Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06013943
Status:
RECRUITING
Last Update Posted:
2023-09-15
First Post:
2023-04-12
Brief Title:
Envafolimab Combined With GEMOX in First-line Treatment of Advanced GBC
Sponsor:
Eastern Hepatobiliary Surgery Hospital
Organization:
Eastern Hepatobiliary Surgery Hospital
Study Overview
Official Title:
Envafolimab Combined With GEMOX in First-line Treatment of Advanced Gallbladder Cancer A Single Center Single Arm Phase II Trial
Status:
RECRUITING
Status Verified Date:
2023-09
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 TOPAZ-1 study compared the advantages and disadvantages of immune checkpoint inhibitor anti-PD-L1 antibody combined with GemCis chemotherapy Gemcitabine and Cisplatin and GemCis chemotherapy alone in first-line treatment of advanced biliary tract tumors BTC which including gallbladder cancer It was observed that chemotherapy combined with PD-L1 antibody improved progression-free survival PFS and overall survival OS
As a standard first-line chemotherapy regimen for BTC too Gemox chemotherapy gemcitabine and cisplatin has a median OS of 95 months and non-inferior survival time to GemCis chemotherapy In addition Gemox chemotherapy has been widely used in clinical practice because it reduces the requirement on patients renal function and has good tolerance Envafolimab is a novel fusion of humanized mono-domain PD-L1 antibody and human IgG Fc fragment which has shown good efficacy and safety in a variety of solid tumors It is safe and convenient to administer by subcutaneous injection However there is currently no clinical data on Envafolimab combined with GEMOX chemotherapy in patients with advanced gallbladder cancer GBC
The goal of this clinical trial is to evaluate its efficacy and related safety in patients with GBC Eligible participants will receive Envafolimab up to 12 months plus gemcitabine and cisplatin up to 6-8 cycles until progression of radiological disease unacceptable toxicity or withdrawal from the study whichever comes firstThe primary endpoint was the 6-month PFS rate
As a standard first-line chemotherapy regimen for BTC too Gemox chemotherapy gemcitabine and cisplatin has a median OS of 95 months and non-inferior survival time to GemCis chemotherapy In addition Gemox chemotherapy has been widely used in clinical practice because it reduces the requirement on patients renal function and has good tolerance Envafolimab is a novel fusion of humanized mono-domain PD-L1 antibody and human IgG Fc fragment which has shown good efficacy and safety in a variety of solid tumors It is safe and convenient to administer by subcutaneous injection However there is currently no clinical data on Envafolimab combined with GEMOX chemotherapy in patients with advanced gallbladder cancer GBC
The goal of this clinical trial is to evaluate its efficacy and related safety in patients with GBC Eligible participants will receive Envafolimab up to 12 months plus gemcitabine and cisplatin up to 6-8 cycles until progression of radiological disease unacceptable toxicity or withdrawal from the study whichever comes firstThe primary endpoint was the 6-month PFS rate
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