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NH002-mediated Sonoporation With Chemotherapy in Advanced Pancreatic Cancer

NCT07314385 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-01-02

No results posted yet for this study

Summary

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.

Conditions

  • Pancreatic Adenocarcinoma Metastatic
  • Liver Metastasis

Interventions

DRUG

nanoliposomal irinotecan+5-FU+leucovorin

nanoliposomal irinotecan 70 mg/m2 5-FU 2400 mg/m2 Leucovorin 400 mg/m2

DRUG

NH002 (Perflutren Lipid Microspheres) Injectable Suspension

2.5 microliter per kilogram (body weight) per dose

DEVICE

Aco Apache Ultrasound

echo for sonoporation

Sponsors & Collaborators

  • Trust Bio-sonics, Inc.

    collaborator INDUSTRY

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Taiwan

Study Locations

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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 NCT07314385 on ClinicalTrials.gov