Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06379256

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital at Linkou

Taoyuan City, Taiwan, 333

Location status: Recruiting

Location contact

Rodney Cheng-En Hsieh, MD, PhD

CONTACT

[email protected]

+88633281200 ext. 7000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Photon or proton radiotherapy

Radiation
  • 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 outcomes

  1. Progression free survival (PFS)

    Time frame: 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 outcomes

  1. Local control (LC)

    Time frame: 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.

  2. Time to progression (TTP)

    Time frame: 12 months

    TTP is defined as the time from signing the informed consent to the first occurrence of disease progression according to RECIST1.1.

  3. Overall Response Rate (ORR)

    Time frame: 12 months

    ORR is defined as a complete or partial response according to RECIST1.1.

  4. Overall survival (OS)

    Time frame: 12 months

    OS is defined as the time from signing the informed consent to death from any cause.

  5. Incidence and severity of adverse events

    Time frame: 12 months

    Adverse events will be graded using CTCAE v5

Study contacts

Contact information is provided by the study sponsor or research team.

Rodney Cheng-En Hsieh, MD, PhD

CONTACT

[email protected]

+886-3-3281200 ext. 7000

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2032
First posted
Apr 23, 2024
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.