Evaluating immune responses in liver cancer patients receiving radiotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.