A national randomised multi-centre phase II/III trial using MesoPher in ABC borderline resectable pancreatic cancer (PREOPANC-6 trial)

Condition studied

ABC borderline resectable pancreatic cancer

Eligibility

Primary endpoint

Phase II Progression-free survival (PFS): defined as the time from initiation of study treatment to the first documented recurrent disease or progressive disease (PD) per RECIST 1.1, or death to any cause, whichever occurs first (exploratory endpoint), Phase III Overall survival (OS): the time from inclusion to death due to any cause.

Endpoint detail

Phase II Assessments of immune responses • Vaccine-induced responses by analysing peripheral blood mononuclear cells (PBMCs) and performing NanoString analyses • Modulation of peripheral immune cell subsets by analysing PBMCs • Predictive gene expression signatures related to therapy outcome by using nCounter NanoString analyses, Phase II Disease-free survival: defined as the first documented evidence of recurrence of disease as defined by RECIST 1.1 criteria., Phase II Patient reported quality of life using the EORTC QLQC30 and the EORTC-QLQPAN26 questionnaires., Phase II To assess safety by AEs and study intervention discontinuations due to AEs., Phase III Assessments of immune responses • Vaccine-induced responses by analysing peripheral blood mononuclear cells (PBMCs) and performing NanoString analyses •Modulation of peripheral immune cell subsets by analysing PBMCs • Predictive gene expression signatures related to therapy outcome by using nCounter NanoString analyses, Phase III Disease-free survival: defined as the first documented evidence of recurrence of disease as defined by RECIST 1.1 criteria., Pase III Event-free survival: defined as the time from randomisation to any of the following events: failure to undergo surgery, disease recurrence, or death from any cause., Phase III Patient reported quality of life using the EORTC QLQC30 and the EORTC-QLQPAN26 questionnaires., Phase III To assess safety by AEs and study intervention discontinuations due to AEs., Phase III: Progression-free survival (PFS): defined as the time from initiation of study treatment to the first documented recurrent disease or progressive disease (PD) per RECIST 1.1, or death to any cause, whichever occurs first.