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).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR), which is defined as the proportion of patients with complete response (CR) and partial response (PR) at 6 months . CR or PR is assessed in accordance with mRECIST.
研究概览
简要总结
SBRT, atezolizumab, and bevacizumab have different mechanisms of action and can potentially have synergistic effects when combined. SBRT delivers targeted radiation to the tumor, while atezolizumab enhances the immune response, and bevacizumab inhibits angiogenesis. The combination of SBRT with atezolizumab and bevacizumab will result in improved tumor response rates as compared to atezolizumab and bevacizumab alone in patients with advance unresectable hepatocellular carcinoma (HCC). Up until now, no study has been done that has compared SBRT with atezolizumab, and bevacizumab in unresectable advance hepatocellular carcinoma. With this study, investigator aim to study to compare the efficacy and safety of SBRT combined with atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone in the treatment of unresectable advance hepatocellular carcinoma (HCC).
详细描述
Hypothesis: The combination of SBRT with atezolizumab and bevacizumab will result in improved tumor response rates as compared to atezolizumab and bevacizumab alone in patients with advance unresectable hepatocellular carcinoma (HCC).
AIM:- The aim of this study is to compare the efficacy and safety of SBRT combined with atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone in the treatment of unresectable advance hepatocellular carcinoma (HCC).
Study design:
- A prospective observational study.
- Single Centre.
- Open label.
- The study will be conducted in Department of Hepatology, ILBS. Study period: 1 years after ethical approval.
Sample size:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age; 18-70 years.
- •Unresectable advance HCC with PVTT
- •At least one measurable (measurable according to Response Evaluation Criteria In Solid Tumors (mRECIST V.1.1)), untreated lesions.
- •Patients with hepatitis B virus (HBV) infection: HBV-DNA <500 IU/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.
- •Patients with hepatitis C virus (HCV) infection: HCV-DNA <500 IU/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.
- •Maximum diameter of tumor ≤ 15cm
- •Maximum number of tumor nodules ≤5
- •Liver function: Child-Pugh class A, B7; normal liver volume is more than 800cm
- •Karnofsky performance status ≥ 80%
- •The expected survival of the patient is more than 6 months.
- •Agree to accept post-procedure follow-up required by the design of this study.
- •The following conditions are met:
- •i. Platelet≥60×109/L; White blood cell≥3.0×109/L; Hemoglobin≥85 g/L; Serum creatinine≤1.4 × upper limit;. PT-INR ≤1.7
排除标准
- •Patients with untreated or incompletely treated esophageal and/or gastric varices with associated bleeding or at high risk of bleeding.
- •Coinfection with HBV and hepatitis C virus (HCV).
- •Symptomatic, untreated or progressively progressive central nervous system (CNS) metastases.
- •The patient cannot receive follow-up or is participating in other clinical trials.
- •Subjects deemed unsuitable for inclusion in this study by the investigator.
- •Current or past autoimmune disease or immunodeficiency.
- •History of leptomeningitis.
- •Idiopathic pulmonary fibrosis, organising pneumonia or evidence of active pneumonia on chest.
- •Known active tuberculosis.
- •Severe infection within 4 weeks prior to initiation of study treatment
- •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
结局指标
主要结局
Objective response rate (ORR), which is defined as the proportion of patients with complete response (CR) and partial response (PR) at 6 months . CR or PR is assessed in accordance with mRECIST.
时间窗: 6 months
次要结局
- Overall survival(12 months.)
- Disease control rate (DCR) at 6 months, defined as the percentage of subjects with the best response as CR, PR or stable disease (SD).(6 months.)
- Disease control rate (DCR) at12 months, defined as the percentage of subjects with the best response as CR, PR or stable disease (SD).(12 months.)
- Progression-free survival (PFS)(12 months.)
- Number of Participants with biomarkers change ( AFP , PIVKA II) in both groups.(12 months.)
- Disease control rate (DCR) at 3 months, defined as the percentage of subjects with the best response as CR, PR or stable disease (SD).(3 months.)
- Adverse events(12 months.)