RecruitingNCT06379256

Evaluation of Immune Responses and Outcomes in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy

Prospective Evaluation of Immune Responses and Outcomes in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy


Sponsor

Chang Gung Memorial Hospital

Enrollment

300 participants

Start Date

May 23, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how the immune system responds during radiation therapy for liver cancer (hepatocellular carcinoma) and whether those immune responses affect treatment outcomes. Researchers will track blood immune markers throughout treatment. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of liver cancer (HCC) - Your liver is functioning adequately (Child-Pugh score 5-9) - You are in reasonably good health (ECOG 0-2) - You have had your hepatitis B and C status tested - You are willing and able to give informed consent **You may NOT be eligible if...** - Your liver cancer is not suitable for radiation therapy - Your liver function is too poor - You are unable to consent to the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONPhoton or proton radiotherapy

* 39.6-72.6 Gy (or Cobalt Gray Equivalent, CGE) in 22 fractions for tumors ≤1 cm from hepatic hilum, bowel, and heart. * 30-66 Gy (or CGE) in 10 fractions for tumors \>1 cm from hepatic hilum, bowel, and heart. * 27.5-60 Gy (or CGE) in 5 fractions using stereotactic body radiation therapy (SBRT) techniques


Locations(1)

Chang Gung Memorial Hospital at Linkou

Taoyuan City, Taiwan, Taiwan

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NCT06379256


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