Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2025-12-17 @ 4:46 PM
Study NCT ID:
NCT06202716
Status:
None
Last Update Posted:
2024-03-25 00:00:00
First Post:
2024-01-01 00:00:00
Brief Title:
Cadonilimab Plus CapeOX as First-Line Treatment for Advanced GC/GEJC With High TMEscore
Sponsor:
Nanfang Hospital Southern Medical University
Organization:
Nanfang Hospital, Southern Medical University
Study Overview
Official Title:
Cadonilimab Plus CapeOX as First-Line Treatment for Advanced GC/GEJC With High Tumor Microenvironment Score (TMEscore).
Status:
None
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:
This is a single-arm, open-label, multi-center clinical study to evaluate the efficacy and safety of PD-1/CTLA-4 bispecific cadonilimab in combination with oxaliplatin/capecitabine (CapeOX) in the first-line treatment of advanced gastric cancer or gastro-esophageal junction adenocarcinoma with a high tumor microenvironment score (TMEscore). The study plans to enroll 50 patients to receive cadonilimab 100mg/kg, iv, q3w + CapeOX (oxaliplatin 130mg/m2, vd, d1 + capecitabine 1000mg/m2, po, bid, D1-14, q3w, with 3 weeks as a cycle and a maximum of 8 cycles of treatment. Then the maintenance treatment phase with cadonilimab ± capecitabine is entered, and the specific dosage is the same as the treatment period. Effectiveness is assessed every 9 weeks (±7 days) using RECISIT 1.1 until disease recurrence, metastasis, death, or loss of follow-up. The primary endpoint of this study was PFS, and secondary endpoints were OS, ORR, and safety.
Detailed Description:
None
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