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Exploratory Trial of Immunochemoradiotherapy for Locally Advanced Pancreatic Adenocarcinoma
This study will add an immunotherapy component to chemotherapy and radiation treatment in patients who have pancreatic cancer. The objective of this study is to see if the combined treatment is safe and feasible, and if a larger study is warranted.
Details
| Lead sponsor | Providence Health & Services |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 11 |
| Start date | 2011-01 |
| Completion | 2018-04 |
Conditions
- Locally Advanced Pancreatic Adenocarcinoma
Interventions
- tadalafil and vaccination
Primary outcomes
- Safety — 180 Days
Adverse events will be graded no less than weekly for the first 180 days. Post-treatment long-term follow-up will occur every 12 weeks beyond day 180 for 6 visits and then every 24 weeks thereafter until progressive disease, withdrawal from study or death. For this pilot study, adverse events and efficacy measures will be personally reviewed by the principal investigator. Both hematologic and non-hematologic toxicity will be anticipated. In conjunction with the IRB, stopping the trial will be among possible measures taken if undue toxicity or inadequate outcomes are observed.
Countries
United States