Trials / Unknown
UnknownNCT04377048
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- Sponsor
- National Taiwan University Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nivolumab | as described in "NGS Arm" |
| DRUG | Gemcitabine | as described in "NGS Arm" |
| DRUG | Tegafur-Gimeracil-Oteracil | as described in "NGS Arm" |
Timeline
- Start date
- 2020-07-01
- Primary completion
- 2022-07-01
- Completion
- 2022-12-31
- First posted
- 2020-05-06
- Last updated
- 2020-05-06
Source: ClinicalTrials.gov record NCT04377048. Inclusion in this directory is not an endorsement.