Proton Beam Radiotherapy Followed by Tecentriq and Avastin for Primary Liver Cancer With Vp2-4 Po… (NCT05625893) | Clinical Trial Compass
CompletedPhase 2
Proton Beam Radiotherapy Followed by Tecentriq and Avastin for Primary Liver Cancer With Vp2-4 Portal Vein Invasion
South Korea63 participantsStarted 2023-01-15
Plain-language summary
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).
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Histologically or radiologically confirmed hepatocellular carcinoma based on the guidelines of the Korean Liver Cancer Association-National Cancer Center 2022
✓. Age \>= 20
✓. Vp2-4 portal vein tumor thrombosis diagnosed by dynamic enhanced computed tomography (CT) or maganetic resonance images (MRI) with below finding 1) an intraluminal filling defect adjacent to the primary tumor in Vp2-4 portal vein 2) an enhancement of the filling defect on arterial phase and a washout on portal/delayed phases.
✓. Signed written informed consent
✓. at least one or more measurable intrahepatic viable HCC lesions
✓. Child-Pugh class A within 2 weeks from screening for study registration
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 within 2 weeks from screening for study registration
✓. Life expectancy of at least 16 weeks
Exclusion criteria
✕
What they're measuring
1
Progression-free survival rate
Timeframe: At 9 month
2
Incidence of adverse event assessed according to the Common Terminology Criteria for Adverse Events (CTCAE version 5.0)
Timeframe: From date of atezolizumab and bevacizumab initiatton until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
2. Registration is possible even in the case of hepatic vein tumor infiltration if other selection conditions are satisfied and the exclusion criteria are not met
✕3. no limitation according to the size and number of tumors in the liver.
✕. 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. However, cases with a history of previous upper abdominal radiotherapy (including proton therapy and heavy particle therapy) are excluded.
✕. any type of anticancer agent (including investigational) within 2 weeks before enrollment
✕. Having active brain metastasis or leptomeningeal metastasis need surgery or steroid therapy
✕. Moderate to severe or intractable ascites
✕. A history or presence of hepatic encephalopathy