The Value of 68Ga-FAPI PET/CT in the Efficacy Evaluation of Advanced Unresectable Hepatocellular Carcinoma Patients Undergoing Systemic Antitumor Therapy
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
- The responses to systemic antitumor therapy of advanced unresectable hepatocellular carcinoma
研究概览
简要总结
This study aims to investigate the value of 68Ga-FAPI PET/CT in the efficacy evaluation of advanced unresectable hepatocellular carcinoma patients undergoing systemic antitumor therapy.
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-FAPI PET/CT before treatment and after 3-month treatment. The imaging response measurements will be compared with the histopathological 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 unresectable hepatocellular carcinoma patients.
- •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.
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
- •Pregnant women and women who may be pregnant, women who are breastfeeding.
- •Non-compliant person
结局指标
主要结局
The responses to systemic antitumor therapy of advanced unresectable hepatocellular carcinoma
时间窗: Within 1 week of enrollment and up to 3 months
The tumor lesions were evaluated within one week of enrollment and at 3 months of treatment, and a comparison was made before and after. Those with improved tumor lesions were considered to have responded to the treatment, while those without improved tumor lesions were considered to have no response to the treatment.
Standardized uptake value(SUV)
时间窗: Within 1 week of enrollment and after up to 3 months
SUV of 68Ga-FAPI uptake on PET/CT images for tumor lesions
次要结局
- Progress free survival(3 years)
- Overall survival(3 years)