Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423170
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-15
Brief Title:
A Single-arm Phase II Clinical Study of the Efficacy and Safety of Camrelizumab Combined With GEMOX for Unresectable GBCs
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
Camrelizumab Plus Gemcitabine and Oxaliplatin GEMOX in Patients for Unresectable Gallbladder Cancer a Single-arm Phase II Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The aim of this study was to evaluate the efficacy and safety of Camrelizumab combined with gemcitabine and oxaliplatin GEMOX for unresectable gallbladder cancer Patients with unresectable gallbladder cancer were enrolled to receive gemcitabine 1000mgm2 D1oxaliplatin 100mgm2 D1Camrelizumab 200mg D1 in 21-day cycles for 6-8 cycles with serum tumour markers assessed at each course and abdominal CTA performed every two courses until tumour progression occursThe primary indicators of this study are radical tumor resection rate secondary indicators are disease control rate objective response rateprogression-free survival and overall survival safety indicators incidence and severity of adverse events AEs and serious adverse events SAEs according to NCI-CTCAEv50 criteria 37 patients are expected to be recruited for this study
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