Toripalimab Plus Stereotactic Body Radiotherapy for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: a Single-arm, Prospective Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
To explore the efficacy and safety of toripalimab plus stereotactic body radiotherapy for hepatocellular carcinom with portal vein tumor thrombus.
详细描述
Programmed Cell Death Protein-1 (PD-1) was effective and tolerable in patients with advanced hepatocellular carcinoma. Additionally, previous studies showed that stereotactic body radiotherapy (SBRT) was effective for hepatocellular carcinoma with portal vein tumor thrombus (PVTT). No study has evaluated the efficacy and safety of toripalimab plus SBRT for hepatocellular carcinoma with PVTT. Thus, the investigators carried out this prospective study to find out it.
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
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
- •Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria
- •The normal liver volume in the non-target area was greater than 700ml
- •Portal vein tumor thrumbus confirmed in two image techniques
- •Eastern Cooperative Oncology Group performance status of 0 to 2
- •No Cirrhosis or cirrhotic status of Child-Pugh class A only
- •With no previous radiotherapy and immunotherapy
- •Not applicable for transarterial chemoembolization, surgical resection, and local ablative therapy.
- •The following laboratory parameters:
- •Platelet count ≥ 75,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3 Ability to understand the protocol and to agree to and sign a written informed consent document
排除标准
- •Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- •Known history of HIV
- •History of organ allograft
- •Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- •Evidence of bleeding diathesis.
- •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- •Known central nervous system tumors including metastatic brain disease
研究组 & 干预措施
Toripalimab plus SBRT
Participants received 240mg toripalimab intravenously every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. Participants recevied Stereotactic body radiotherapy. Radiotherapy dose was 36 ~ 54Gy, divided into 6 times of irradiation, and the radiation was performed within 2 weeks.
干预措施: Toripalimab (Drug)
Toripalimab plus SBRT
Participants received 240mg toripalimab intravenously every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. Participants recevied Stereotactic body radiotherapy. Radiotherapy dose was 36 ~ 54Gy, divided into 6 times of irradiation, and the radiation was performed within 2 weeks.
干预措施: Stereotactic body radiotherapy (Radiation)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 6 months
PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on iRECIST, or date of death, whichever occurred first
次要结局
- Objective Response Rate (ORR)(6 months)
- Overall survival (OS)(6 months)
- Adverse Events(6 months)
研究者
Shi Ming
Proffessor
Sun Yat-sen University