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

NCT06379256 | Recruiting

• 1 other identifier: 202400364B0
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Photon Radiotherapy; Proton Radiotherapy; HCC

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  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 Outcomes (5)

• Local control (LC)

  12 months

• Time to progression (TTP)

  12 months

• Overall Response Rate (ORR)

  12 months

• Overall survival (OS)

  12 months

• Incidence and severity of adverse events

  12 months

Study Arms (1)

Radiotherapy

Definitive photon or proton radiotherapy

Radiation: Photon or proton radiotherapy

Interventions

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

Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing routine radiotherapy using photons or protons for HCC

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital at Linkou

Taoyuan, Taiwan, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Photons

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Elementary Particles; Physical Phenomena; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Central Study Contacts

Rodney Cheng-En Hsieh, MD, PhD

CONTACT

+886-3-3281200; chsieh@cgmh.org.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: May 23, 2024
• Primary Completion (Estimated): March 17, 2029
• Study Completion (Estimated): March 17, 2032
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)