NH002-mediated Sonoporation With Chemotherapy in Advanced Pancreatic Cancer
A Phase I Study of NH002-mediated Sonoporation With Nanoliposomal Irinotecan, Leucovorin, and 5-Fluorouracil in Pancreatic Ductal Adenocarcinoma Patients With Liver Metastasis
2 other identifiers
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2026
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedFirst Posted
Study publicly available on registry
January 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
January 2, 2026
December 1, 2025
2 years
December 1, 2025
December 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
AE
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
within 28 days (Cycle 1)
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
within 28 days (cycle 1)
Study Arms (4)
One short sonoporation
EXPERIMENTALone short course of sonoporation (on Cycle 1 Day 1) * NH002: 1 dose * sonoporation: 1 course (10 min)
One long sonoporation
EXPERIMENTALone long course of sonoporation (Cycle 1, Day 1) * NH002: 2 doses * sonoporation: 2 courses (20 min)
two long sonoporation
EXPERIMENTALtwo long courses of sonoporation (Cycle 1, Day 1 \& 2) * NH002: 2 doses, D1 \& D2 * sonoporation: 2 courses (20 min), D1 \& D2
three long sonoporation
EXPERIMENTALthree long courses of sonoporation (Cycle 1, Day 1, 2 \& 3) * NH002: 2 doses; D1, D2 \& D3 * sonoporation: 2 courses (20 min); D1, D2 \& D3
Interventions
2.5 microliter per kilogram (body weight) per dose
echo for sonoporation
nanoliposomal irinotecan 70 mg/m2 5-FU 2400 mg/m2 Leucovorin 400 mg/m2
Eligibility Criteria
You may qualify if:
- 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
- Two or more liver metastatic lesions; of them, at least one lesion with the longest diameter (measured on computed tomography \[CT\] or Magnetic resonance imaging \[MRI\]) at least 1 cm and not more than 5 cm as well as a depth not more than 7 cm from the skin to the lesion center, and considered feasible for sonoporation by the investigator
- \- Note: The number of liver metastatic lesions with the longest diameter at least 1 cm should be no more than 10.
- Has failed frontline gemcitabine-based chemotherapy and is prepared for an application of NHI-reimbursed nal-IRI, LV, and 5-FU treatment
- Has not received previous radiotherapy, local therapy (e.g., radiofrequency ablation, irreversible electroporation, etc.), or cell therapy (autologous or allogenic) for PDAC
- Has recovered from all treatment-related toxicities or resolved to no greater than grade 1, based on common terminology criteria for adverse events (CTCAE) v.5.0, before enrollment
- With an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- With adequate hematology function at screening, defined as:
- White blood cell (WBC) at least 3,500/mm3
- Absolute neutrophil count (ANC) at least 1,500/mm3
- Hemoglobin at least 10.0 g/dL
- Platelet at least 100,000/mm3
- +11 more criteria
You may not qualify if:
- 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
- Clinically significant co-morbid medical conditions, including cardiovascular disease, such as:
- Myocardial infarction within 180 days before screening
- Uncontrollable angina pectoris within 180 days before screening
- New York Heart Association (NYHA) Class III or IV congestive heart failure
- Uncontrollable hypertension despite appropriate treatment (e.g., systolic blood pressure at least 150 mmHg or diastolic blood pressure at least 90 mmHg lasting 24 hours or more)
- Arrhythmia requiring treatment
- Prior organ allograft or allogeneic bone marrow transplantation
- Received immunosuppressants within 28 days before screening or have received systemic steroid of equivalent dosage higher than prednisolone 30 mg/day for more than 7 days within 14 days prior to Cycle 1 Day 1
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
- Moderate or severe ascites, pleural effusion, or pericardial effusion requiring treatment
- Central nervous system metastasis
- Prior or concurrent malignancy other than PDAC within the last 3 years, except for carcinoma in situ of the cervix or basal type skin cancer
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Taiwan University Hospitallead
- Trust Bio-sonics, Inc.collaborator
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
Related Publications (4)
Han F, Wang Y, Dong X, Lin Q, Wang Y, Gao W, Yun M, Li Y, Gao S, Huang H, Li N, Luo T, Luo X, Qiu M, Zhang D, Yan K, Li A, Liu Z. Clinical sonochemotherapy of inoperable pancreatic cancer using diagnostic ultrasound and microbubbles: a multicentre, open-label, randomised, controlled trial. Eur Radiol. 2024 Mar;34(3):1481-1492. doi: 10.1007/s00330-023-10210-4. Epub 2023 Oct 5.
PMID: 37796294BACKGROUNDDimcevski G, Kotopoulis S, Bjanes T, Hoem D, Schjott J, Gjertsen BT, Biermann M, Molven A, Sorbye H, McCormack E, Postema M, Gilja OH. A human clinical trial using ultrasound and microbubbles to enhance gemcitabine treatment of inoperable pancreatic cancer. J Control Release. 2016 Dec 10;243:172-181. doi: 10.1016/j.jconrel.2016.10.007. Epub 2016 Oct 12.
PMID: 27744037BACKGROUNDLin CY, Li JR, Tseng HC, Wu MF, Lin WL. Enhancement of focused ultrasound with microbubbles on the treatments of anticancer nanodrug in mouse tumors. Nanomedicine. 2012 Aug;8(6):900-7. doi: 10.1016/j.nano.2011.10.005. Epub 2011 Oct 25.
PMID: 22033084BACKGROUNDWang-Gillam A, Li CP, Bodoky G, Dean A, Shan YS, Jameson G, Macarulla T, Lee KH, Cunningham D, Blanc JF, Hubner RA, Chiu CF, Schwartsmann G, Siveke JT, Braiteh F, Moyo V, Belanger B, Dhindsa N, Bayever E, Von Hoff DD, Chen LT; NAPOLI-1 Study Group. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016 Feb 6;387(10018):545-557. doi: 10.1016/S0140-6736(15)00986-1. Epub 2015 Nov 29.
PMID: 26615328BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2025
First Posted
January 2, 2026
Study Start
January 1, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
January 2, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share