Actively Recruiting
Evaluation of Immune Responses and Outcomes in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy
Led by Chang Gung Memorial Hospital · Updated on 2025-05-14
300
Participants Needed
1
Research Sites
407 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Radiation therapy is a highly effective modality for managing localized solid tumors and has become a fundamental component of treating unresectable hepatocellular carcinoma. Our previous preclinical investigation revealed that radiotherapy can initiate immunogenic cell death and facilitate the cross-presentation of tumor antigens by antigen-presenting cells, thereby augmenting systemic anti-tumor T cell responses in murine tumor models. However, this immune response subsequent to irradiation has not been comprehensively evaluated in clinical trials involving hepatocellular carcinoma patients. Given that radiotherapy represents a standard therapeutic approach for unresectable hepatocellular carcinoma, our ongoing phase II non-randomized trial aims to prospectively assess immunological responses and dose-volumetric parameters, while identifying predictors of clinical outcomes in patients undergoing definitive radiotherapy for hepatocellular carcinoma.
CONDITIONS
Official Title
Evaluation of Immune Responses and Outcomes in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with hepatocellular carcinoma confirmed by histology, cytology, or imaging
- Age 18 years or older
- ECOG performance status between 0 and 2
- Child-Pugh liver function score between 5 and 9 within 28 days before enrollment
- Documented hepatitis B virus (HBV) status confirmed by serology
- Documented hepatitis C virus (HCV) status confirmed by serology
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Presence of distant metastases not treatable by radiotherapy
- Pregnancy or women of childbearing potential and men who are sexually active and unwilling or unable to use medically acceptable contraception
- Inability to treat all disease sites with radiotherapy
- Known HIV infection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chang Gung Memorial Hospital at Linkou
Taoyuan City, Taiwan, Taiwan, 333
Actively Recruiting
Research Team
R
Rodney Cheng-En Hsieh, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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