New way to deliver Gemcitabine directly to pancreatic tumors in non-resectable pancreatic cancer
Official title: A Single-center, Prospective, Non-randomized, Open, Pilot Study Evaluating the Safety and Performance of the Extroducer® Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Unresectable Locally Advanced Pancreatic Cancer
Run by Smartwise Sweden AB · NCT07575191 · Data updated 2026-11-12
This study tests a catheter-based method to deliver Gemcitabine straight into or near pancreatic tumors in locally advanced, unresectable cases.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 9 (estimated) |
| Sponsor | Smartwise Sweden AB Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Solna) |
| Status | Recruiting |
| Started | April 29, 2026 |
| Main results expected | December 2027 |
| Study ends | June 2028 |
| Registry record updated | June 12, 2026 |
| Trial ID | NCT07575191 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with histologically confirmed locally advanced, unresectable pancreatic cancer who have completed systemic IV chemotherapy and have ECOG 0–1.
✕Probably not a fit
Patients with significant comorbidities, poor performance status, metastatic disease, or intolerance to catheter-based procedures may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an early-phase, non-randomized study to evaluate the safety and feasibility of the Extroducer Infusion Catheter System for peri- and intratumoral delivery of Gemcitabine. Participants receive four treatment sessions every two weeks with escalating Gemcitabine doses (100 mg, 200 mg, 400 mg) across three sequential groups. Each group includes three patients, and an independent safety committee reviews results before moving to the next dose level. The trial follows patients for six months after treatment, for a total participation of about 8–9 months, at a single site in Sweden. The primary aim is to assess safety and feasibility of this delivery approach in locally advanced, unresectable pancreatic cancer.
Why it matters
Potential benefit: If successful, this approach could enable higher local drug concentrations with potentially improved tumor control for patients who cannot have surgery.
How similar studies have gone: Prior interest in catheter-based tumor delivery exists, but this specific peri-/intratumoral Gemcitabine delivery approach is exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to comply with scheduled visits, treatment plan, able to undergo catheterization, imaging procedures, laboratory tests, required follow up visits, the filling out of required forms, and have the ability to understand and give written informed consent. * Voluntarily agrees to participate and has duly singed the Informed Consent Form. * Age 18 years or older. * Histologically confirmed, locally advanced pancreatic cancer. * Systemic treatment with IV chemotherapy for at least six months. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * The target tumor is a measurable tumor according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1 prior to initiating Extroducer® Gemcitabine treatment. * Stable disease or locally progressive disease without signs of metastatic disease as evaluated at a multidisciplinary tumor board within 4 weeks prior to first dose. * Locally Advanced Pancreatic Cancer not amenable to resection as evaluated at a multidisciplinary tumor board within 4 weeks prior to first dose. * Have acceptable organ and marrow function as defined below: i. Absolute neutrophil count (ANC) ≥ 1500 cells/mm³ (1.5x109 cells/L) ii. Hemoglobin ≥ 9.0 g/dL iii. Platelets ≥ 100,000/µL iv. Total bilirubin ≤ 2 × upper limit of normal (ULN). v. AST (Aspartate Aminotransferase) ≤ 3 × ULN. vi. ALT (Alanine Aminotransferase) ≤ 3 × ULN vii. Creatinine Within 1.5 x ULN OR Creatinine clearance ≥ 60 mL/min for patients with creatinine levels above 1.5 x ULN. * Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to enrollment) must have a negative urine pregnancy test at enrollment and must agree to use a medically acceptable and highly effective contraception from enrollment until 6 months after final study treatment of Gemcitabine. * Male subjects who are planning to father a child (i.e., planning a pregnancy with a partner) during the clinical investigation. i. Male subjects must agree to use highly effective contraception with female partners of childbearing potential during the clinical investigation and for 3 months after the last dose of Gemcitabine and must not donate sperm during this period. ii. Acceptable methods include: a condom in addition to combined hormonal contraception, progestogen-only contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion in the female partner, or vasectomy of the male participant (confirmed azoospermia). iii. Sexual abstinence is acceptable only if it is the subject's usual and preferred lifestyle; periodic abstinence and withdrawal are not acceptable. Exclusion Criteria: * Participating in another clinical investigation which may interfere with the results in this clinical investigation per investigator judgement. * Inability to consent. * Pancreatic tumor is different from adenocarcinoma (e.g., neuroendocrine, metastases). Adenosquamous is allowed. * Cancer has spread to other organs or non-regional lymph nodes (Metastases). * Unknown stage or recurrent pancreatic cancer. * Patient contraindication to Gemcitabine treatments. * Patients in which iodine contrast is contraindicated. * Presence of structures that impede tumor access. * Concurrent or prior malignancy unless disease-free for ≥3 years, with exceptions for nonmelanoma skin cancer, carcinoma in situ of the cervix or bladder, or Gleason Grade \< 7 organ-confined prostate cancer. This may be subject to investigator's judgement based on individual patient circumstances and the nature of the malignancy. * Unmanaged concurrent illnesses, encompassing psychiatric conditions or challenging social circumstances, that, as per the investigator's judgment, could undermine compliance to the study protocols or pose an unacceptable risk to the patient. * Pregnant or nursing individuals.
Where it's running
-
Karolinska University Hospital
Solna, Sweden Recruiting
Study contacts
- Study coordinator: Ulrik Birgersson, PhD, MSc
- Email: Ulrik.Birgersson@smartcella.com
- Phone: +46 70 842 10 54
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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.