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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]FAPI PET/CT and [18F]FDG PET/CT | Diagnostic Test | To perform [68Ga]FAPI PET/CT and [18F]FDG PET/CT in patients with advanced liver and biliary cancer before and after treatment with PD-1 Based Combination Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline SUVmax on [68Ga]FAPI and [18F] FDG PET Scans | Baseline FAPI and FDG SUVmax, fibro-activation tumor volume (metabolic tumor volume), total lesion fibro-activation (total lesion glycolysis) before treatment were determined. | through study completion, an average of 2 years |
| Baseline active tumor volume on [68Ga]FAPI and [18F] FDG PET Scans | Baseline fibro-activation tumor volume and metabolic tumor volume before treatment were determined. | through study completion, an average of 2 years |
| Baseline total lesion activation on [68Ga]FAPI and [18F] FDG PET Scans | Baseline total lesion fibro-activation and total lesion glycolysis before treatment were determined. | through study completion, an average of 2 years |
| Response of SUVmax to anti-PD1-based combination therapy shown in [68Ga]FAPI and [18F] FDG PET Scans | Changes in FAPI and FDG SUVmax during treatment were determined. | through study completion, an average of 1 years |
| Response of active tumor volume to anti-PD1-based combination therapy shown in [68Ga]FAPI and [18F] FDG PET Scans | Changes in fibro-activation tumor volume and metabolic tumor volume during treatment were determined. | through study completion, an average of 1 years |
| Response of total lesion activation to anti-PD1-based combination therapy shown in [68Ga]FAPI and [18F] FDG PET Scans | Changes in total lesion fibro-activation and total lesion glycolysis during treatment were determined. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response evaluated by CT and MRI | Tumor response was reported per Response Evaluation Criteria in Solid Tumors (RECIST) criteria | through study completion, an average of 1 years |
| Overall survival after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Advanced HCC or BTC patients who accept PD1-based combination therapy
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| Name | Affiliation | Role |
|---|---|---|
| Li Huo | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nuclear Medicine, Peking Union Medical College Hopital | Beijing | 100730 | China |
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| through study completion, an average of 1 years |
Overall survival after treatment
| through study completion, an average of 2 years |
| Progression-free survival after treatment | Progression-free survival after treatment | through study completion, an average of 2 years |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D001650 | Bile Duct Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
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