Ignite Creation Date:
2024-05-06 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03563326
Status:
UNKNOWN
Last Update Posted:
2018-09-17
First Post:
2018-05-05
Brief Title:
Intraperitoneal Infusion of EpCAM CAR-T Cell in Advanced Gastric Cancer With Peritoneal Metastasis WCH-GC-CART
Sponsor:
Jian-Kun Hu
Organization:
West China Hospital
Study Overview
Official Title:
Clinical Trial of Intraperitoneal CAR-T Cells Infusion for the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
RECRUITING
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:
To investigate the safety and efficacy of intraperitoneal infusion of EpCAM CAR-T cell in advanced gastric cancer with peritoneal metastasis by a prospective nonrandomized controlled trial
Detailed Description:
Chimeric antigen receptor modified T CAR-T cells have the capability in targeting and recognizing tumor antigen and can specifically recognize bind and kill tumor cells with positive antigen Through local drug delivery CAR-T cells have successfully achieved remarkable effect to treat solid tumors Gastric cancer is one of the most frequent malignant tumors with high mortality especially in China Peritoneal metastasis is one of the common routes of metastasis Once peritoneal metastasis occurred patients should be categorized as clinical pathological stage IV with extremely poor prognosis and the effect of routine treatments would be unsatisfactory Epithelial cell adhesion molecule EpCAM is highly expressed in gastric cancer cells and closely associated with the poor prognosis of patients In our previous pre-clinical research researches the investigators have obtained CAR-T cells targeting EpCAM EpCAM CAR-T and finished the preparations of cells which could be used in clinical practice Based on our previous works the investigators aim to investigate the safety and efficacy of peritoneal infusion of EpCAM CAR-T cell in advanced gastric cancer with peritoneal metastasis by a prospective nonrandomized controlled trial The results of this clinical trial are expected to provide the new treatment strategy for gastric cancer patients with peritoneal metastasis
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