Clinical trial NCT06379256: Evaluation of Immune Responses and Outcomes in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy
Official title: Prospective Evaluation of Immune Responses and Outcomes in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Keywords: Photon Radiotherapy
Proton Radiotherapy
HCC
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing routine radiotherapy using photons or protons for HCC

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.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 12 months
Secondary outcomes:
measure: Local control (LC)
timeFrame: 12 months
measure: Time to progression (TTP)
timeFrame: 12 months
measure: Overall Response Rate (ORR)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 12 months
measure: Incidence and severity of adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital at Linkou
Study officials:
References: