Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-03-10 @ 11:28 PM
Study NCT ID:
NCT06349967
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nab-paclitaxel Combined With Cadonilimab (AK104) for the Second-line Treatment of Advanced Gastric Cancer
Sponsor:
West China Hospital
Organization:
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 paclitaxel/irinotecan/docetaxel/albumin 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 fluorouracil/platinum 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 fluorouracil/platinum 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?: