Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06349967
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-31
Brief Title:
Nab-paclitaxel Combined With Cadonilimab AK104 for the Second-line Treatment of Advanced Gastric Cancer
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
Nab-paclitaxel Combined With Cadonilimab AK104 for the Second-line Treatment of Advanced Gastric Cancer A Prospective Multicenter Single-arm Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
Currently standard treatment options for gastric cancer failed to first-line treatment include monotherapy with paclitaxelirinotecandocetaxelalbumin paclitaxel or paclitaxel combined with ramucirumab However the efficacy of these regimens is still far from satisfactory The aim of the study is to evaluate the efficacy and safety of nab-paclitaxel combined with cadonilimab for the second-line treatment of advanced gastric cancer
Detailed Description:
This trial is a prospective multicenter single arm phase II clinical study It is divided into three stages screening period treatment period and follow-up period The main research objective of this study is to evaluate the objective response rate ORR of albumin paclitaxel combined with kandelizumab AK104 in second-line treatment of gastric cancer with failed first-line fluorouracilplatinum combination immunotherapy Secondary study objective To evaluate the disease control rate DCR progression free survival PFS overall survival OS safety tolerability and impact on patient quality of life QoL of albumin paclitaxel combined with candelizumab AK104 in second-line treatment of gastric cancer with failed first-line fluorouracilplatinum immunotherapy
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