Table 1.
Ongoing clinical trials for neoadjuvant, adjuvant and combination with immunotherapy for resectable, borderline resectable and locally advanced pancreatic adenocarcinoma (www.clinicaltrials.gov)
| Trial name and ID | Patient’s resectability | Phase | n | Neoadjuvant | Adjuvant | Combination with immunotherapy | Status | NCT no |
|---|---|---|---|---|---|---|---|---|
| PANACHE01: Neo-adjuvant FOLF(IRIN)OX for resectable pancreatic adenocarcinoma | rPDAC | II | 160 | + | − | − | Recruiting | NCT02959879 |
| CISPD-1: sequential use of Gem/nab-P and mFOLFIRINOX as neoadjuvant CTX | rPDAC | II | 416 | + | − | − | Recruiting | NCT03750669 |
| NEPAFOX: randomized multicentre phase ii/iii study with adjuvant gemcitabine versus neoadjuvant/adjuvant folfirinox for resectable pancreas carcinoma | rPDAC | II/III | 40 | + | + | − | Active, not recruiting | NCT02172976 |
| NEONAX: neoadjuvant plus adjuvant or only adjuvant Gem/nab-P (17) | rPDAC | II | 166 | + | + | − | Active, not recruiting | NCT02047513 |
| SWOG 1505: perioperative mFOLFIRINOX vs. Gem/nab-P | rPDAC | II | 112 | + | − | − | Active, not recruiting | NCT02562716 |
| Neoadjuvant/adjuvant GVAX pancreas vaccine (With CY) with or without nivolumab and urelumab trial for surgically resectable pancreatic cancer | rPDAC | I/II | 62 | + | + | − | Recruiting | NCT02451982 |
| Perioperative therapy for resectable and borderline-resectable pancreatic adenocarcinoma with molecular correlates | rPDAC and brPDAC | II | 50 | + | − | − | Recruiting | NCT02723331 |
| nITRo: nal-IRI/5-FU/LV and oxaliplatin | rPDAC | II | 67 | + | − | − | Recruiting | NCT03528785 |
| Nivolumab in combination with chemotherapy before surgery in treating patients with borderline resectable pancreatic cancer | brPDAC | I/II | 36 | + | − | − | Recruiting | NCT03970252 |
| Study of pembrolizumab with or without defactinib following chemotherapy as a neoadjuvant and adjuvant treatment for resectable pancreatic ductal adenocarcinoma | rPDAC | II | 36 | + | + | + | Recruiting | NCT03727880 |
| Alternative neoadjuvant chemotherapy in resectable and borderline resectable pancreatic cancer | rPDAC and brPDAC | I | 30 | + | − | − | Recruiting | NCT03703063 |
| Nalirinox neo-pancreas RAS Mut ctDNA study | rPDAC | II | 20 | + | − | − | Recruiting | NCT04010552 |
| Testing the use of the usual chemotherapy before and after surgery for removable pancreatic cancer | rPDAC | III | 352 | + | − | − | Not yet recruiting | NCT04340141 |
| Study evaluating neoadjuvant immunotherapy in resectable pancreatic ductal adenocarcinoma | rPDAC | II | 40 | + | + | + | Recruiting | NCT03979066 |
| Study of NAC of GA therapy for patients with BRPC | brPDAC | II | 60 | + | − | − | Recruiting | NCT02926183 |
| PRIMUS002: looking at two neo-adjuvant treatment regimens for resectable and borderline resectable pancreatic cancer | rPDAC and brPDAC | II | 278 | + | − | − | Recruiting | NCT04176952 |
| Pre-operative treatment for patients with untreated pancreatic cancer | rPDAC and brPDAC | II | 24 | + | − | − | Recruiting | NCT03138720 |
| Testing the combination of two approved chemotherapy drugs and radiation prior to surgery in localized pancreatic cancer | LAPC | II | 30 | + | + | − | Recruiting | NCT03492671 |
| Trial of neoadjuvant and adjuvant nivolumab and bms-813160 with or without gvax for locally advanced pancreatic ductal adenocarcinomas | LAPC | I/II | 30 | + | + | + | Recruiting | NCT03767582 |
| Pooled mutant KRAS-targeted long peptide vaccine combined with nivolumab and ipilimumab for patients with resected MMR-p colorectal and pancreatic cancer | MMR-p PDAC | I | 30 | − | + | + | Not yet recruiting | NCT04117087 |
| VX15/2503 and immunotherapy in resectable pancreatic and colorectal cancer | rPDAC | I | 32 | + | − | + | Recruiting | NCT03373188 |
| BMS-813160 with nivolumab and gemcitabine and nab-paclitaxel in borderline resectable and locally advanced pancreatic ductal adenocarcinoma (PDAC) | brPDAC and LAPC | I/II | 53 | + | − | + | Recruiting | NCT03496662 |
PDAC pancreatic ductal adenocarcinoma, rPDAC resectable PDAC, brPDAC borderline resectable PDAC, LAPC locally advanced PDAC, MMR-p mismatch repair-proficient, Gem/nab-P gemcitabine/nab-paclitaxel, NAC neoadjuvant gemcitabine/nab-paclitaxel