KCT0008001
Not yet recruiting
未知
Proton Beam Radiotherapy Followed by Tecentriq and Avastin for Primary Liver Cancer With Vp2-4 Portal Vein Invasion
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Samsung Medical Center
- Enrollment
- 32
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Signed written informed consent
- •2\.over 20 years of age
- •3\.Histologically confirmed hepatocellular carcinoma(HCC)
- •4\.at least one or more measurable intrahepatic viable HCC lesions by dynamic enhanced computed tomography (CT) or maganetic resonance images (MRI)
- •5\.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(portal vein, hepatic vein, and/or inferior vena cava)
- •2\) an enhancement of the filling defect on arterial phase and a washout on portal/delayed phases.
- •6\.Child\-Pugh class A
- •7\.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0\-1
- •8\.Life expectancy of at least 16 weeks
Exclusion Criteria
- •1\.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.
- •2\.any type of anticancer agent (including investigational) within 2 weeks before enrollment
- •3\.Having active brain metastasis or leptomeningeal metastasis need surgery or steroid therapy
- •4\.Moderate to severe or intractable ascites
- •5\.A history or presence of hepatic encephalopathy
- •6\.Presence of active bacterial infection
- •7\.Active hepatitis B infection status, untreated active chronic hepatitis B or active hepatitis C infection
- •8\.History of portal hypertension with bleeding within the past 6 months
- •9\.Prior liver transplant
- •10\.Uncontrolled severe medical comorbidity(Active tuberculosis, acute infection, acute ischemic heart disease, peptic ulcer disease)
Outcomes
Primary Outcomes
Not specified
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