Ignite Creation Date:
2024-05-06 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05023109
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-15
First Post:
2021-08-20
Brief Title:
GP Chemotherapy in Combination With Anti-PD-1 and Anti-TIGIT in Unresectable Advanced BTC
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
A Study to Evaluate GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Participants With Unresectable Advanced Biliary Tract Carcinoma BTC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
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 an open label multi-center phaseâ…¡study to evaluate the efficacy and safety of GP GemcitabineCisplatin in combination with Tislelizumab and Ociperlimab as first-line treatment in participants with unresectable advanced Biliary Tract Carcinoma BTC
Detailed Description:
Biliary Tract Carcinoma BTC has an insidious onset invasiveness high malignancy and no specific symptoms in the early stage and most of them are in the middle and advanced stages at the time of diagnosis and have lost the chance of surgery For patients with advanced BTC systemic therapy is currently the main choice and gemcitabinecisplatin GP is currently the gold standard for first-line treatment of advanced BTC but the efficacy is still unsatisfactory and more and more clinical practice has found that GP-based combination therapy may have better efficacy
Previous studies have shown that chemotherapy can improve the immunotherapy microenvironment and may have a synergistic anti-tumor effect in combination with immunotherapy This study is to explore the efficacy and safety of GP in combination with anti-PD1 antibody Tislelizumab and anti-TIGIT antibody Ociperlimab as first-line treatment in participants with unresectable advanced BTC
Previous studies have shown that chemotherapy can improve the immunotherapy microenvironment and may have a synergistic anti-tumor effect in combination with immunotherapy This study is to explore the efficacy and safety of GP in combination with anti-PD1 antibody Tislelizumab and anti-TIGIT antibody Ociperlimab as first-line treatment in participants with unresectable advanced BTC
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