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Recruiting NCT06379256

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

— Observational Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Photon or proton radiotherapy.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Radiation Photon 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

Primary outcome measures

  • Progression free survival (PFS) [Time frame: 12 months]
Secondary outcome measures (5)
  • Local control (LC) [Time frame: 12 months]
  • Time to progression (TTP) [Time frame: 12 months]
  • Overall Response Rate (ORR) [Time frame: 12 months]
  • Overall survival (OS) [Time frame: 12 months]
  • Incidence and severity of adverse events [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • 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.
  • Age ≥18 years at the time of signing informed consent document.
  • ECOG performance status 0-2.
  • Child-Pugh score 5-9 liver function within 28 days of study registration.
  • Documented virology status of hepatitis B virus (HBV), as confirmed by screening HBV serology test.
  • Documented virology status of hepatitis C virus (HCV), as confirmed by screening HCV serology test.
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

  • Presence of distant metastases that cannot be encompassed by radiotherapy
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Inability to treat all sites of disease by radiotherapy
  • Known HIV infection.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Taiwan · 1 center
  • Chang Gung Memorial Hospital at Linkou — Taoyuan City

Identifiers

NCT: NCT06379256 · 202400364B0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗