NH002-mediated Sonoporation With Chemotherapy in Advanced Pancreatic Cancer

Sponsor
National Taiwan University Hospital
Study ID
NCT07314385
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Liver Metastasis
  • Pancreatic Adenocarcinoma Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • nanoliposomal irinotecan+5-FU+leucovorin — DRUG
    nanoliposomal irinotecan 70 mg/m2 5-FU 2400 mg/m2 Leucovorin 400 mg/m2
  • NH002 (Perflutren Lipid Microspheres) Injectable Suspension — DRUG
    2.5 microliter per kilogram (body weight) per dose
  • Aco Apache Ultrasound — DEVICE
    echo for sonoporation

Study Details

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.

Key Dates

Start date
Jan 1, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: One short sonoporation
    one short course of sonoporation (on Cycle 1 Day 1) * NH002: 1 dose * sonoporation: 1 course (10 min)
  • Experimental: One long sonoporation
    one long course of sonoporation (Cycle 1, Day 1) * NH002: 2 doses * sonoporation: 2 courses (20 min)
  • Experimental: two long sonoporation
    two long courses of sonoporation (Cycle 1, Day 1 \& 2) * NH002: 2 doses, D1 \& D2 * sonoporation: 2 courses (20 min), D1 \& D2
  • Experimental: three long sonoporation
    three long courses of sonoporation (Cycle 1, Day 1, 2 \& 3) * NH002: 2 doses; D1, D2 \& D3 * sonoporation: 2 courses (20 min); D1, D2 \& D3

Primary Outcome Measure

AE [ Time Frame: within 28 days (Cycle 1) ]

Central Contacts

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