Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 7:12 AM
Study NCT ID:
NCT03898895
Status:
UNKNOWN
Last Update Posted:
2022-06-02
First Post:
2019-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COmbination of Radiotherapy With Anti-PD-1 Antibody for unREseCtable Biliary Tract Cancer
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
Combination of Radiotherapy With Anti-PD-1 Antibody for Unresectable Biliary Tract Cancer
Status:
UNKNOWN
Status Verified Date:
2022-05
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:
CORRECT
Brief Summary:
The study is a single-arm, phase II trial. The purpose is to investigate both the efficacy and safety of radiotherapy combined with anti-PD-1 antibody in unresectable biliary tract cancer patients.
Detailed Description:
The trial will recruit 36 patients, and they will undergo radiotherapy plus anti-PD-1 antibody. Patients will receive conventional intensity-modulated radiotherapy or stereotactic body radiation therapy first for a total dose more than 45Gy. Camrelizumab 200mg intravenously every 3 weeks will be initiated within 7 days after radiotherapy.
Study Oversight
Has Oversight DMC:
True
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?: