Actively Recruiting
HYPERION CCA: a Phase 2 Trial of Systemic Therapy With or Without Liver-directed Radiation Therapy for Patients With Advanced Intrahepatic Cholangiocarcinoma
Led by M.D. Anderson Cancer Center · Updated on 2026-03-11
60
Participants Needed
1
Research Sites
284 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HYPERION CCA: a Phase 2 Trial of Systemic Therapy With or Without Liver-directed Radiation Therapy for Patients With Advanced Intrahepatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years at study entry
- Body mass greater than 30 kg
- Pathological diagnosis of intrahepatic cholangiocarcinoma with at least one intrahepatic tumor measuring 3 cm or more
- Pathological or radiographic evidence of locally advanced unresectable iCCA or extrahepatic metastasis at enrollment, including non-regional lymph nodes, lung, and/or bone
- Receipt of at least 4 cycles of systemic therapy with gemcitabine, cisplatin, and durvalumab, or agreement by treating team if any drug was held during initial cycles
- Suitable candidates for radiation therapy with adequate liver function as determined by physician
- Pre-registration allowed before cycle 4 if all other criteria met except systemic therapy cycles
- Adequate organ and marrow function as defined by specified blood counts and organ function tests
- Life expectancy of at least 12 weeks
- At least one lesion qualifying as a RECIST 1.1 target lesion at baseline with recent CT or MRI tumor assessment
- Capable of giving signed informed consent and complying with study requirements
- Willing and able to comply with protocol for treatment duration and scheduled visits
You will not qualify if you...
- Participation in another clinical study with investigational product within the last month
- Concurrent enrollment in another clinical study unless observational or during follow-up
- Unresolved toxicity Grade 2 or higher from previous therapy except alopecia, vitiligo, and specified lab values
- Concurrent chemotherapy, investigational, biologic, or hormonal cancer therapy other than specified
- Major surgery within 28 days prior to first dose, except local surgery for palliation
- History of allogenic organ transplantation
- Active or prior autoimmune or inflammatory disorders with listed exceptions
- Uncontrolled illness or conditions that limit compliance or increase risk
- History of another primary malignancy with specified exceptions
- History of leptomeningeal carcinomatosis
- Brain metastases confirmed by imaging
- QTcF interval over 470 ms on ECG
- History of active primary immunodeficiency
- Known active hepatitis infection or positive viral markers with specific conditions and monitoring
- Known HIV infection not well controlled by defined criteria
- Use of immunosuppressive medication within 14 days before first dose with exceptions
- Receipt of live attenuated vaccine within 30 days before first dose
- Pregnancy, breastfeeding, or unwillingness to use effective birth control during study and 90 days after
- Known allergy or hypersensitivity to study drugs or excipients
- Prior participation in durvalumab clinical study
- Prior anti-PD-1 or anti-PD-L1 treatment with specific restrictions
- Judgment by physician of unsuitability or inability to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Eugene Koay, MD,PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here