Actively Recruiting
Atezolizumab and Bevacizumab With Proton Radiotherapy for Unresectable Hepatocellular Carcinoma
Led by Chang Gung Memorial Hospital · Updated on 2026-03-20
45
Participants Needed
1
Research Sites
358 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Atezolizumab (anti-programmed death-ligand 1; anti-PD-L1) in conjunction with bevacizumab (anti-vascular endothelial growth factor; anti-VEGF) has become the established standard first-line systemic treatment for unresectable hepatocellular carcinoma (HCC). Despite an improved objective response rate (ORR) of 27%, the majority of patients face HCC progression and liver failure \[Finn et al., N Engl J Med 2020\]. Developing a new combined treatment strategy to overcome resistance to anti-PD-L1 and anti-VEGF is essential to improve patient outcomes. Radiation treatment (RT) is notably effective in managing localized solid tumors and is a fundamental component of unresectable HCC treatment. Recent retrospective cohorts have demonstrated that proton RT targeting all hepatic tumors, along with PD-L1/programmed death-1 (PD-1) blockade, enhances ORR and progression-free survival for unresectable HCC patients, displaying a favorable safety profile (Su et al., Am J Cancer Res. 2022). Our preclinical study (Hsieh et al., Sci Immunol 2022) showcased that RT combined with PD-L1/PD-1 blockade stimulates immunogenic cell death and antigen cross-presentation in murine tumor models, promoting systemic antitumor T cell responses. Nonetheless, it is crucial to verify whether the combined therapy of proton RT, atezolizumab, and bevacizumab triggers synergistic antitumor effects and systemic immune activation in clinical trials for unresectable HCC. This phase II non-randomized trial aims to prospectively evaluate therapeutic efficacy, safety, and immunological responses in patients with unresectable HCC treated with atezolizumab/bevacizumab combined with proton radiotherapy.
CONDITIONS
Official Title
Atezolizumab and Bevacizumab With Proton Radiotherapy for Unresectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of hepatocellular carcinoma unsuitable for surgery or transplant
- Multiple tumors allowed with total size less than 20 cm and no single tumor larger than 15 cm
- Diagnosis confirmed by biopsy or typical imaging features
- Age 18 years or older
- ECOG performance status of 0 or 1
- Barcelona Clinic Liver Cancer stage B or C
- Child-Pugh liver function score between 5 and 6 within 28 days before enrollment
- Documented hepatitis B virus status by blood test
- Documented hepatitis C virus status by blood test
- Ability and willingness to sign informed consent
- Adequate bone marrow, liver, and kidney function within 4 weeks before enrollment including hemoglobin ≥ 9.0 g/dL, neutrophils ≥ 1,000/mm3, platelets ≥ 50,000/µL, total bilirubin < 2.5 mg/dL, albumin > 2.8 g/dL, ALT and AST ≤ 3 times upper normal limit, prothrombin time ≤ 6 seconds prolonged, and serum creatinine ≤ 1.5 mg/dL
You will not qualify if you...
- Previous invasive cancer unless disease-free for at least 2 years
- Prior liver radiotherapy overlapping planned treatment area
- Previous selective internal radiotherapy or hepatic arterial yttrium therapy
- Untreated active hepatitis B or C infection
- Moderate to severe or difficult to control ascites
- Distant metastases that cannot be covered by proton radiotherapy
- Untreated or inadequately treated esophageal or gastric varices
- Severe active medical conditions including unstable angina, recent heart attack, recent serious infections, recent bleeding episodes, thrombolytic therapy within 28 days, known bleeding or clotting disorders, or uncontrolled psychiatric illness
- Pregnancy or inability to use effective contraception
- Previous solid organ transplant
- Prior or active autoimmune diseases such as autoimmune hepatitis, inflammatory bowel disease, or multiple sclerosis
- Prior or active bleeding or clotting disorders, stroke, significant heart disease, or gastrointestinal perforation
- Inability to treat all tumor sites with proton radiotherapy due to liver or metastatic disease
- Known HIV infection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chang Gung Memorial Hospital at Linkou
Taoyuan City, Taiwan, Taiwan, 333
Actively Recruiting
Research Team
R
Rodney Cheng-En Hsieh, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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