Ignite Creation Date:
2024-05-06 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05156788
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-15
First Post:
2021-09-30
Brief Title:
TislelizumabAnti PD-1 Lenvatinib and GEMOX Transformation in the Treatment of Potentially Resectable Locally Advanced Biliary Tract Cancer
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
A Single-arm Multi-center Phase II Study of Tislelizumab Lenvatinib and GEMOX Transformation in the Treatment of Potentially Resectable Locally Advanced Biliary Tract Cancer
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:
The aim of this study is to assess the R0 resection rate of tislelizumab combined with Lenvatinib and Gemox chemotherapy in the conversion therapy of potentially resectable locally advanced BTC
Detailed Description:
Translational therapy refers to methods such as chemotherapy radiotherapy immunotherapy targeted and combined therapy to shrink tumors reduce tumor biological behavior and achieve secondary resection The success rate of transformation depends on the objective response rate of the treatment method Objective response rate ORR The latest review showed that 132 patients with unresectable ICC had undergone chemotherapy chemoembolization radiotherapy embolization or combination therapy and 27 patients received downgrade resection The research of our group using PD-1 antibody combined with lenvatinib and Gemox chemotherapy in the first-line treatment of unresectable advanced cholangiocarcinoma NCT03951597 2020ESMO 2021ASCO showed that the ORR was 80 and the disease control rate DCR It reached 933 2830 of which 3 cases underwent successful radical resection after downstage These data suggest that PD1 monoclonal antibody combined with lenvatinib and Gemox chemotherapy may be an ideal conversion therapy for patients with potentially resectable advanced biliary system tumors but there is currently no evidence-based basis
This study explores the efficacy and safety of PD1 monoclonal antibody combined with Lenvatinib and Gemox chemotherapy in potentially resectable advanced BTC conversion therapy It has certain clinical significance in order to increase the R0 surgical resection rate of BTC patients and improve patient survival
This study explores the efficacy and safety of PD1 monoclonal antibody combined with Lenvatinib and Gemox chemotherapy in potentially resectable advanced BTC conversion therapy It has certain clinical significance in order to increase the R0 surgical resection rate of BTC patients and improve patient survival
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