NCT06379256 Evaluation of Immune Responses and Outcomes in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy
| NCT ID | NCT06379256 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chang Gung Memorial Hospital |
| Condition | Hepatocellular Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-05-23 |
| Primary Completion | 2029-03-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-05-23 with a primary completion date of 2029-03-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06379256 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06379256 currently recruiting?
Yes, NCT06379256 is actively recruiting participants. Contact the research team at chsieh@cgmh.org.tw for enrollment information.
Where is the NCT06379256 trial being conducted?
This trial is being conducted at Taoyuan City, Taiwan.
Who is sponsoring the NCT06379256 clinical trial?
NCT06379256 is sponsored by Chang Gung Memorial Hospital. The trial plans to enroll 300 participants.
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