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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
nanoliposomal irinotecan+5-FU+leucovorin
Drugnanoliposomal irinotecan 70 mg/m2 5-FU 2400 mg/m2 Leucovorin 400 mg/m2
NH002 (Perflutren Lipid Microspheres) Injectable Suspension
Drug2.5 microliter per kilogram (body weight) per dose
Aco Apache Ultrasound
Deviceecho for sonoporation
Treatment groups
24 Participants
are divided into 4 treatment groupsGroup A: One short sonoporationExperimental treatment 3 interventions
Group B: One long sonoporationExperimental treatment 3 interventions
Group C: two long sonoporationExperimental treatment 3 interventions
Group D: three long sonoporationExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
AE
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame
within 28 days (Cycle 1)2
MTD
To determine the maximum tolerated dose of NH002 in the 3+3 design according to assessment of dose-limiting toxicities with CTCAE v 5.0
Time frame
within 28 days (cycle 1)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Taiwan University Hospital
Lead sponsor
Trust Bio-sonics, Inc.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: