68Ga-FAPI PET for Response Evaluation and Prognosis Prediction in Advanced Liver and Biliary Cancer Patients Treated With PD-1 Based Combination Therapy: A Head-to-head Comparison to 18F-FDG PET
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Baseline SUVmax on [68Ga]FAPI and [18F] FDG PET Scans
研究概览
简要总结
The purpose of this study is to explore the ability of positron emission tomography (PET) with [68Ga]FAPI to detect, evaluate treatment response, and predict prognosis in advanced liver and biliary cancer patients treated with anti-PD-1 antibodies-based combination therapy.
详细描述
Hepatocellular carcinoma (HCC) and bile tract cancers (BTC) are major health issue worldwide, particularly in Eastern Asia. Anti-PD-1 antibodies-based combination therapy has shown considerable efficacy in advanced HCC and BTC. However, an objective response is only achieved in a portion of patients. Thus, there is an urgent need for better patient selection before immunotherapy as well as accurate evaluation of treatment response.
PET is a noninvasive imaging technique which might be an effective tool for evaluating anti-PD-1 antibody-based combination treatment in liver and biliary cancer. 68Ga-FAPI has been developed as a novel agent targeting fibroblast activation protein (FAP) that is overexpressed in cancer-associated fibroblasts in liver and biliary cancer. Prior studies have shown that FAP-expressing CAF suppresses anti-tumor immunity while suppressing FAP can overcome stromal barriers to immuno-oncological responses. Meanwhile, 68Ga-FAPI PET showed a high detection rate in primary and metastatic lesions in liver and biliary cancer. The aim of this study is to evaluate the ability of positron emission tomography (PET) with [68Ga]FAPI to detect, evaluate treatment response, and predict prognosis in advanced liver and biliary cancer patients treated with anti-PD-1 antibodies-based combination therapy. Our hypothesis is that baseline [68Ga]FAPI PET parameters can predict response and clinical benefit of anti-PD-1 antibodies-based combination therapy and overall survival; that effects of anti-PD-1 antibodies-based combination therapy in liver and biliary cancer can be detected and quantified by [68Ga]FAPI PET after treatment in correlation with other radiological findings and clinical endpoints; that such effects are more prominent with [68Ga]FAPI PET than with the traditional [18F]FDG PET.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •locally advanced or metastatic and/or unresectable HCC or BTC
- •Child Pugh A or B liver function status
- •an ECOG performance status score of 0-2
排除标准
- •intolerance to anti-PD-1-based combination therapy
- •active or prior autoimmune disease
- •concurrent use of immunosuppressive medicaments
结局指标
主要结局
Baseline SUVmax on [68Ga]FAPI and [18F] FDG PET Scans
时间窗: through study completion, an average of 2 years
Baseline FAPI and FDG SUVmax, fibro-activation tumor volume (metabolic tumor volume), total lesion fibro-activation (total lesion glycolysis) before treatment were determined.
Baseline active tumor volume on [68Ga]FAPI and [18F] FDG PET Scans
时间窗: through study completion, an average of 2 years
Baseline fibro-activation tumor volume and metabolic tumor volume before treatment were determined.
Response of SUVmax to anti-PD1-based combination therapy shown in [68Ga]FAPI and [18F] FDG PET Scans
时间窗: through study completion, an average of 1 years
Changes in FAPI and FDG SUVmax during treatment were determined.
Baseline total lesion activation on [68Ga]FAPI and [18F] FDG PET Scans
时间窗: through study completion, an average of 2 years
Baseline total lesion fibro-activation and total lesion glycolysis before treatment were determined.
Response of active tumor volume to anti-PD1-based combination therapy shown in [68Ga]FAPI and [18F] FDG PET Scans
时间窗: through study completion, an average of 1 years
Changes in fibro-activation tumor volume and metabolic tumor volume during treatment were determined.
Response of total lesion activation to anti-PD1-based combination therapy shown in [68Ga]FAPI and [18F] FDG PET Scans
时间窗: through study completion, an average of 1 years
Changes in total lesion fibro-activation and total lesion glycolysis during treatment were determined.
次要结局
- Progression-free survival after treatment(through study completion, an average of 2 years)
- Tumor response evaluated by CT and MRI(through study completion, an average of 1 years)
- Overall survival after treatment(through study completion, an average of 2 years)