Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-27 @ 4:48 PM
Study NCT ID:
NCT05679050
Status:
UNKNOWN
Last Update Posted:
2023-01-10
First Post:
2022-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study on Sequential AG and FOLFIRINOX as Neoadjuvant Therapy in Patients With Resectable Pancreatic Cancer
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Study Overview
Official Title:
Single-arm, Single-centered, Open-label Phase II Study on Sequential AG Regimen and FOLFIRINOX Regimen as Neoadjuvant Therapy in Patients With Resectable Pancreatic Cancer
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Based on the safety and benefit of neoadjuvant therapy for patients with pancreatic cancer in the available evidence, as well as the principle of sequential chemotherapy with different regimens and the existing preliminary investigation , the aim of this study was to further explore the efficacy and safety of neoadjuvant therapy with AG regimen followed by FOLFIRINOX regimen in patients with resectable pancreatic cancer, and to assess the impact of neoadjuvant therapy on the health-related quality of life of patients, in order to bring new treatment options for neoadjuvant therapy of pancreatic cancer.
Detailed Description:
Pancreatic cancer is known as the king of cancer and is one of the malignant tumors with a very high mortality rate in the digestive system, which is characterized by a high degree of malignancy and a poor prognosis. The current standard of care is surgical resection followed by adjuvant therapy. However, patients treated with standard surgery had a 2-year median overall survival of approximately 40%. Neoadjuvant therapy can reduce the tumor to a certain extent and downstage the tumor, so as to achieve more R0 resection, reduce the postoperative recurrence rate and prolong survival.
SWOG S1505 published by ASCO in 2020 demonstrated adequate safety and high resectability rates for perioperative chemotherapy. The study concluded that perioperative chemotherapy has adequate safety and a high resectability rate. However, neither regimen in this study demonstrated an improvement in OS compared with prior standard therapies. Neoadjuvant treatment of pancreatic cancer therefore remains a long way to go.
Recent results from the NEONAX perioperative randomized phase II study for pancreatic cancer presented at the ASCO meeting in 2022 confirmed the benefit of neoadjuvant therapy and demonstrated the OS benefit brought about by neoadjuvant therapy.
Neoadjuvant regimens require regimens with good tumor shrinkage and high response rate, and there is no standard regimen for neoadjuvant therapy of pancreatic cancer, often referring to regimens with high response rate for advanced treatment. However, due to the high malignancy and disease particularity of pancreatic cancer, there is no advanced treatment regimen with high response rate. The mFOLFIRINOX (5-fluorouracil, irinotecan, oxaliplatin) and AG regimens (gemcitabine combined with nab-paclitaxel) are commonly used regimens in clinical practice. Therapeutic options for pancreatic cancer are limited, therefore, different combinations and application sequences of existing regimens are one of the directions explored in clinical research.
In summary, based on the safety and benefit of neoadjuvant therapy for patients with pancreatic cancer in the available evidence, as well as the principle of sequential chemotherapy with different regimens and the existing preliminary study exploration, the aim of this study was to further explore the efficacy and safety of neoadjuvant therapy with AG regimen followed by FOLFIRINOX regimen in patients with resectable pancreatic cancer, and to assess the impact of neoadjuvant therapy on the health-related quality of life of patients, in order to bring new treatment options for neoadjuvant therapy of pancreatic cancer.
SWOG S1505 published by ASCO in 2020 demonstrated adequate safety and high resectability rates for perioperative chemotherapy. The study concluded that perioperative chemotherapy has adequate safety and a high resectability rate. However, neither regimen in this study demonstrated an improvement in OS compared with prior standard therapies. Neoadjuvant treatment of pancreatic cancer therefore remains a long way to go.
Recent results from the NEONAX perioperative randomized phase II study for pancreatic cancer presented at the ASCO meeting in 2022 confirmed the benefit of neoadjuvant therapy and demonstrated the OS benefit brought about by neoadjuvant therapy.
Neoadjuvant regimens require regimens with good tumor shrinkage and high response rate, and there is no standard regimen for neoadjuvant therapy of pancreatic cancer, often referring to regimens with high response rate for advanced treatment. However, due to the high malignancy and disease particularity of pancreatic cancer, there is no advanced treatment regimen with high response rate. The mFOLFIRINOX (5-fluorouracil, irinotecan, oxaliplatin) and AG regimens (gemcitabine combined with nab-paclitaxel) are commonly used regimens in clinical practice. Therapeutic options for pancreatic cancer are limited, therefore, different combinations and application sequences of existing regimens are one of the directions explored in clinical research.
In summary, based on the safety and benefit of neoadjuvant therapy for patients with pancreatic cancer in the available evidence, as well as the principle of sequential chemotherapy with different regimens and the existing preliminary study exploration, the aim of this study was to further explore the efficacy and safety of neoadjuvant therapy with AG regimen followed by FOLFIRINOX regimen in patients with resectable pancreatic cancer, and to assess the impact of neoadjuvant therapy on the health-related quality of life of patients, in order to bring new treatment options for neoadjuvant therapy of pancreatic cancer.
Study Oversight
Has Oversight DMC:
False
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?:
True
Is an FDA AA801 Violation?: