OncoMatch/Clinical Trials/NCT05625893
Proton Beam Radiotherapy Followed by Tecentriq and Avastin for Primary Liver Cancer With Vp2-4 Portal Vein Invasion
Is NCT05625893 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for hepatocellular carcinoma.
This study is investigator initiated, single-institution, prospective, phase 2 open-label study to determine the efficacy and safety of combination therapy of atezolizumab/bevacizumab and proton beam therapy to portal vein tumor thrombosis with or without main primary tumor in patients with stage 3 or higher hepatocellular carcinoma (HCC) with Vp2-4 portal vein invasion who had not undergone systemic therapy for HCC. The primary endpoint of this study is progression-free survival and secondary endpoints are overall survival (OS), time to progression (TTP), objective response rate, disease control rate (DCR), and time to local disease progression (LTP).
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: adjuvant therapy or treatment for other cancers or local HCC treatment allowed
previous history of systemic treatment for HCC (If systemic treatment for HCC has been performed at least once, it will not be enrolled in this study.) However, registration is permitted if the previous systemic treatment is for adjuvant purposes or treatment for other cancers. Also allowed if previous HCC treatment is local treatment.
Cannot have received: upper abdominal radiotherapy (proton therapy, heavy particle therapy)
cases with a history of previous upper abdominal radiotherapy (including proton therapy and heavy particle therapy) are excluded
Cannot have received: any anticancer agent (including investigational)
any type of anticancer agent (including investigational) within 2 weeks before enrollment
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1,000/mm3; Platelet count ≥ 50,000/μL
Kidney function
Serum creatinine ≤ 1.5 mg/dL
Liver function
Total bilirubin < 2.5 mg/dL; Serum albumin >2.8 g/dL; ALT and AST ≤ 5 × ULN; Prothrombin time in INR ≤ 1.8 × ULN; Child-Pugh class A
adequate bone marrow and liver function within 2 weeks from screening for 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) ≤ 5 × upper limit of normal (ULN) * Prothrombin time in INR ≤ 1.8 × ULN * Serum creatinine ≤ 1.5 mg/dL Child-Pugh class A within 2 weeks from screening for study registration
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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