NCT06858735

HYPERION CCA: a Phase 2 Trial of Systemic Therapy With or Without Liver-directed Radiation Therapy for Patients With Advanced Intrahepatic Cholangiocarcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Durvalumab	Given by IV
DRUG	Gemcitabine	Given by IV
DRUG	Cisplatin	Given by IV

Timeline

• Start date: 2025-06-10
• Primary completion: 2028-11-19
• Completion: 2030-11-19
• First posted: 2025-03-05
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study