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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer

NCT03697564

Pancreatic Cancer Stage IV

COMPLETED PHASE2

Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread

NCT04233866

Metastatic Pancreatic Adenocarcinoma Stage IV Pancreatic Cancer AJCC v8

ACTIVE_NOT_RECRUITING PHASE2

Testing the Combination of Anetumab Ravtansine With Either Nivolumab, Nivolumab and Ipilimumab, or Gemcitabine and Nivolumab in Advanced Pancreatic Cancer

NCT03816358

Pancreatic Adenocarcinoma Stage II Pancreatic Cancer AJCC v8 Stage III Pancreatic Cancer AJCC v8 +1 more

ACTIVE_NOT_RECRUITING PHASE1

Phase II Gemcitabine + Fractionated Stereotactic Radiotherapy for Unresectable Pancreatic Adenocarcinoma

NCT01146054

Pancreatic Cancer

COMPLETED PHASE2

Phase 2 Trial of Gemcitabine vs S-1 vs Gemcitabine Plus Nab-paclitaxel as Adjuvant Chemotherapy of Post-operative Pancreatic Cancer Patients

NCT03278015

Cancer of Pancreas

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stage IV Pancreatic Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Simon's two-stage design

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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: 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.

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

as described in "NGS Arm"

Gemcitabine

Intervention Type DRUG

as described in "NGS Arm"

Tegafur-Gimeracil-Oteracil

Intervention Type DRUG

as described in "NGS Arm"

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nivolumab

as described in "NGS Arm"

Intervention Type DRUG

Gemcitabine

as described in "NGS Arm"

Intervention Type DRUG

Tegafur-Gimeracil-Oteracil

as described in "NGS Arm"

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

S-1

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No