Table 2.
Preclinical and clinical studies involving IRE in combination with chemotherapy.
| Type of Trial (Status) |
Trial Identifier | Phase | Patients Number | Short Description | Study Protocol | Study Outcomes | Side Effects | Ref. |
|---|---|---|---|---|---|---|---|---|
| Randomized (ongoing) |
KB-330/2018 | N/A | 13 | IRE + CaCl2 or CT in LAPC patients | i.t. CaCl2 (10 mM) + IRE: 10 pulses, 1.05–2.8 kV/cm, +/− intraoperative CSP |
N/A | N/A | [73,75] |
| Interventional Clinical Trial | NCT04093141 | N/A | 30 | CT followed by IRE in patients with unresectable LAPC | N/A | N/A | N/A | N/A |
| Non-randomized Prospective |
NCT02981719 | N/A | 68 | LAPC patients treated with GEM with concurrent IRE (n = 33) or GEM alone (n = 35) | i.v. GEM (1 g/m2) +/− IRE: 90 pulses, 1.5 kV/cm, PD = 70–90 ms + i.v. CT (GEM 1 g/m2) 2–4 WKs after IRE ablation 6 courses |
GEM: OS = 9.3 M, PFS = 8.3 M GEM + IRE: OS = 19.8 M, PFS = 4.7 M |
hypoalbuminemia, hemoglobin reduction |
[64] |
| Interventional Clinical Trial | NCT02514421 | I | 6 | Patients diagnosed with stage III pancreatic cancer treated with IRE prior to CT (GEM + nab-paclitaxel) | IRE +/− i.v. CT (GEM 1) g/m2; D: 1, 8, and 15 and nab-paclitaxel 0.125 g/m2; D: 1, 8, and 15) |
N/A | N/A | N/A |
| Randomized | NCT03673137 | II/III | 120 | LAPC patients treated with simultaneous GEM and IRE | IRE: 80 pulses, 1.5 kV/cm, PD = 90 ms +/− i.v. GEM (1 g/m2) |
N/A | N/A | N/A |
| Prospective | NCT03484299 | II | 20 | Patients with advanced pancreatic cancer treated with IRE in combination with either FOLFIRINOX or GEM | IRE: 100–300 pulses, 3 kV/cm, PD = 100 µs + i.v. GEM or FOLFIRINOX |
N/A | N/A | [24] |
i.v.—intravenous; i.t.—intratumoral; CSP—cisplatin; GEM—gemcitabine; CaCl2—calcium chloride; IRE—irreversible electroporation; OS—overall survival rate; WK—week; D—day; M—months; ms—milliseconds; LAPC—locally advanced pancreatic cancer; CT—chemotherapy; PD—pulse duration.