Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393400
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-18
Brief Title:
CHemotherapy And Stool Transplant in PDAC CHASe-PDAC
Sponsor:
John Lenehan
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
An Open-label Single-arm Phase 1 Study of the Combination of FMT and Gemcitabine With Nab-paclitaxel as First-line Therapy in Patients With Advanced Pancreatic Ductal Adenocarcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHASe-PDAC
Brief Summary:
To confirm the safety of combining oral fecal microbiota transplantation FMT with gemcitabine and nab-paclitaxel chemotherapy as first line treatment in patients with unresectable or metastatic pancreatic ductal adenocarcinoma
Detailed Description:
This is a phase 1 open-labelled non-randomized safety trial examining oral fecal microbiota transplantation FMT with healthy donor stool in combination with standard of care SOC gemcitabine and nab-paclitaxel GnP in patients with advanced unresectable and metastatic pancreatic ductal adenocarcinoma PDAC as first-line therapy A total of 20 eligible patients will be treated with study treatment The purpose of the trial is to confirm the safety of combined therapy assess clinical outcomes perform gut microbiome analysis systemic immune profiling and explore patient-related outcomes This trial will be conducted at the Verspeeten Family Cancer Centre formerly known as the London Regional Cancer Program at London Health Sciences Centre
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None