NCT07799935Recruiting
IRE After Chemotherapy for Locally Advanced 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
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 28 Aug 2026
- Start date
- 20 May 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Pancreatic cancer
- NCT number
- NCT07799935
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 20 May 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Cancer Hospital Airport Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.