Ignite Creation Date:
2024-07-17 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499610
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-03
Brief Title:
Clinical Study of Irinotecan Liposome Combination Therapy for Advanced Gastric Cancer
Sponsor:
First Affiliated Hospital Xian Jiaotong University
Organization:
First Affiliated Hospital Xian Jiaotong University
Study Overview
Official Title:
Prospective Open-label Single-arm Clinical Study of Irinotecan Liposomes Combined With Cindilizumab and Lunvalatinib as Second-line Treatment for Adenocarcinoma of Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 single-arm single-center exploratory clinical study It is expected that 44 patients with advanced gastric and gastroesophageal junction adenocarcinoma with first-line treatment failure will be included to receive irinotecan liposomes combined with cindilizumab and renvalatinib The study unit is the First Affiliated Hospital of Xian Jiaotong University The study included screening period 28 days treatment period 6 cycles and follow-up period Subjects signed the informed consent and underwent baseline examination during the screening period patients meeting the exclusion criteria entered the treatment period and all subjects completed the protocol to observe safety tolerability and efficacy The same subject received only one dosing schedule during the study period The follow-up period begins after the end of the treatment period
Detailed Description:
This study is an exploratory clinical study It is expected to include 44 patients with second-line advanced gastric and gastroesophageal junction adenocarcinoma all treated with irinotecan liposome combined with cindilizumab and lunvatinib
The dosing regimen of irinotecan liplex injection was 70 mg m2 cindilizmab 200mg and valatinib 8-12mg dose determined by body weight every 3 weeks every 2 treatment cycles every 6 weeks The subject is scheduled to receive 6 cycles of treatment or develop intolerable toxicity or terminate the study for other reasons
The study included screening period within 28 days treatment period 6 cycles and follow-up period Subjects signed the informed consent and underwent baseline examination during the screening period patients meeting the exclusion criteria entered the treatment period and all subjects completed the protocol to observe safety tolerability and efficacy The same subject received only one dosing schedule during the study period The follow-up period begins after the end of the treatment period
The dosing regimen of irinotecan liplex injection was 70 mg m2 cindilizmab 200mg and valatinib 8-12mg dose determined by body weight every 3 weeks every 2 treatment cycles every 6 weeks The subject is scheduled to receive 6 cycles of treatment or develop intolerable toxicity or terminate the study for other reasons
The study included screening period within 28 days treatment period 6 cycles and follow-up period Subjects signed the informed consent and underwent baseline examination during the screening period patients meeting the exclusion criteria entered the treatment period and all subjects completed the protocol to observe safety tolerability and efficacy The same subject received only one dosing schedule during the study period The follow-up period begins after the end of the treatment period
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