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

NCT ID: NCT06379256

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-23
• Study Completion Date: 2032-03-17

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Radiotherapy

Definitive photon or proton radiotherapy

Photon or proton radiotherapy

Intervention Type: 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

Interventions

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

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chang Gung Memorial Hospital at Linkou

Taoyuan, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Rodney Cheng-En Hsieh, MD, PhD

Role: CONTACT

chsieh@cgmh.org.tw

+886-3-3281200 ext. 7000

Facility Contacts

Rodney Cheng-En Hsieh, MD, PhD

Role: primary

rodney445@gmail.com

+88633281200 ext. 7000

Other Identifiers

202400364B0

Identifier Type: -

Identifier Source: org_study_id