Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer

NCT07575191 | Not Yet Recruiting Phase 1 DMC

• 3 other identifiers: nEXT-GEM2025-524733-11-0025-10-054715
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study is testing a new way to deliver the chemotherapy drug Gemcitabine in pancreatic tumors using the catheter Extroducer® Infusion Catheter System. The study will include patients with Locally Advanced Pancreatic Cancer that cannot be removed with surgery. Patients will receive four treatment sessions, given every two weeks, in which Gemcitabine is infused directly into or near the tumor. The study will test up to three increasing dose levels of Gemcitabine (200 mg, 400 mg, and 100 mg). The study will enroll three groups of three patients each. After each group completes treatment, an independent safety committee will review the results to decide whether it is safe to move to the next dose per predefined study criteria. After finishing treatment, patients will be followed for six months. Each patient's total participation in the study will last about 8-9 months. The main goal of the study is to evaluate the safety and feasibility of this treatment approach.

Conditions

Pancreatic Cancer Non-resectable

Outcome Measures

Primary Outcomes (1)

• Extroducer® related Serious Adverse Events

  Occurrence of Extroducer® related Serious Adverse Events within 72 hours post Extroducer® treatment infusion with Gemcitabine.

  From each study treatment until 72 hours post treatment.

Secondary Outcomes (8)

• Gemcitabine related Serious Adverse Events

  From first study treatment on Day 0 until study completion, ~8 Months.

• Overall Survival

  Through study completion, ~8 Months.

• Progression Free Survival

  Through study completion, ~8 Months.

• Tumor resectability

  Through study completion, ~8 Months.

• Tumor response

  Through study completion, ~8 Months.

Study Arms (1)

Sequential targeted Gemcitabine delivery

EXPERIMENTAL

Participants receive Gemcitabine administered via the Extroducer® Infusion Catheter System for targeted intra-arterial delivery, according to a predefined sequential treatment protocol.

Drug: Gemcitabine; Device: Extroducer Infusion Catheter System

Interventions

Gemcitabine DRUG

Gemcitabine administered via the Extroducer Infusion Catheter System for targeted delivery.

Sequential targeted Gemcitabine delivery

Extroducer Infusion Catheter System DEVICE

Infusion catheter system for delivery of diagnostic or therapeutic agents into the extravascular space or peripheral vasculature.

Sequential targeted Gemcitabine delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smartwise Sweden AB: lead

Study Sites (1)

Karolinska University Hospital

Solna, 171 64, Sweden

Location

MeSH Terms

Interventions

Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Ulrik Birgersson, PhD, MSc

CONTACT

+46 70 842 10 54; Ulrik.Birgersson@smartcella.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: May 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

SE (1)