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

NCT07575191 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-05-08

No results posted yet for this study

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

Interventions

DRUG

Gemcitabine

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

DEVICE

Extroducer Infusion Catheter System

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

Sponsors & Collaborators

  • Smartwise Sweden AB

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07575191 on ClinicalTrials.gov