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

September 28, 2026 updated by: Chang Gung Memorial Hospital

Prospective 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rodney Cheng-En Hsieh, MD, PhD
  • Phone Number: 7000 +886-3-3281200
  • Email: chsieh@cgmh.org.tw

Study Locations

  • Taiwan
    • Taiwan
      • Taoyuan City, Taiwan, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital at Linkou
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing routine radiotherapy using photons or protons for HCC

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Radiotherapy

Definitive photon or proton radiotherapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 months
Overall Response Rate (ORR)
Time Frame: 12 months

ORR is defined as a complete or partial response according to RECIST1.1.
12 months
Overall survival (OS)
Time Frame: 12 months

OS is defined as the time from signing the informed consent to death from any cause.
12 months
Incidence and severity of adverse events
Time Frame: 12 months

Adverse events will be graded using CTCAE v5
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2024

Primary Completion (Estimated)

March 17, 2029

Study Completion (Estimated)

March 17, 2032

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2026

Last Update Submitted That Met QC Criteria

September 28, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202400364B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sharing individual participant data (IPD) with other researchers requires IRB review and approval. Presently, we do not have a plan to provide IPD to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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