CTRI/2025/04/084493尚未招募2 期
Phase II, single arm prospective multicentre interventional study of SBRT (Stereotactic body radiotherapy) and Atezolizumab with Bevacizumab in unresectable Hepatocellular carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Overall Response rate ORR as per modified RECIST mRECIST. ORR will be a sum of
研究概览
简要总结
The current single arm phase II study aims to explore the combination of atezolizumabbevacizumab with SBRT in patients with advanced and unresectable Hepatocellular carcinoma HCC. The primary aim of the study will be to evaluate whether the combination will improveoverall response rates ORR in comparison to historical controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •General Inclusion criteria Major Age more than equal to 18 years at the time of signing informed consent document.
- •ECOG performance status 0 to 2 Child-Pugh Score less than equal to B7 within one week of study enrolment Patients with both MPVT Vp3 or Vp4 and Child-Pugh Score B7 concurrently will not enroll in study Barcelona Clinic Liver Cancer BCLC stages Intermediate B or Advanced C within 7 days of study registration.
- •Adequate end organ function Inclusion criteria for Hepatitis B & Hepatitis C Documented virology status of hepatitis B virus HBV as confirmed by screening HBV serology test within 28 days prior to study registration.
- •For participants with evidence of chronic HBV infection the HBV viral load must be undetectable on suppressive therapy if indicated.
- •For participants with active HBV HBV DNA less than 500 IU per mL obtained within 28 days prior to initiation of study treatment and AntiHBV treatment per local standard of care eg entecavir for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study.
- •Documented virology status of hepatitis C virus HCV as confirmed by screening HCV serology test within 28 days prior to study registration.
- •Inclusion criteria HCC related Major Participants must have diagnosis of hepatocellular carcinoma HCC that is deemed unresectable, not a candidate for surgery RFA or further TACE.
- •Histologically or cytologically proven diagnosis of HCC At least 1 solid liver lesion more than 1 cm with arterial enhancement and delayed washout on multiphasic CT or MRI.
- •Maximum 5 lesions allowing minimum 700 cc of the spared liver volume Enhancing vascular thrombosis demonstrating arterial enhancement and delayed washout of multiphasic MRI.
- •Macrovascular invasion VP4 is allowed.
- •Radiologic imaging evaluation must occur within 30 days prior to study registration.
- •Participants must have measurable disease Small volume extrahepatic disease permitted defined as less than 2 cm in sum of maximal diameters is allowable only for the presence of regional lymph nodes.
排除标准
- •Patients with CTPB7 and VP4or VP3 status together ie if patients have VP3 or Vp4 status they will not be included if they have CTPB7 status.
- •Conversely, if patient has CTPB7 status, they will not be included if they have VP3 or VP4 status.
- •Prior systemic therapy, including tyrosine kinase inhibitors or immunotherapy Prior radiotherapy Prior selective internal radiotherapy SIRT or hepatic arterial Yttrium therapy, at any time.
- •Direct tumor extension into the stomach, duodenum, small bowel or large bowel.
- •Extrahepatic metastases unless as specified previously for locoregional lymph nodes Known fibrolamellar HCC, sarcomatoid HCC or biphenotypic 8 HCC.
- •History of leptomeningeal disease.
- •Active or history of autoimmune disease or immune deficiency Any specific contraindications to receive immune-checkpoint inhibitors Uncontrolled comorbidities.
结局指标
主要结局
Overall Response rate ORR as per modified RECIST mRECIST. ORR will be a sum of
时间窗: Accrual of 24 months plus 12 onth
complete response CR and partial response PR rates
时间窗: Accrual of 24 months plus 12 onth
次要结局
- Progression free survival PFS at 12 months(Overall Survival OS at 12 months)
研究者
研究点 (1)
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