Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-04 @ 5:18 AM
Study NCT ID:
NCT05893056
Status:
RECRUITING
Last Update Posted:
2023-06-27
First Post:
2023-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryoablation Combined With Tislelizumab Plus Lenvatinib In Previously Treated Gastric Cancer Liver Metastasis (CASTLE-09)
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
A Phase II Study to Evaluate the Efficacy and Safety of Cryoablation Combined With Tislelizumab Plus Lenvatinib in Previously Treated Gastric Cancer Liver Metastasis
Status:
RECRUITING
Status Verified Date:
2023-06
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:
CASTLE-09
Brief Summary:
The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Tislelizumab plus Lenvatinib for patients with gastric cancer liver metastasis in the second-/third-Line setting.
Detailed Description:
Recent studies have suggested that local destruction of tumor tissue by cryoablation induced activation and maturation of dendritic cells and tumor-specific T cells by cross-presentation of tumor antigens. While pd-1 blocking antibody interferes with PD-1 mediated T-cell regulatory signaling. And combination of pd-1 blocking antibody plus lenvatinib showed increased ORR in many types of human cancers. Therefore, the objective of this study is to evaluate the efficacy and safety of cryoablation combined with Tislelizumab plus Lenvatinib in previously treated gastric cancer liver metastasis.
Study Oversight
Has Oversight DMC:
False
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?: