Efficacy and Safety of SBRT Combined With Atezolizumab Plus Bevacizumab vs Atezolizumab Plus Bevacizumab in Treating Unresectable Advance Hepatocellular Carcinoma (SAB - A Prospective Observational Study). - SAB

Institute of Liver and Biliary Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•1.Age 18–70 years.
•2.Unresectable advance HCC with PVT
•3.At least one measurable (measurable according to Response Evaluation Criteria In Solid Tumors (mRECIST untreated lesions.
•4.Patients with hepatitis B virus (HBV) infection: HBV-DNA less than 500 IU per mL obtained within 28 days before the start of study treatment and received anti-HBV treatment for at least 28 days before entering the study.
•5.Patients with hepatitis C virus (HCV) infection: HCV-DNA less than 500 IU per mL obtained within 28 days before the start of study treatment and received anti-HCV treatment for at least 28 days before entering the study.
•6.Maximum diameter of tumor less than equals to 15cm
•7.Maximum number of tumor nodules less than equals to 5
•8.Liver function: Child-Pugh class A, B7; normal liver volume is more than 800cm3.
•9.Karnofsky performance status more than equals to 80%
•10.The expected survival of the patient is more than 6 months.
•11.Agree to accept post-procedure follow-up required by the design of this study.
•12.The following conditions are met:
•i.Platelet more than equals to 60 per L; White blood cell more than equals to 3.0×109 per L; Hemoglobin more than equals to 85 g per L; Serum creatinine less than equals to 1.4 upper limit;. PT-INR less than equals to 1.7

•1.Patients with untreated or incompletely treated esophageal and or gastric varices with associated bleeding or at high risk of bleeding.
•2.Coinfection with HBV and hepatitis C virus (HCV).
•3.Symptomatic, untreated or progressively progressive central nervous system (CNS) metastases.
•4.The patient cannot receive follow-up or is participating in other clinical trials.
•5.Subjects deemed unsuitable for inclusion in this study by the investigator.
•6.Current or past autoimmune disease or immunodeficiency.
•7.History of leptomeningitis.
•8.Idiopathic pulmonary fibrosis, organising pneumonia or evidence of active pneumonia on chest.
•9.Known active tuberculosis.
•10.Severe infection within 4 weeks prior to initiation of study treatment
•11.A potential subject who meets any of the following criteria will be excluded from participation in this study:
•i) Previous radiotherapy to the liver
•ii) Known current pregnancy
•iii) Loss of fat planes of tumor with organ at risk like the esophagus, stomach, duodenum, small bowel on CT or on MRI

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