Ignite Creation Date:
2024-05-06 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03486678
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
2018-02-01
Brief Title:
SHR-1210 in Combination With GEMOX in Patients With Advanced BTC
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
A Single-arm Open-label and Exploratory Clinical Study of PD-1 Monoclonal Antibody SHR-1210 in Combination With GEMOX Gemcitabine Combined Oxaliplatin in Patients With Advanced Biliary Tract Cancer
Status:
COMPLETED
Status Verified Date:
2021-10
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 a single-arm open-label and exploratory clinical study of PD-1 monoclonal antibody SHR-1210 combined with GEMOX regimen gemcitabine combined oxaliplatin in the treatment of advanced biliary malignancies
In oder to observe and evaluate the efficacy and safety of PD-1 antibody SHR-1210 combined with GEMOX in the treatment of patients with advanced biliary malignant tumor BTCsubjects with pathological confirmed biliary cancer including intrahepatic bile duct carcinoma extrahepatic bile duct carcinoma and gallbladder carcinoma will be enrolled
28 days as a treatment cycle SHR-1210 3mgkg and Gemcitabine 800 mgm2 will be administered IV Q2W D1 and D15 of a treatment cycleand Oxaliplatin 85mgm2 will be administered IV Q2W D2 and D16 of a treatment cycle PD-1 antibody combined chemotherapy will be used up to 6 cyclesSHR-1210 3mgkg IV Q2W will be administered beyond 6 cycles chemotherapy until disease progression or un-tolerable toxicity
In oder to observe and evaluate the efficacy and safety of PD-1 antibody SHR-1210 combined with GEMOX in the treatment of patients with advanced biliary malignant tumor BTCsubjects with pathological confirmed biliary cancer including intrahepatic bile duct carcinoma extrahepatic bile duct carcinoma and gallbladder carcinoma will be enrolled
28 days as a treatment cycle SHR-1210 3mgkg and Gemcitabine 800 mgm2 will be administered IV Q2W D1 and D15 of a treatment cycleand Oxaliplatin 85mgm2 will be administered IV Q2W D2 and D16 of a treatment cycle PD-1 antibody combined chemotherapy will be used up to 6 cyclesSHR-1210 3mgkg IV Q2W will be administered beyond 6 cycles chemotherapy until disease progression or un-tolerable toxicity
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