Table 1.
Clinical trials assessing stroma-targeting therapy in PDAC.
| Target | Agents | Patient population | Trial phase | mPFS (months) | mOS (months) | Status | NIH number |
|---|---|---|---|---|---|---|---|
| HA | PEGPH20 + GEM + nab-paclitaxel vs GEM + nab-paclitaxel | Metastatic PDAC | Phase II | 6.0 vs 5.3 | 9.6 vs 9.2 | Completed | NCT01839487 |
| PEGPH20 + GEM + nab-paclitaxel vs GEM + nab-paclitaxel | Metastatic PDAC (HA-High) | Phase II | 9.2 vs 5.2 | 11.5 vs 8.5 | Completed | NCT01839487 | |
| PEGPH20 + GEM + nab-paclitaxel vs GEM + nab-paclitaxel | Metastatic PDAC (HA-High) | Phase III | 7.1 vs 7.1 | 11.2 vs 11.5 | Terminated | NCT02715804 | |
| PEGPH20 + FOLFIRINOX vs FOLFIRINOX | Metastatic PDAC | Phase Ib/II | 4.3 vs 6.2 | 7.7 vs 14.4 | Terminated | NCT01959139 | |
| Hedgehog | IPI-926 | Solid tumors (including PDAC) |
Phase I | – | – | Completed | NCT00761696 |
| IPI-926 + GEM vs GEM | Metastatic PC | Phase Ib/II | The former < the latter | The former < the latter | Completed | NCT01130142 | |
| IPI-926+ FOLFIRINOX | Locally advanced or metastatic PDAC | Phase Ib | 8.4 | – | Completed | NCT01383538 | |
| Vismodegib + GEM vs GEM | Metastatic PC | Phase Ib/II | 4.0 vs 2.5 | 6.9 vs 6.1 | Completed | NCT01064622 | |
| Vismodegib +GEM | Metastatic PC | Phase II | 2.8 | 5.3 | Completed | NCT01195415 | |
| Vismodegib +GEM + nab-paclitaxel | Metastatic PDAC | Phase II | 5.42 | 9.79 | Completed | NCT01088815 | |
| Sonidegib + GEM | Locally advanced or metastatic PDAC | Phase Ib | 4.9 | – | Completed | NCT01487785 | |
| CTGF | Pamrevlumab + GEM + nab-paclitaxel vs GEM + nab-paclitaxel | Locally advanced PDAC | Phase I/II | – | – | Completed | NCT02210559 |
| Pamrevlumab + GEM + nab-paclitaxel vs GEM + nab-paclitaxel | Locally advanced PDAC | Phase III | – | – | Recruiting | NCT03941093 | |
| Pamrevlumab + GEM + erlotinib | Locally advanced or metastatic PDAC | Phase I | 4.3 | 9.4 | Completed | NCT01181245 | |
| R-A system | Losartan + FOLFIRINOX + chemoradiotherapy | Locally advanced PDAC | Phase II | 17.5 | 31.4 | Completed | NCT01821729 |
| Losartan + nivolumab + FOLFIRINOX + SBRT | Localized PDAC (Borderline/potentially resectable or locally advanced) | Phase II | – | – | Recruiting | NCT03563248 | |
| – | UM + GEM | Locally advanced or metastatic PDAC | Phase I | – | 17.6 vs 8.9 | Completed | NCT01674556 |
CTGF, connective tissue growth factor; DDR1, discoidin domain receptor 1; FOLFIRINOX, 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan; GEM, gemcitabine; HA, hyaluronic acid; NIH, National Institutes of Health; mOS, median overall survival; PC, pancreatic cancer; PDAC, pancreatic ductal adenocarcinoma; mPFS, median progression-free survival; R-A system, renin-angiotensin system; SBRT, stereotactic body radiation therapy; UM, ultrasound microbubbles.