Ignite Creation Date:
2024-05-06 @ 10:39 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03311789
Status:
UNKNOWN
Last Update Posted:
2017-10-17
First Post:
2017-10-04
Brief Title:
Study of PD-1 Inhibitor in Combination With GemcitabineCisplatin for Advancer BTCs
Sponsor:
Chinese PLA General Hospital
Organization:
Chinese PLA General Hospital
Study Overview
Official Title:
A Pilot Study of PD-1 Inhibitor in Combination With GemcitabineCisplatin for Patients With Advanced Unresectable or Metastatic Biliary Tract Cancers
Status:
UNKNOWN
Status Verified Date:
2017-10
Last Known Status:
RECRUITING
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 phase III trial in biliary tract cancer BTC patients The purpose of this trial is to evaluate the safety and effect of PD-1 inhibitor in combination with gemcitabinecisplatin chemotherapy in patients with advanced unresectable or metastatic BTCs
The primary objective 6-month progression free survival PFS The second objectives objective clinical responseaccording to RECIST version 11 safety symptom control and quality of life QoL according to EORTC QoL C30 and BIL 21 overall survival The exploratory objectives assessment of immunological response cytokines lymphocyte phenotype immunoglobulins and evaluation of pathological immunological and clinical predictive factors for responsetoxicity
The primary objective 6-month progression free survival PFS The second objectives objective clinical responseaccording to RECIST version 11 safety symptom control and quality of life QoL according to EORTC QoL C30 and BIL 21 overall survival The exploratory objectives assessment of immunological response cytokines lymphocyte phenotype immunoglobulins and evaluation of pathological immunological and clinical predictive factors for responsetoxicity
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