Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531278
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Adebelimab Combined With Irinotecan Liposomal Injection Oxaliplatin Fluorouracil and Calcium Folinate Are Used in the First-line Treatment of Pancreatic Cancer Liver Metastasis Efficacy and Safety
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Adebelimab Combined With Irinotecan Liposomal Injection Oxaliplatin Fluorouracil and Calcium Folinate Are Used in the First-line Treatment of Pancreatic Cancer Liver Metastasis Efficacy and Safety
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Evaluation of adebelimab in combination with irinotecan liposomes oxaliplatin fluorouracil efficacy and safety of leucovorin in the first-line treatment of advanced metastatic pancreatic cancer
2 Construct the model of immunotherapy combined with chemotherapy for the treatment of pancreatic cancer liver metastasis
2 Construct the model of immunotherapy combined with chemotherapy for the treatment of pancreatic cancer liver metastasis
Detailed Description:
Pancreatic cancer is a cancer of the digestive system with a very high degree of malignancy and a very poor prognosis In recent years morbidity and death The rate shows a clear upward trend at home and abroad Global cancer statistics in 2020 show that there are new pancreas cases worldwide each year There are about 495000 cases of adenocarcinoma and about 466000 deaths from pancreatic cancer each year Statistical tables for 2020 In the United States there are about 57600 new cases of pancreatic cancer every year and about 47050 deaths due to pancreatic cancer each year Data from pancreatic cancer collected by the National Cancer Center of China in 2019 show that the incidence of pancreatic cancer in Chinese is692 per 100000 with new cases accounting for about 431 of all malignant tumors The case fatality rate is 616 per 100000 and deaths per year Cases account for about 378 of all malignancies The specific etiology and pathogenesis of pancreatic cancer are unclear and most 85 It is an adenocarcinoma originating from the ductal epithelium Early symptoms are atypical and most patients are diagnosed locally advanced or out Now distant metastasis In the past decade the first-line treatment regimen for pancreatic cancer has been AG FOLFIRINOX GS as the commonly used chemotherapy regimens and the median OS was 85 months 111 months and 101 months respectively First-line treatment for pancreatic cancer still needs to be explored The advent of plastid Iriconia has changed the landscape of first-line treatments and the NAPOLI-3 study compared NALIRINOX liposome irinotecan oxaliplatin fluorouracil leucovorin and AG regimens in the first-line treatment of metastatic pancreatic cancer and safety with a median follow-up of 161 months showed that the median OS of NALIRINOX versus AG was respectively 111 versus 92 months HR 083 95 CI 070-099 p0036 and the median PFS was 74 vs 56 respectively months HR 069 058-083 p00001 the ORR was 42 and 36 respectively Based on this research The FDA approved liposomal irinotecan in combination with oxaliplatin fluorouracil and leucovorin for the first-line treatment of metastatic pancreas Indications for adenocarcinoma
Jiangsu Hengrui Pharmaceutical Co Ltd developed irinotecan hydrochloride liposome injection HR070803 has both protection Protective long-term cyclic and passively targeted HR070803 combination with 5-FULV for second-line treatment of locally advanced or metastatic pancreas after failure of gemcitabine therapy Adenocarcinoma Significantly prolonged the subjects OS compared to placebo in combination with 5-FULV with a clinically meaningful difference Significantly lower risk of death In addition HR070803 in combination with 5-FULV may also prolong the subjects PFS and TTF and improve ORR and CA19-9 response rates At the same time HR070803 combined with 5-FULV in advanced pancreas The type of AE observed in the treatment of adenocarcinoma is consistent with that of regular irinotecan and there are gastrointestinal reactions hematotoxic It is less sexual well tolerated and safe and controllable
Based on the above evidence this study explored the efficacy and safety of adebelimab irinotecan liposome oxaliplatin fluorouracil and leucovorin in the first-line treatment of advanced metastatic pancreatic cancer
Jiangsu Hengrui Pharmaceutical Co Ltd developed irinotecan hydrochloride liposome injection HR070803 has both protection Protective long-term cyclic and passively targeted HR070803 combination with 5-FULV for second-line treatment of locally advanced or metastatic pancreas after failure of gemcitabine therapy Adenocarcinoma Significantly prolonged the subjects OS compared to placebo in combination with 5-FULV with a clinically meaningful difference Significantly lower risk of death In addition HR070803 in combination with 5-FULV may also prolong the subjects PFS and TTF and improve ORR and CA19-9 response rates At the same time HR070803 combined with 5-FULV in advanced pancreas The type of AE observed in the treatment of adenocarcinoma is consistent with that of regular irinotecan and there are gastrointestinal reactions hematotoxic It is less sexual well tolerated and safe and controllable
Based on the above evidence this study explored the efficacy and safety of adebelimab irinotecan liposome oxaliplatin fluorouracil and leucovorin in the first-line treatment of advanced metastatic pancreatic cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None