HYPERION CCA: a Phase 2 Trial of Systemic Therapy With or Without Liver-directed Radiation Therapy for Patients With Advanced Intrahepatic Cholangiocarcinoma
M.D. Anderson Cancer Center
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.
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients older than the age of 18 years old at the time of study entry. 2. Patients with a body mass greater than 30 kg. 3. Patients with a pathological diagnosis of intrahepatic cholangiocarcinoma and at least one intrahepatic tumor measuring 3 cm in greatest dimension 4. Patients must have pathological or radiographic evidence of either: c. locally advanced unresectable iCCA - a multidisciplinary discussion should be documented for patients who have liver confined disease, confirming that the patient is not resectable. d. extrahepatic metastasis at the time of…
Interventions
- DrugDurvalumab
Given by IV
- DrugGemcitabine
Given by IV
- DrugCisplatin
Given by IV
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas