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The role of sonoporation-enhanced treatment with Gemcitabine, Nab-Paclitaxel and FOLFIRINOX in patients with inoperable pancreatic cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512176-35-00
Enrollment
60
Registered
2024-09-26
Start date
2024-09-27
Completion date
Unknown
Last updated
2024-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Brief summary

Progression free survival based on the RECIST-criteria

Detailed description

Key secondary efficacy endpoint: Overall survival., Time to treatment failure, defined as time from study day 1 to disease progression (RECIST-criteria from CT) and/or rapidly deteriorating ECOG performance status., Number of completed chemotherapy cycles before treatment failure, Changes in local disease progression using RECIST-criteria (CT), Changes in maximum tumour diameter (CT and ultrasound), Changes in disease progression using primary tumour volume (CT and ultrasound)

Interventions

DRUGIrinotecan Accord 20 mg/ml konsentrat til infusjonsvæske
DRUGoppløsning
DRUGGemkabi 38 mg/ml konsentrat til infusjonsvæske
DRUGAbraxane 5 mg/ml powder for dispersion for infusion.
DRUGOksaliplatin SUN 5 mg/ml konsentrat til infusjonsvæske

Sponsors

Helse Bergen HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression free survival based on the RECIST-criteria

Secondary

MeasureTime frame
Key secondary efficacy endpoint: Overall survival., Time to treatment failure, defined as time from study day 1 to disease progression (RECIST-criteria from CT) and/or rapidly deteriorating ECOG performance status., Number of completed chemotherapy cycles before treatment failure, Changes in local disease progression using RECIST-criteria (CT), Changes in maximum tumour diameter (CT and ultrasound), Changes in disease progression using primary tumour volume (CT and ultrasound)

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026