A Prospective Study on Investigating the Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Hepatobiliary Malignancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluation the responses to immunotherapy of advanced hepatobiliary malignancy
研究概览
简要总结
This study aims to investigate the value of 68Ga-grazytracer in predicting the efficacy of immunotherapy for advanced hepatobiliary malignancies.
详细描述
The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-grazytracer PET/CT after 3 cycles of immunotherapy to evaluate response. The imaging response measurements will be compared with the histopathological or clinical assessment results as gold standard.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Pathological and clinical diagnosis of advanced hepatobiliary malignancy requiring immunotherapy or combination immunotherapy after evaluation according to clinical guidelines
- •Signed and dated informed consent form
- •Commitment to comply with research procedures and co-operation in the implementation of the full research process
- •aged 18-75 years old
- •The patient is in good general condition with an expected survival of > 6 months
排除标准
- •Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
- •Intestinal perforation, complete intestinal obstruction
- •Uncontrolled diabetes patients or fasting blood glucose levels ≥11 mmol/L on the day of the trial
- •Pregnant women and women who may be pregnant, women who are breastfeeding.
- •Non-compliant person
结局指标
主要结局
Evaluation the responses to immunotherapy of advanced hepatobiliary malignancy
时间窗: up to 9 weeks
The value of 68Ga-grazytracer PET in monitoring responses to immunotherapy of advanced hepatobiliary malignancy
Standardized uptake value(SUV)
时间窗: up to 9 weeks
SUV of 68Ga-grazytracer uptake on PET/CT images for tumor lesions
Target-to-background ratio(TBR)
时间窗: up to 9 weeks
68Ga-grazytracer uptake ratio of tumor lesions to mediastinum and liver blood pool on PET/CT images.
次要结局
- Progress free survival(1 years)
- Overall survival(1 years)