Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:30 AM
Study NCT ID:
NCT07340151
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-14
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resection/Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
Study Overview
Official Title:
Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma (PHOLIPANC) Following Pre-operative Liposomal Irinotecan Combined With Oxaliplatin and 5-Fluoracil/Folinic Acid (NALIRIFOX): A Phase II Open-Label Single Arm Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
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:
PHOLIPANC
Brief Summary:
This is a clinical trial that tests a surgical treatment. Everyone in the study will get the same treatment, and there is no comparison or placebo group.
Patients can join the study if they have pancreatic cancer that has spread to only a few spots in the liver or lungs. They must be receiving a type of chemotherapy called NALIRIFOX before surgery (this is called neoadjuvant chemotherapy).
If the cancer gets worse during or after the first 4 cycles of chemotherapy, the patient will be removed from the study.
If the cancer stays the same or gets smaller after the first 4 cycles, doctors will check if the main tumor can be removed with surgery. If the tumor cannot be removed, the patient will get 4 more cycles of chemotherapy as standard of care.
If the main tumor can be removed, the patient will have surgery 2-6 weeks after finishing chemotherapy. During surgery, doctors will try to remove both the main tumor and the small tumors in the liver or lungs. If, during surgery, the doctor finds that the main tumor actually cannot be removed, the patient may receive 4 more cycles of chemotherapy starting 2-4 weeks after surgery.
Patients can join the study if they have pancreatic cancer that has spread to only a few spots in the liver or lungs. They must be receiving a type of chemotherapy called NALIRIFOX before surgery (this is called neoadjuvant chemotherapy).
If the cancer gets worse during or after the first 4 cycles of chemotherapy, the patient will be removed from the study.
If the cancer stays the same or gets smaller after the first 4 cycles, doctors will check if the main tumor can be removed with surgery. If the tumor cannot be removed, the patient will get 4 more cycles of chemotherapy as standard of care.
If the main tumor can be removed, the patient will have surgery 2-6 weeks after finishing chemotherapy. During surgery, doctors will try to remove both the main tumor and the small tumors in the liver or lungs. If, during surgery, the doctor finds that the main tumor actually cannot be removed, the patient may receive 4 more cycles of chemotherapy starting 2-4 weeks after surgery.
Detailed Description:
This is an interventional, open-label, non-randomized, single-arm clinical trial with 2 cohorts. Patients who have hepatic or pulmonary oligometastatic adenocarcinoma of the pancreas and who receive neoadjuvant Liposomal Irinotecan Combined with Oxaliplatin and 5-Fluoracil/Folinic Acid (NALIRIFOX) chemotherapy pre-operatively are eligible. In patients with progressive disease during or after the first four cycles, patients will become ineligible. Patients with tumor response or stable disease after the first 4 cycles but a non-resectable primary tumor according to the evaluation of an interdisciplinary tumor board will receive 4 more cycles of neoadjuvant chemotherapy as per standard of care. Patients with a technically resectable primary tumor and tumor response or stable disease of their metastatic disease according to the evaluation of an interdisciplinary tumor board after the first 4 cycles will undergo exploratory laparotomy and synchronous or staged resection of the primary tumor and the hepatic or pulmonary metastases by using the standard of care surgical techniques 2-6 weeks after the last neoadjuvant chemotherapy. If the primary tumor is deemed unresectable by the surgeon during exploratory laparotomy, these patients may receive 4 more cycles of adjuvant chemotherapy as per standard of care 2-4 weeks after the exploratory laparotomy.
Study Oversight
Has Oversight DMC:
True
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?: