Table 2.
Major ongoing randomized trials of neoadjuvant treatments for borderline resectable pancreatic cancer
| Study | Treatments | Eligibility | Phase | No. of patients | Primary endpoint | Study Start | Estimated Study Completion | Country |
|---|---|---|---|---|---|---|---|---|
| UVA-PC-PD101 NCT02305186 | Radiation/capecitabine/pembrolizumab | R BR | Phase 1/2 | 56 | Number of tumor-infiltrating lymphocytes (TILs) | Mar 2015 | Dec 2020 | US |
| Radiation/capecitabine | ||||||||
| NCT02717091 | FOLFIRINOX | BR | Phase 2 | 50 | R0 resection rate | Jul 2015 | Jun 2020 | Japan |
| gemcitabine/nab-paclitaxel | ||||||||
| GABARNANCE Trial UMIN000026858 | S1 + radiation | BR | Phase 2/3 | 110 | Overall survival | Apr 2017 | Sep 2022 | Japan |
| Gemcitabine/nab-paclitaxel | ||||||||
| PANDAS-PRODIGE 44 NCT02676349 | mFOLFIRINOX + radiation/capecitabine | BR | Phase 2 | 90 | R0 resection rate | Oct 2016 | Jan 2026 | France |
| mFOLFIRINOX | ||||||||
| Alliance Trial A021501 NCT02839343 | mFOLFIRINOX + radiation | BR | Phase 2 | 126 | 18 months overall survival rate | Dec 2016 | Mar 2020 | Canada, US |
| mFOLFIRINOX | ||||||||
| BRPCNCC-1 NCT03777462 | Gemcitabine/nab-paclitaxel | BR | Phase 2 | 150 | Overall survival | Apr 2019 | Dec 2021 | China |
| Gemcitabine/nab-paclitaxel + radiation | ||||||||
| S1/Nab-paclitaxel + radiation | ||||||||
| NCT01458717 | radiation/gemcitabine | BR | Phase 2/3 | 58 | 2-year survival rate | Nov 2011 | Jan 2018 | Korea |
| Upfront surgery | ||||||||
| NEOLAP NCT02125136 | Gemcitabine/nab-paclitaxel | BR LA | Phase 2 | 168 | Conversion rate | Nov 2014 | Oct 2020 | US |
| Gemcitabine/nab-paclitaxel + mFOLFIRINOX | ||||||||
| NCT03983057 | mFOLFIRINOX/Anti-PD-1 antibody | BR LA | Phase 3 | 830 | Progression-free survival | Apr 2019 | Apr 2021 | China |
| mFOLFIRINOX |
R resectable, BR borderline resectable, LA locally advanced, mFOLFIRINOX modified-FOLFIRINOX