Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04720131
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2021-01-20
Brief Title:
Camrelizumab Combined With Apatinib and Capecitabine in Patients With Advanced Biliary Tract Cancer
Sponsor:
Beijing Friendship Hospital
Organization:
Beijing Friendship Hospital
Study Overview
Official Title:
Camrelizumab Combined With Apatinib and Capecitabine for Patients With Advanced Biliary Tract Cancer a Phase 2 Single-arm Prospective Study
Status:
COMPLETED
Status Verified Date:
2024-01
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:
Biliary tract cancer BTC is a series of rare malignancies with poor overall prognosis Radical surgery the preferred treatment option but most patients have lost the opportunity of surgery at the time of diagnosis At present there are limited systematical treatment options for biliary tract cancer with poor efficacy and short duration of responses In the past few years immune checkpoint inhibitors ICIs therapy has gradually been added to the advanced biliary comprehensive treatment However in view of the low incidence and high heterogeneity of BTC more large number of clinical trials and practices need to be carried out and the effective combination regimens and predictive biomarkers need to be explored This study is a single-arm open-label prospective cohort study combining Camrelizumab with apatinib and capecitabine as the first-line or second-line treatment for patients with advanced biliary tract cancer The study aims to explore the efficacy and safety of the combination regimen and try to find biomarkers that can guild treatment In this study 34 patients were enrolled by the Simons two-stage design with the objective response rate as the primary endpoint and the disease control rate progression-free survival overall survival and safety as secondary endpoints It is expected that the three-drug combination regimen will have significant efficacy and manageable adverse reactions and predictive biomarkers can be found
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