditions
- Stage IV Pancreatic Cancer
- Keywords
- pancreatic adenocarcinoma, chemotherapy, nivolumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Ono Pharmaceutical Co., Ltd., ACT Genomics, TTY Biopharm
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Simon's two-stage design
| Arm | Type | Receives |
|---|---|---|
| Nivolumab/GS | Experimental | Drug: Nivolumab, Drug: Gemcitabine, Drug: Tegafur-Gimeracil-OteracilPart-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: 850 mg/m2; D1, 8; 3 weeks per cycle * After GS, patients fulfilling the pre-defined CA 19-9 criteria will enter the Add-On part. Part-2: Nivolumab Add-On * Nivolumab: 3 mg/kg every 2 weeks, 6 weeks per cycle * S-1: according to the individualized dose on D8 of cycle 1 in Part-1, 6 weeks per cycle * Gemcitabine: according to the individualized dose on D8 of cycle 1 in Part-1, 6 weeks per cycle The treatment will be continued until disease progression, intolerance to study treatment or death. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumabas described in "NGS Arm" | Drug | Nivolumab/GS |
| Gemcitabineas described in "NGS Arm" | Drug | Nivolumab/GS |
| Tegafur-Gimeracil-OteracilAlso: S-1as described in "NGS Arm" | Drug | Nivolumab/GS |
Primary outcome
response rate
Time frame: 6 weeks
overall response rate of gemcitabine/S-1/nivolumab
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Results publication: PubMed 23547081Ueno 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.
- Results publication: PubMed 29119276Weiss 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.
- Derived from this study: PubMed 41113977Yang SH, Chen BB, Lee JC, Kuo YT, Kuo SH, Cheng AL, Yeh KH. Incorporating nivolumab with preceded gemcitabine and S-1 chemotherapy for patients of metastatic pancreatic cancer: a pilot study. Am J Cancer Res. 2025 Sep 25;15(9):4108-4120. doi: 10.62347/NJOX8790. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shih-Hung Yang, M.D., Ph.D. principal investigator
Department of Oncology, National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, Gemcitabine and Tegafur-Gimeracil-Oteracil in people with Stage IV Pancreatic Cancer, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Ling Wu (+886-2-23123456 ext. 67573, shulingwu.ntuh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04377048, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.