A Single-center, Prospective, Non-randomized, Open, Pilot Study Evaluating the Safety and Performance of the Extroducer® Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients with Unresectable Locally Advanced Pancreatic Cancer

Conditions

Unresectable Locally Advanced Pancreatic Cancer

Brief summary

Occurrence of Extroducer® related Serious Adverse Events within 72 hours post Extroducer® treatment infusion with Gemcitabine.

Detailed description

Occurrence of Gemcitabine related Serious Adverse Events from first Extroducer® treatment infusion with Gemcitabine until study completion., Survival rates (Overall Survival (OS) and Progression Free Survival (PFS)) at 6 months after final Extroducer® treatment infusion with Gemcitabine., Classification of tumor resectability according to NCCN resectability criteria before (baseline) and after (Visits 11-13) Extroducer® treatment infusion with Gemcitabine., Classification of tumor response according to RECIST before (baseline) and after (Visits 11-13) Extroducer® treatment infusion with Gemcitabine., Evaluation of the tumor marker CA-19-9 before (baseline) and after (Visits 9, 11-13) Extroducer® treatment infusion with Gemcitabine., Evaluation of subjects’ quality of life using the EORTC QLQ-C30 and PANC26 questionnaires before (baseline) and after (Visits 11-13) Extroducer® treatment infusion with Gemcitabine., The incidence, severity, and seriousness of Adverse Events and Device Deficiencies throughout the clinical investigation.

Related papers

No related papers found yet.

Interventions

DRUGGemcitabin Sandoz 40 mg/ml koncentrat till infusionsvätska

DRUGlösning

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Occurrence of Extroducer® related Serious Adverse Events within 72 hours post Extroducer® treatment infusion with Gemcitabine.	—

Secondary

Measure	Time frame
Occurrence of Gemcitabine related Serious Adverse Events from first Extroducer® treatment infusion with Gemcitabine until study completion., Survival rates (Overall Survival (OS) and Progression Free Survival (PFS)) at 6 months after final Extroducer® treatment infusion with Gemcitabine., Classification of tumor resectability according to NCCN resectability criteria before (baseline) and after (Visits 11-13) Extroducer® treatment infusion with Gemcitabine., Classification of tumor response according to RECIST before (baseline) and after (Visits 11-13) Extroducer® treatment infusion with Gemcitabine., Evaluation of the tumor marker CA-19-9 before (baseline) and after (Visits 9, 11-13) Extroducer® treatment infusion with Gemcitabine., Evaluation of subjects’ quality of life using the EORTC QLQ-C30 and PANC26 questionnaires before (baseline) and after (Visits 11-13) Extroducer® treatment infusion with Gemcitabine., The incidence, severity, and seriousness of Adverse Events and Device Defi	—

Measure

Time frame

Occurrence of Gemcitabine related Serious Adverse Events from first Extroducer® treatment infusion with Gemcitabine until study completion., Survival rates (Overall Survival (OS) and Progression Free Survival (PFS)) at 6 months after final Extroducer® treatment infusion with Gemcitabine., Classification of tumor resectability according to NCCN resectability criteria before (baseline) and after (Visits 11-13) Extroducer® treatment infusion with Gemcitabine., Classification of tumor response according to RECIST before (baseline) and after (Visits 11-13) Extroducer® treatment infusion with Gemcitabine., Evaluation of the tumor marker CA-19-9 before (baseline) and after (Visits 9, 11-13) Extroducer® treatment infusion with Gemcitabine., Evaluation of subjects’ quality of life using the EORTC QLQ-C30 and PANC26 questionnaires before (baseline) and after (Visits 11-13) Extroducer® treatment infusion with Gemcitabine., The incidence, severity, and seriousness of Adverse Events and Device Defi

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Outcome results

None listed