Hepatocellular Carcinoma
Conditions
Keywords
Photon Radiotherapy, Proton Radiotherapy, HCC
Brief 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.
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
Sponsors
Chang Gung Memorial Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants must have diagnosis of HCC. Participants may have multiple lesions. Diagnosis should be confirmed by at least 1 criteria listed below: * Histologically or cytologically proven diagnosis of HCC. * Typical arterial enhancement and delayed washout on multiphasic CT or MRI. 2. Age ≥18 years at the time of signing informed consent document. 3. ECOG performance status 0-2. 4. Child-Pugh score 5-9 liver function within 28 days of study registration. 5. Documented virology status of hepatitis B virus (HBV), as confirmed by screening HBV serology test. 6. Documented virology status of hepatitis C virus (HCV), as confirmed by screening HCV serology test. 7. Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
1. Presence of distant metastases that cannot be encompassed by radiotherapy 2. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception 3. Inability to treat all sites of disease by radiotherapy 4. Known HIV infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 12 months | PFS is defined as the time from signing the informed consent to the first occurrence of disease progression or death from any cause (whichever occurs first) according to RECIST1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local control (LC) | 12 months | LC is defined as the time from signing the informed consent to the first occurrence of disease progression in the irradiated field according to RECIST1.1. |
| Time to progression (TTP) | 12 months | TTP is defined as the time from signing the informed consent to the first occurrence of disease progression according to RECIST1.1. |
| Overall Response Rate (ORR) | 12 months | ORR is defined as a complete or partial response according to RECIST1.1. |
| Overall survival (OS) | 12 months | OS is defined as the time from signing the informed consent to death from any cause. |
| Incidence and severity of adverse events | 12 months | Adverse events will be graded using CTCAE v5 |
Countries
Taiwan
Contacts
Primary ContactRodney Cheng-En Hsieh, MD, PhD
Outcome results
None listed