Atezolizumab and Bevacizumab With Stereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Progression-free survival at 6 month
研究概览
简要总结
To determine the efficacy and safety of atezolizumab-bevacizumab combination therapy plus stereotactic body radiotherapy(SBRT) in patients with advanced hepatocellular carcinoma, Subjects will start SBRT for one or more primary cancers and/or metastatic lesions and no more than 5 sites within two month before and after the start date of atezolizumab-bevacizumab combination therapy.
In this study, it is expected to improve the treatment response rate of atezolizumab-bevacizumab therapy, which is currently first-line chemotherapy but has a low treatment response rate.
详细描述
The subjects with advanced hepatocellular carcinoma who are indicated for the first-line atezolizumab-bevacizumab combination therapy are the primary subjects, and if they voluntarily agree to the clinical trial after explanation of the clinical trial, they are included in the clinical trial. Subjects should begin SBRT(stereotactic body radiotherapy) to one or more but not more than five sites for primary cancer and/or metastatic lesions within two month before and after the start date of atezolizumab-bevacizumab combination therapy.
The followings are evaluation items for each visit.
Visit 1 (-6~0 weeks) ± 7days *Screening
- Informed consent form
- Inclusion Criteria/ Exclusion Criteria
- Medical history and physical examination
- Staging via CT, MRI, PET-CT, etc. (PET-CT examination is not compulsory)
- CBC, SMA, PT/aPTT, Tumor markers, Biomarkers
- Stool microbiota NGS
- QoL Questionnaire(EORTC-QLQ-C30 V3)
Visit 2 (0~7 weeks) ± 7 days *During SBRT
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Patients with advanced hepatocellular carcinoma who are indicated for the first-line atezolizumab-bevacizumab combination chemotherapy should begin stereotactic body radiotherapy to one or more but not more than five sites for primary cancer and/or metastatic lesions.
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 to 80 years old
- •Liver function Child-Pugh class A
- •Patient clinically or pathologically diagnosed with hepatocellular carcinoma
- •Advanced hepatocellular carcinoma that is inoperable
- •Satisfies the dose limits for normal organs and lesions of an appropriate size to be included in the scope of radiotherapy.
排除标准
- •Brain metastases
- •Have a history of malignancy other than hepatocellular carcinoma within the last 5 years (except for malignancies with little risk of metastasis or death, e.g., adequately treated cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, tubular carcinoma in situ, or stage 1 uterine cancer.)
- •Subjects with a high probability of untreated gastric or esophageal varices or bleeding
- •Serious uncontrolled medical comorbidities
- •History of liver transplant surgery
- •Autoimmune liver disease
结局指标
主要结局
Progression-free survival at 6 month
时间窗: 6 months after registration
The primary endpoint is to improve 6-month progression-free survival rate in the treatment group compared to those existing literature. Progression-free survival and overall survival are evaluated using the Kaplan-Meier curve. Verified through one sample proportion test.
次要结局
- Overall survival(36 months after registration)
- Objective response rate(36 months after registration)
- Adverse event (Toxicity)(36 months after registration)
- Tumor marker response: AFP, PIVKA-II(36 months after registration)
研究者
Hwa Kyung Byun
Professor
Yonsei University