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
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.
Inclusion Criteria:
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.
Exclusion Criteria:
Metastasis to other sites (liver, peritoneum, lung, bone, brain).
History of other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ).
Severe uncontrolled comorbidities (NYHA III/IV heart failure, unstable angina, uncontrolled arrhythmia/hypertension, active infection, uncontrolled diabetes, uncontrolled effusions/ascites requiring drainage, severe portal hypertension/cavernoma, gastric outlet obstruction, respiratory insufficiency requiring oxygen).
Major surgery within 30 days before screening.
EGFR monoclonal antibody within 30 days before screening.
Allergy to any drug or component used in this protocol.
Known HIV infection or chronic hepatitis B/C.
Unresolved toxicity ≥CTCAE grade 2 from prior treatment (except anemia, alopecia, skin pigmentation, chemotherapy-induced neurotoxicity).
Any other reason judged by the investigator to make participation inappropriate.