Limited metastatic pancreatic cancer
Conditions
Brief summary
The main endpoint of the first inclusion phase is to determine safety/toxicity of IMM- 101 and SBRT administration in patients with limited metastatic pancreatic cancer., The main endpoint of the second inclusion phase is to asses efficacy of IMM-101 therapy in combination with SBRT in patients with limited metastatic pancreatic cancer.
Detailed description
Overall survival will be calculated from the start of FOLFIRINOX treatment to death (OS1)., Overall survival will be calculated from the start of IMM-101 treatment to death (OS2)., Progression free survival will be calculated from the start of IMM-101 treatment to the date of progressive disease of the primary tumour or locoregional recurrence, progression of previously treated lungs and/or liver metastasis, the occurrence of new metastases or death (PFS2)., Quality of life. Scoring procedures for the EORTC QLQ-c30 will be varied out according to the corresponding manual. Scores between baseline and week 8 will be compared by using the paired t-test for normally distributed data while the Wilcoxon signed rank test will be used for non-normally distributed data. For visualization, box plots will be generated., Radiological response rate after IMM-101 and SBRT using iRECIST criteria., Radiological response rate after IMM-101 and SBRT using RECIST criteria (version 1.1)., Safety/Toxicity according to CTCAE 5.0., Effect on circulating immune cells: pre-treatment (week 0), during treatment (week 2,4,8) and post treatment (week 26) venous blood will be monitored for the frequency and activation state of T cells, NKs, and myeloid subsets and for WT-1 and mesothelin specific T cell responses by flow cytometry and Elispot read-out; inflammatory and suppressive cytokine levels will be assessed in plasma., Tumour-specific immune and tumour marker responses. Pre- and 2x post-treatment CA19.9 and CEA levels will be assessed on blood samples.
Interventions
None listed
Sponsors
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint of the first inclusion phase is to determine safety/toxicity of IMM- 101 and SBRT administration in patients with limited metastatic pancreatic cancer., The main endpoint of the second inclusion phase is to asses efficacy of IMM-101 therapy in combination with SBRT in patients with limited metastatic pancreatic cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival will be calculated from the start of FOLFIRINOX treatment to death (OS1)., Overall survival will be calculated from the start of IMM-101 treatment to death (OS2)., Progression free survival will be calculated from the start of IMM-101 treatment to the date of progressive disease of the primary tumour or locoregional recurrence, progression of previously treated lungs and/or liver metastasis, the occurrence of new metastases or death (PFS2)., Quality of life. Scoring procedures for the EORTC QLQ-c30 will be varied out according to the corresponding manual. Scores between baseline and week 8 will be compared by using the paired t-test for normally distributed data while the Wilcoxon signed rank test will be used for non-normally distributed data. For visualization, box plots will be generated., Radiological response rate after IMM-101 and SBRT using iRECIST criteria., Radiological response rate after IMM-101 and SBRT using RECIST criteria (version 1.1)., Safety/Toxicity | — |
Countries
Netherlands
Outcome results
None listed