Evaluating immune responses in liver cancer patients receiving radiotherapy
Prospective Evaluation of Immune Responses and Outcomes in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy
This study is testing how radiotherapy affects the immune system in liver cancer patients to see if it helps them fight the cancer better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Taoyuan City, Taiwan) |
| Trial ID | NCT06379256 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with hepatocellular carcinoma (HCC) undergoing photon or proton radiotherapy. It aims to assess the immune responses and clinical outcomes associated with radiotherapy, building on previous preclinical findings that suggest radiotherapy can enhance anti-tumor T cell responses. The study will evaluate immunological responses and dose-volumetric parameters while identifying predictors of clinical outcomes in these patients. By prospectively gathering data, the study seeks to fill the gap in understanding the immune response to radiotherapy in HCC patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of unresectable hepatocellular carcinoma.
Not a fit: Patients with distant metastases that cannot be treated with radiotherapy or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of immune responses to radiotherapy in liver cancer, potentially leading to improved treatment strategies.
How similar studies have performed: While there have been studies on radiotherapy in HCC, this specific evaluation of immune responses is novel and has not been comprehensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Taoyuan City, Taiwan
- Chang Gung Memorial Hospital at Linkou — Taoyuan City, Taiwan, Taiwan (Recruiting)
Study contacts
- Study coordinator: Rodney Cheng-En Hsieh, MD, PhD
- Email: chsieh@cgmh.org.tw
- Phone: +886-3-3281200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.