Optimizing Outcomes of Patients With Advanced HCC Undergoing Immunotherapy Through Novel 68Ga PSMA PET Imaging
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Time to treatment response
研究概览
简要总结
This phase II trial tests whether 68-Gallium prostate specific membrane antigen (68Ga-PSMA) positron emission tomography (PET) imaging can improve the diagnosis and management of liver cancer that has spread to other parts of the body (advanced). PSMA is a protein that appears in large amounts on the surface of liver cancer cells. The radioactive chemical compound (68Ga-PSMA) has been designed to circulate through the body and attach itself to the PSMA protein on liver cancer cells. A PET scan is then used to detect the location of the tumor cells. 68Ga-PSMA PET may improve upon the diagnosis and management of liver cancer.
详细描述
PRIMARY OBJECTIVES:
I. To test the performance of novel biomarkers derived from PSMA PET/computed tomography (CT) to measure response compared to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, in advanced hepatocellular carcinoma (HCC) patients treated with immunotherapy.
II. To identify precision imaging biomarkers that can predict response of HCC to novel immunotherapy.
OUTLINE:
Patients undergo 68GA PSMA PET/CT scans at baseline, and after 3, 6, 9, and 12 cycles of standard of care immunotherapy in the absence of disease progression or unacceptable toxicity.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with pathologically confirmed HCC not amenable to curative resection, transplantation or ablative therapies
- •Have radiographically measurable disease by RECIST
- •Eligible for atezolizumab/bevacizumab front line therapy
- •Male or female with age greater than 18 years, with the capacity and willingness to provide written informed consent
排除标准
- •Pregnant and/or breast-feeding patients. A negative pregnancy test within 48 hours of the PET scan
- •Patients with higher than the weight/size limitations of PET/CT scanner
研究组 & 干预措施
Treatment (68GA PSMA PET/CT)
Patients undergo 68GA PSMA PET/CT scans at baseline, and after 3, 6, 9, and 12 cycles of standard of care immunotherapy in the absence of disease progression or unacceptable toxicity.
干预措施: Computed Tomography (Procedure)
Treatment (68GA PSMA PET/CT)
Patients undergo 68GA PSMA PET/CT scans at baseline, and after 3, 6, 9, and 12 cycles of standard of care immunotherapy in the absence of disease progression or unacceptable toxicity.
干预措施: Gallium Ga 68 Gozetotide (Drug)
Treatment (68GA PSMA PET/CT)
Patients undergo 68GA PSMA PET/CT scans at baseline, and after 3, 6, 9, and 12 cycles of standard of care immunotherapy in the absence of disease progression or unacceptable toxicity.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Time to treatment response
时间窗: Up to 12 cycles of treatment or 36 weeks
Defined as the time from study registration to complete response/partial response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and per PSMA positron emission tomography (PET)/computed tomography (CT).
Progression free survival (PFS) at 6 months
时间窗: At 6 months
Defined as the length of time during and after treatment that a patient lives with cancer without the disease worsening, per RECIST and PSMA PET/CT
Time to progression
时间窗: Up to 3 years
Defined as the time from study registration to disease progression per RECIST 1.1 and PSMA PET/CT.
次要结局
未报告次要终点