Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578052
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Irinotecan Liposome in Combination With Capecitabine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Irinotecan Liposome in Combination With Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer Phase II Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
Pancreatic cancer is a group of malignant tumors mainly originated from pancreatic ductal epithelium and follicular cells with high degree of malignancy insidious onset difficult early diagnosis rapid progression short survival time and one of the malignant tumors with the worst prognosis which is known as the king of cancers In recent years the incidence rate of pancreatic cancer has been increasing both at home and abroad At present the palliative treatment of advanced pancreatic cancer is still mainly based on chemotherapy such as FOLFIRINOX regimen And after standard first-line treatment most of the patients have problems such as poor physical status no standard treatment options and limited options available
Capecitabine is a selective fluorouracil methionine salt antitumor drug belongs to the pyrimidine class of antimetabolites and is the precursor drug of 5-fluorouracil Its first-line monotherapy for pancreatic cancer is 24 effective and it is directly recommended by NCCN 2024 V20 as a second-line treatment for patients with pancreatic cancer who have failed gemcitabine therapyThe 2024 CSCO Guidelines for Pancreatic Cancer recommend the use of 5-fluorouracil 5-FU-like regimens as a second-line treatment for patients who have been treated with a gemcitabine-based regimen as first-line treatment In a clinical study exploring capecitabine in gemcitabine-treated patients with metastatic or unresectable locally advanced pancreatic cancer 42 patients received oral capecitabine 1250 mgm2 twice daily 2500 mgm2d as intermittent therapy in 3-week cycles consisting of 2 weeks of dosing followed by 1 week of withdrawal A total of 4 remissions were achieved in 42 evaluable patients for an overall remission rate of 95
Irinotecan Hydrochloride Liposome Injection the first domestic generic product developed by Shiyao Group was launched in China in September 2023 with an approved indication for use in combination with 5-FU and calcium folinate LV in patients with metastatic pancreatic cancer that has progressed after treatment with gemcitabine Liposomal irinotecan hydrochloride has been studied in a number of indications including biliary tract cancer colorectal cancer glioma gastric cancer small cell lung cancer cervical cancer breast cancer head and neck cancer esophageal cancer and neuroendocrine cancer In the bioequivalence trial of Shiyi Groups irinotecan hydrochloride liposome injection the ORR rate reached 129 the median PFS was 624 months and the median OS was 1038 months indicating similar efficacy and a similar safety profile A randomized open-label phase 3 NAPOLI 3 study and the first phase 3 trial comparing two combination chemotherapy regimens in the first-line treatment of patients with pancreatic ductal carcinoma head-to-head was designed to compare the efficacy and safety differences between the NALIRIFOX regimen irinotecan liposomal fluorouracil and calcium folinic acid in combination with oxaliplatin versus the doublet regimen gemcitabine albumin-conjugated paclitaxel in the first-line treatment of metastatic pancreatic ductal carcinoma efficacy and safety differences in the treatment of metastatic pancreatic ductal cancer The results showed that the median OS in the NALIRIFOX treatment group was 111 months while the median OS in the dual combination treatment group was 92 months HR083 95 CI 070-099 p0036
Based on the above literature research combined with the efficacy and safety advantages of irinotecan liposome chemotherapy combination regimen in patients with metastatic pancreatic cancer we propose to carry out a phase II clinical study of irinotecan liposome combined with capecitabine in the second-line treatment of advanced pancreatic cancer The aim is to explore the efficacy and safety of irinotecan liposomal chemotherapy combined with capecitabine in second-line unresectable or metastatic pancreatic cancer patients and to explore more effective clinical options for patients with pancreatic cancer that has progressed after previous treatment
Capecitabine is a selective fluorouracil methionine salt antitumor drug belongs to the pyrimidine class of antimetabolites and is the precursor drug of 5-fluorouracil Its first-line monotherapy for pancreatic cancer is 24 effective and it is directly recommended by NCCN 2024 V20 as a second-line treatment for patients with pancreatic cancer who have failed gemcitabine therapyThe 2024 CSCO Guidelines for Pancreatic Cancer recommend the use of 5-fluorouracil 5-FU-like regimens as a second-line treatment for patients who have been treated with a gemcitabine-based regimen as first-line treatment In a clinical study exploring capecitabine in gemcitabine-treated patients with metastatic or unresectable locally advanced pancreatic cancer 42 patients received oral capecitabine 1250 mgm2 twice daily 2500 mgm2d as intermittent therapy in 3-week cycles consisting of 2 weeks of dosing followed by 1 week of withdrawal A total of 4 remissions were achieved in 42 evaluable patients for an overall remission rate of 95
Irinotecan Hydrochloride Liposome Injection the first domestic generic product developed by Shiyao Group was launched in China in September 2023 with an approved indication for use in combination with 5-FU and calcium folinate LV in patients with metastatic pancreatic cancer that has progressed after treatment with gemcitabine Liposomal irinotecan hydrochloride has been studied in a number of indications including biliary tract cancer colorectal cancer glioma gastric cancer small cell lung cancer cervical cancer breast cancer head and neck cancer esophageal cancer and neuroendocrine cancer In the bioequivalence trial of Shiyi Groups irinotecan hydrochloride liposome injection the ORR rate reached 129 the median PFS was 624 months and the median OS was 1038 months indicating similar efficacy and a similar safety profile A randomized open-label phase 3 NAPOLI 3 study and the first phase 3 trial comparing two combination chemotherapy regimens in the first-line treatment of patients with pancreatic ductal carcinoma head-to-head was designed to compare the efficacy and safety differences between the NALIRIFOX regimen irinotecan liposomal fluorouracil and calcium folinic acid in combination with oxaliplatin versus the doublet regimen gemcitabine albumin-conjugated paclitaxel in the first-line treatment of metastatic pancreatic ductal carcinoma efficacy and safety differences in the treatment of metastatic pancreatic ductal cancer The results showed that the median OS in the NALIRIFOX treatment group was 111 months while the median OS in the dual combination treatment group was 92 months HR083 95 CI 070-099 p0036
Based on the above literature research combined with the efficacy and safety advantages of irinotecan liposome chemotherapy combination regimen in patients with metastatic pancreatic cancer we propose to carry out a phase II clinical study of irinotecan liposome combined with capecitabine in the second-line treatment of advanced pancreatic cancer The aim is to explore the efficacy and safety of irinotecan liposomal chemotherapy combined with capecitabine in second-line unresectable or metastatic pancreatic cancer patients and to explore more effective clinical options for patients with pancreatic cancer that has progressed after previous treatment
Detailed Description:
This study is a prospective multicenter single-arm phase II study It is expected to include 20 patients with unresectablemetastatic pancreatic cancer who have relapsed after standard treatment and they will be treated with a regimen of liposomal irinotecan combined with capecitabine The main research unit is the Shenzhen Hospital of the Chinese Academy of Medical Sciences Cancer Hospital The study includes a screening period within 28 days a treatment period an estimated 6 cycles until disease progression or intolerable toxicity occurs and a follow-up period 12 months for safety follow-up and progression-free survival PFS follow-up Participants sign an informed consent form and undergo baseline examinations during the screening period Patients who meet the inclusion and exclusion criteria enter the treatment period and all participants complete the relevant examinations stipulated by the protocol during the treatment process to observe safety tolerability and efficacy The same participant will only receive one dosing plan during the study period After the end of the treatment period the follow-up period begins
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