Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-02 @ 10:54 AM
Study NCT ID:
NCT06858735
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HYPERION CCA: a Phase 2 Trial of Systemic Therapy With or Without Liver-directed Radiation Therapy for Patients With Advanced Intrahepatic Cholangiocarcinoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
HYPERION CCA: a Phase 2 Trial of Systemic Therapy With or Without Liver-directed Radiation Therapy for Patients With Advanced Intrahepatic Cholangiocarcinoma
Status:
RECRUITING
Status Verified Date:
2025-09
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 study will compare outcomes for M1 iCCA patients treated with and without L-RT by reviewing iCCA patients found to have M1 disease at initial diagnosis at a single institution between 2010 and 2021 who received L-RT.
Detailed Description:
Primary Objective:
To assess the overall survival of patients treated with standard of care systemic therapy with or without liver-directed hypofractionated adaptive RT.
Secondary Objectives:
* Patient-reported quality of life as per the FACT-Hep inventory
* Progression-free survival
* Cause of death
To assess the overall survival of patients treated with standard of care systemic therapy with or without liver-directed hypofractionated adaptive RT.
Secondary Objectives:
* Patient-reported quality of life as per the FACT-Hep inventory
* Progression-free survival
* Cause of death
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-01520 | OTHER | NCI-CTRP Clinical Trials Registry | View |