Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06094140
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-08-07
Brief Title:
NEO-adjuvant Chemo-immunotherapy in Pancreatic Cancer
Sponsor:
Australasian Gastro-Intestinal Trials Group
Organization:
Australasian Gastro-Intestinal Trials Group
Study Overview
Official Title:
NEO-adjuvant Chemo-Immunotherapy in Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2023-10
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:
NEO-IMPACT
Brief Summary:
To determine the safety and tolerability of adding durvalumab to mFOLFIRINOX prior to surgery in patients with resectable or borderline resectable pancreatic adenocarcinoma
Detailed Description:
Despite curative surgery pancreatic cancer patients have five-year survival rates of 20 Adjuvant chemotherapy has improved survival in resected pancreatic cancer patients but only 10-15 are suitable for surgery and 30 of the resected pancreatic cancer patients miss out on adjuvant chemotherapy due to postoperative complications
Neoadjuvant chemotherapy has improved the resection rates in the patients with non-metastatic pancreatic cancer There is a growing interest to combine chemotherapy with checkpoint inhibitors to improve disease control in the early stage of pancreas cancer The investigators propose a pilot study to evaluate the feasibility and safety of combining modified FOLFIRINOX mFOLFIRINOX with durvalumab MEDI4736 in patients with resectable or borderline resectable pancreatic adenocarcinoma
Neoadjuvant chemotherapy has improved the resection rates in the patients with non-metastatic pancreatic cancer There is a growing interest to combine chemotherapy with checkpoint inhibitors to improve disease control in the early stage of pancreas cancer The investigators propose a pilot study to evaluate the feasibility and safety of combining modified FOLFIRINOX mFOLFIRINOX with durvalumab MEDI4736 in patients with resectable or borderline resectable pancreatic adenocarcinoma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None