Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-03 @ 8:20 AM
Study NCT ID:
NCT04617457
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2020-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy and Surgical Resection in Patients With Hepatic Oligometastatic Adenocarcinoma of the Pancreas
Sponsor:
University of Cologne
Organization:
Study Overview
Official Title:
Open-label, Single Arm Phase II Trial Investigating the Efficacy, Safety and Quality of Life of Neoadjuvant Chemotherapy With Liposomal Irinotecan Combined With Oxaliplatin and 5-Fluorouracil/Folinic Acid Followed by Curative Surgical Resection in Patients With Hepatic Oligometastatic Adenocarcinoma of the Pancreas
Status:
RECRUITING
Status Verified Date:
2024-01
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:
HOLIPANC
Brief Summary:
This is an interventional, open-label, non-randomised, multicentre, single-arm phase II clinical trial.
Eligible patients with hepatic oligometastatic adenocarcinoma of the pancreas will receive neoadjuvant combination chemotherapy (liposomal irinotecan, oxaliplatin, 5-fluouracil, folinic acid (NAPOX)) in cycles of 14 days. Patients with tumour response or stable disease and a resectable primary tumour after the first 4 cycles will undergo explorative laparotomy and synchronous resection of the tumour and hepatic metastases, if feasible; these patients may receive 4 more cycles of neoadjuvant chemotherapy 2-4 weeks after the explorative laparotomy if the surgeon rated the primary tumour as non-resectable during the explorative laparotomy.
Eligible patients with hepatic oligometastatic adenocarcinoma of the pancreas will receive neoadjuvant combination chemotherapy (liposomal irinotecan, oxaliplatin, 5-fluouracil, folinic acid (NAPOX)) in cycles of 14 days. Patients with tumour response or stable disease and a resectable primary tumour after the first 4 cycles will undergo explorative laparotomy and synchronous resection of the tumour and hepatic metastases, if feasible; these patients may receive 4 more cycles of neoadjuvant chemotherapy 2-4 weeks after the explorative laparotomy if the surgeon rated the primary tumour as non-resectable during the explorative laparotomy.
Detailed Description:
This is an interventional, open-label, non-randomised, multicentre, single-arm phase II clinical trial.
Eligible patients with hepatic oligometastatic adenocarcinoma of the pancreas will receive neoadjuvant NAPOX chemotherapy in cycles of 14 days.
In patients with progressive disease during or after the first 4 cycles, neoadjuvant chemotherapy will be permanently discontinued. Patients with tumour response or stable disease after the first 4 cycles according to RECIST v1.1 but a non-resectable primary tumour according to the evaluation of an interdisciplinary tumour board will receive 4 more cycles of neoadjuvant chemotherapy. Patients with tumour response or stable disease and a resectable primary tumour after the first 4 cycles will undergo explorative laparotomy and synchronous resection of the tumour and hepatic metastases, if feasible; these patients may receive 4 more cycles of neoadjuvant chemotherapy 2-4 weeks after the explorative laparotomy if the surgeon rated the primary tumour as non-resectable during the explorative laparotomy.
All patients who receive a total of 8 cycles and who then have tumour response or stable disease according to RECIST v1.1 will undergo exploratory laparotomy surgery and synchronous resection of the tumour and hepatic metastases, if feasible according to the surgeon, 2-6 weeks after the last investigational medicinal product (IMP) treatment.
The primary endpoint of the clinical trial is overall survival of patients with an R0/R1 resection after neoadjuvant chemotherapy.
The IMP treatment will be discontinued if tumour progression or inacceptable toxicity occurs or other termination criteria apply.
Adjuvant treatment will not be part of the trial treatment and may be given at the investigator's discretion in accordance with the Onkopedia guideline for pancreatic cancer.
Tumour, stool and blood samples will be collected before start and during the clinical trial for translational research if the patient gives his/her consent to participating in the translational research programme.
Eligible patients with hepatic oligometastatic adenocarcinoma of the pancreas will receive neoadjuvant NAPOX chemotherapy in cycles of 14 days.
In patients with progressive disease during or after the first 4 cycles, neoadjuvant chemotherapy will be permanently discontinued. Patients with tumour response or stable disease after the first 4 cycles according to RECIST v1.1 but a non-resectable primary tumour according to the evaluation of an interdisciplinary tumour board will receive 4 more cycles of neoadjuvant chemotherapy. Patients with tumour response or stable disease and a resectable primary tumour after the first 4 cycles will undergo explorative laparotomy and synchronous resection of the tumour and hepatic metastases, if feasible; these patients may receive 4 more cycles of neoadjuvant chemotherapy 2-4 weeks after the explorative laparotomy if the surgeon rated the primary tumour as non-resectable during the explorative laparotomy.
All patients who receive a total of 8 cycles and who then have tumour response or stable disease according to RECIST v1.1 will undergo exploratory laparotomy surgery and synchronous resection of the tumour and hepatic metastases, if feasible according to the surgeon, 2-6 weeks after the last investigational medicinal product (IMP) treatment.
The primary endpoint of the clinical trial is overall survival of patients with an R0/R1 resection after neoadjuvant chemotherapy.
The IMP treatment will be discontinued if tumour progression or inacceptable toxicity occurs or other termination criteria apply.
Adjuvant treatment will not be part of the trial treatment and may be given at the investigator's discretion in accordance with the Onkopedia guideline for pancreatic cancer.
Tumour, stool and blood samples will be collected before start and during the clinical trial for translational research if the patient gives his/her consent to participating in the translational research programme.
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?:
False
Is an FDA AA801 Violation?: