IRE after chemotherapy for locally advanced pancreatic cancer
Official title: 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
Run by Tianjin Medical University Cancer Institute and Hospital · NCT07799935 · Data updated 2026-11-12
This study tests whether adding irreversible electroporation after chemotherapy helps people with locally advanced pancreatic cancer who can’t be surgically removed.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Status | Recruiting |
| Started | May 20, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | September 2, 2026 |
| Trial ID | NCT07799935 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-75 with histologically confirmed pancreatic adenocarcinoma, locally advanced disease unresectable by MDT, non-progressive after three cycles of chemotherapy, measurable lesions, good organ function, ECOG 0-1, and consent to participate.
✕Probably not a fit
Patients whose disease does not respond to IRE or those intolerant to the added procedure may not experience benefit and could incur added risks.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized study enrolls about 60 adults with locally advanced pancreatic cancer who have not progressed after three cycles of chemotherapy. Participants are randomized in a 2:1 ratio to receive open irreversible electroporation (IRE) in addition to continuing their chemotherapy, or to continue chemotherapy alone. Outcomes include overall survival, progression-free survival, tumor response, quality of life, safety, and postoperative results. Eligible patients must have unresectable tumors, measurable disease, adequate organ function, good performance status, and provide informed consent. The trial is conducted at Tianjin Medical University Cancer Institute and Hospital and Tianjin Cancer Hospital Airport Hospital in Tianjin, China.
Why it matters
Potential benefit: If successful, the approach could improve survival and disease control for patients with unresectable, locally advanced pancreatic cancer who have already responded to chemotherapy.
How similar studies have gone: Prior studies exploring local control with IRE in pancreatic cancer have shown mixed results, making this approach exploratory but grounded in existing experience with IRE in solid tumors.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
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Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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IRE after targeted immunotherapy in HCC with portal vein tumor thrombus
This study tests whether adding irreversible electroporation (IRE) after a targeted immunotherapy regimen helps people with liver cancer and portal vein tumor thrombus who can’t have surgery.
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IRE after chemotherapy for locally advanced unresectable perihilar cholangiocarcinoma
This study tests irreversible electroporation plus chemotherapy after induction therapy in adults with unresectable, non-progressing perihilar cholangiocarcinoma to see if local disease control improves.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.