NH002-mediated Sonoporation With Chemotherapy in Advanced Pancreatic Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNational Taiwan University Hospital
About this trial
This is a phase I study that will enroll patients with pancreatic cancer and liver metastasis who have failed prior gemcitabine-based chemotherapy. Patients will be treated with nanoliposomal irinotecan plus 5-FU and leucovorin and NH002-based sonoporation to the liver metastasis.
Eligibility criteria
Qualifiers
Dated and signed informed consent
Either sex, aged 18 to 80 years old (inclusive) at the date of consent
With histologically or cytologically confirmed PDAC
With life expectancy at least 12 weeks
Disqualifiers
Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity within 28 days before screening
Presence of diarrhea at least grade 2 based on CTCAE v.5.0
Concomitant systemic infection requiring treatment
Myocardial infarction within 180 days before screening
Trial design
Treatments tested in this trial
- nanoliposomal irinotecan+5-FU+leucovorin
- NH002 (Perflutren Lipid Microspheres) Injectable Suspension
- Aco Apache Ultrasound
Treatment groups
24 Participants
are divided into 4 treatment groupsSponsors and collaborators
National Taiwan University Hospital
Lead sponsor
Trust Bio-sonics, Inc.
Collaborator
Source ClinicalTrials.gov