IRE After Chemotherapy for Locally Advanced Pancreatic Cancer
Recruiting · NCT07799935 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- Refusal to receive systemic chemotherapy or possible surgery.
- 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.
Where it is running
1 location listed.
- Tianjin Cancer Hospital Airport Hospital - Tianjin, Tianjin Municipality, China