Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485739
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-27
Brief Title:
Irinotecan Liposomes for the Treatment of Neuroendocrine Carcinoma
Sponsor:
First Affiliated Hospital Xian Jiaotong University
Organization:
First Affiliated Hospital Xian Jiaotong University
Study Overview
Official Title:
The Efficacy and Safety of Irinotecan Liposomes Combined With CisplatinCarboplatin for Gastrointestinal Pancreatic Neuroendocrine Carcinoma a Real-world Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
This study is a real-world clinical study It is expected to include 20 patients with first-line and second-line gastrointestinal pancreatic neuroendocrine carcinoma who will be treated with irinotecan liposomes combined with cisplatin or carboplatin regimen The research unit is the First Affiliated Hospital of Xian Jiaotong University The study includes a screening period within 28 days a treatment period planned for 6 cycles and a follow-up period safety follow-up and PFS follow-up The subjects signed an informed consent form and underwent baseline examination during the screening period Patients who met the inclusion and exclusion criteria entered the treatment period All subjects completed the relevant examinations specified in the protocol during the treatment process to observe safety tolerance and efficacy The same subject only received one dosing plan during the study period After the treatment period ends enter the follow-up period
Detailed Description:
Neuroendocrine tumors NENs are a type of tumor originating from stem cells and possessing neuroendocrine markers that can produce bioactive amines andor peptide hormones Due to their heterogeneity and inertness they have been defined as carcinoids Due to differences in origin pathological grading and treatment methods NEN has different clinical manifestations and prognosis Although NEN still meets the definition of rare disease its incidence rate has increased significantly worldwide in the past decades In the United States the incidence rate of NEN in 2012 was 698100000 about seven times the incidence rate reported in 1973 109100000 Among them gastrointestinal and pancreatic neuroendocrine tumors GEP NENs are the most common type of NEN accounting for 675 of all NEN cases They mainly occur in the digestive tract or pancreas and can produce amine substances and peptide hormones such as glucagon insulin gastrin or adrenocorticotropic hormone ACTH
We analyzed the data of ordinary irinotecan in first-line and second-line treatment of GEP-NEC and found that a prospective Phase II clinical study included 66 patients with advanced GEP-NEC The results showed that the efficacy of the first line treatment using EP and IP regimens was equivalent with an effective rate of over 40 However the efficacy of the second-line FOLFOX and FOLFIRI regimens is not ideal Studies by HENTIC et al have shown that the response rate of GEP-NEC to the FOLFIRI regimen is 31 but the PFS is only 4 months DU et al also found that the median PFS of the FOLFIRI regimen was only 65 months in 11 patients with gastrointestinal NEC The current research results on the FOLFOX regimen are similar If there are studies showing that FOLFOX is used as a second-line regimen to treat 12 patients with advanced GEP-NEC the median PFS is 45 months HEETFELD et al observed the efficacy of the FOLFIRIFOLFOX regimen in GEP-NEC patients on the second or third line and the results also showed a median PFS of 30 months and 25 months for the second and third line groups respectively Overall the second-line treatment regimens recommended by the NCCN guidelines have not shown ideal efficacy and PFS in GEP-NEC
Based on the literature review above and the birth of independently developed irinotecan liposomes by Shiyao we plan to conduct a real-world study on the combination of irinotecan liposomes and platinum based treatment of gastrointestinal neuroendocrine carcinoma The aim is to explore the efficacy and safety of a combination of irinotecan liposomes and platinum based chemotherapy regimen in first-line and second-line patients with gastrointestinal neuroendocrine carcinoma providing better clinical evidence of efficacy and safety
We analyzed the data of ordinary irinotecan in first-line and second-line treatment of GEP-NEC and found that a prospective Phase II clinical study included 66 patients with advanced GEP-NEC The results showed that the efficacy of the first line treatment using EP and IP regimens was equivalent with an effective rate of over 40 However the efficacy of the second-line FOLFOX and FOLFIRI regimens is not ideal Studies by HENTIC et al have shown that the response rate of GEP-NEC to the FOLFIRI regimen is 31 but the PFS is only 4 months DU et al also found that the median PFS of the FOLFIRI regimen was only 65 months in 11 patients with gastrointestinal NEC The current research results on the FOLFOX regimen are similar If there are studies showing that FOLFOX is used as a second-line regimen to treat 12 patients with advanced GEP-NEC the median PFS is 45 months HEETFELD et al observed the efficacy of the FOLFIRIFOLFOX regimen in GEP-NEC patients on the second or third line and the results also showed a median PFS of 30 months and 25 months for the second and third line groups respectively Overall the second-line treatment regimens recommended by the NCCN guidelines have not shown ideal efficacy and PFS in GEP-NEC
Based on the literature review above and the birth of independently developed irinotecan liposomes by Shiyao we plan to conduct a real-world study on the combination of irinotecan liposomes and platinum based treatment of gastrointestinal neuroendocrine carcinoma The aim is to explore the efficacy and safety of a combination of irinotecan liposomes and platinum based chemotherapy regimen in first-line and second-line patients with gastrointestinal neuroendocrine carcinoma providing better clinical evidence of efficacy and safety
Study Oversight
Has Oversight DMC:
None
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?:
None