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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06379256
• Other study ID #: 202400364B0
• Status: Not yet recruiting
• Start date: April 26, 2024
• Est. completion date: March 17, 2032

Study information

• Verified date: April 2024
• Source: Chang Gung Memorial Hospital
• Contact: Rodney Cheng-En Hsieh, MD, PhD
• Phone: +886-3-3281200
• Email: chsieh[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Radiation therapy (RT) is a highly effective modality for managing localized solid tumors and has become a fundamental component of treating unresectable hepatocellular carcinoma (HCC). Our previous preclinical investigation (Hsieh et al., Science Immunology 2022) revealed that RT 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 HCC patients. Given that RT represents a standard therapeutic approach for unresectable HCC, 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 RT for HCC.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 17, 2032
• Est. primary completion date: March 17, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Radiation:
• 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

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital at Linkou	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)	PFS is defined as the time from signing the informed consent to the first occurrence of disease progression or death from any cause (whichever occurs first) according to RECIST1.1.	12 months
Secondary	Local control (LC)	LC is defined as the time from signing the informed consent to the first occurrence of disease progression in the irradiated field according to RECIST1.1.	12 months
Secondary	Time to progression (TTP)	TTP is defined as the time from signing the informed consent to the first occurrence of disease progression according to RECIST1.1.	12 months
Secondary	Overall Response Rate (ORR)	ORR is defined as a complete or partial response according to RECIST1.1.	12 months
Secondary	Overall survival (OS)	OS is defined as the time from signing the informed consent to death from any cause.	12 months
Secondary	Incidence and severity of adverse events	Adverse events will be graded using CTCAE v5	12 months