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

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

Trial Details

NCT ID
NCT07575191
Phase
PHASE1 / PHASE2
Sponsor
Smartwise Sweden AB
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • Gemcitabine
  • Extroducer Infusion Catheter System
Locations (sample)
  • Solna, Sweden|59.36004,18.00086

Key Eligibility Criteria

  • Able to comply with scheduled visits, treatment plan, able to undergo catheterization, imaging procedures, laboratory tests, required follow up vis…
  • Voluntarily agrees to participate and has duly singed the Informed Consent Form.
  • Age 18 years or older.
  • Histologically confirmed, locally advanced pancreatic cancer.

For full eligibility, visit ClinicalTrials.gov.

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