A Prospective, Randomized Controlled Phase II Clinical Study on Sequential or Non-Sequential Irreversible Electroporation Ablation After Chemotherapy Induction in Patients With Locally Advanced Unresectable Pancreatic Cancer
This is a prospective, randomized, controlled, exploratory Phase II clinical study. Approximately 60 eligible patients with locally advanced pancreatic cancer who have received three cycles of chemotherapy induction and have non-progressive disease will be enrolled. All patients must be considered unresectable by MDT review and must provide written informed consent. Participants will be randomized 2:1. Forty patients will undergo open IRE followed by continuation of the original chemotherapy regimen; twenty patients will continue the original treatment regimen alone. OS, PFS, tumor response, QoL, safety, and postoperative outcomes will be observed.
• Age 18-75 years, any sex.
⁃ Primary tumor biopsy confirms pancreatic adenocarcinoma.
⁃ Non-progressive disease (PR or SD) after three cycles of chemotherapy induction.
⁃ Locally advanced pancreatic cancer with \>180-degree involvement of major vessels (celiac axis, superior mesenteric artery, superior mesenteric vein, or portal vein), confirmed unresectable by MDT review.
⁃ No prior palliative chemotherapy (except neoadjuvant/adjuvant chemotherapy discontinued \>6 months); no other systemic antitumor therapy.
⁃ At least one measurable lesion per RECIST 1.1.
⁃ Adequate organ and marrow function: hemoglobin ≥9.0 g/dL; neutrophils ≥1.5×10⁹/L; platelets ≥100×10⁹/L; TBIL ≤3×ULN; AST and ALT ≤5.0×ULN; serum creatinine ≤1.5×ULN or CrCl \>60 mL/min.
⁃ ECOG Performance Status 0-1.
⁃ Expected survival ≥3 months.
⁃ Patients of childbearing potential and partners agree to use contraception.
⁃ Voluntary written informed consent.