NH002-mediated Sonoporation With Chemotherapy in Advanced Pancreatic Cancer (NCT07314385) | Clinical Trial Compass
Not Yet RecruitingPhase 1
NH002-mediated Sonoporation With Chemotherapy in Advanced Pancreatic Cancer
Taiwan24 participantsStarted 2026-01-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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
✓. 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
Exclusion criteria
✕. 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
✕. Clinically significant co-morbid medical conditions, including cardiovascular disease, such as:
✕. 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