Status:
RECRUITING
Atezolizumab and Bevacizumab with Proton Radiotherapy for Unresectable Hepatocellular Carcinoma
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Hepatocellular Carcinoma Non-resectable
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- Participants must have diagnosis of HCC that is deemed unsuitable for surgical resection or transplant. Participants may have multiple lesions with a total maximal tumor dimension of \< 20 cm, and no one lesion \> 15 cm. Diagnosis should be confirmed by at least 1 criterion listed below:
- Histologically or cytologically proven diagnosis of HCC.
- Typical arterial enhancement and delayed washout on multiphasic CT or MRI.
- Age ≥18 years at the time of signing informed consent document.
- ECOG performance status 0-1.
- Barcelona Clinic Liver Cancer (BCLC) stages Intermediate (B) or Advanced (C).
- Child-Pugh score 5-6 liver function within 28 days of study registration.
- Documented virology status of hepatitis B virus (HBV), as confirmed by screening HBV serology test.
- Documented virology status of hepatitis C virus (HCV), as confirmed by screening HCV serology test.
- Ability to understand and the willingness to sign a written informed consent document
- Adequate bone marrow, liver, and renal function within 4 weeks before study registration
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1,000/mm3
- Platelet count ≥ 50,000/μL
- Total bilirubin \< 2.5 mg/dL
- Serum albumin \>2.8 g/dL
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN)
- Prothrombin time ≤ 6 seconds prolonged
- Serum creatinine ≤ 1.5 mg/dL
Exclusion
- Prior invasive malignancy unless disease free for a minimum of 2 years
- Prior radiotherapy to the region of the liver that would result in overlap of radiation therapy fields
- Prior selective internal radiotherapy/hepatic arterial yttrium therapy, at any time
- Untreated active hepatitis B or hepatitis C
- Moderate to severe or intractable ascites
- Presence of distant metastases that cannot be encompassed by proton radiotherapy
- Untreated or incomplete treated esophageal or gastric varices
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration
- Myocardial infarction within the last 6 months prior to study entry
- Acute bacterial or fungal infection requiring intravenous antibiotics within 28 days prior to study entry
- A bleeding episode within 6 months prior to study entry due to any cause.
- Thrombolytic therapy within 28 days prior to study entry.
- Known bleeding or clotting disorder.
- Uncontrolled psychotic disorder
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
- Prior solid organ transplantation.
- Prior or active autoimmune disease (AID) including autoimmune hepatitis, inflammatory bowel disease, myasthenia gravis, systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, and multiple sclerosis.
- Prior or active thrombotic or bleeding disorders, hemoptysis, cerebral vascular accident, significant cardiac disease (ischemic or congestive heart failure), or gastrointestinal perforation.
- Inability to treat all sites of disease by proton radiotherapy (such as extrahepatic metastases or massive liver tumors whereby the liver constraints \[ULV/SLV \>40%\] cannot be met for covering all sites of liver tumors using proton radiotherapy.)
- Known HIV infection.
Key Trial Info
Start Date :
November 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2030
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06133062
Start Date
November 16 2023
End Date
September 30 2030
Last Update
February 19 2025
Active Locations (1)
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1
Chang Gung Memorial Hospital at Linkou
Taoyuan, Taiwan, Taiwan, 333