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

NCT04377048 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2020-05-06

No results posted yet for this study

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.

Conditions

  • Stage IV Pancreatic Cancer

Interventions

DRUG

Nivolumab

as described in "NGS Arm"

DRUG

Gemcitabine

as described in "NGS Arm"

DRUG

Tegafur-Gimeracil-Oteracil

as described in "NGS Arm"

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    collaborator INDUSTRY

  • ACT Genomics

    collaborator INDUSTRY

  • TTY Biopharm

    collaborator INDUSTRY

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Shih-Hung Yang, M.D., Ph.D. · Department of Oncology, National Taiwan University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-07-01
Completion
2022-12-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04377048 on ClinicalTrials.gov