FAPI PET for Response Evaluation and Prognosis Prediction in Liver and Biliary Cancer Patients Treated With PD-1 Combination Therapy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Baseline SUVmax on [68Ga]FAPI and [18F] FDG PET Scans [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 [through study completion, an average of 2 years]
Baseline fibro-activation tumor volume and metabolic tumor volume before treatment were determined.
- Baseline total lesion activation on [68Ga]FAPI and [18F] FDG PET Scans [through study completion, an average of 2 years]
Baseline total lesion fibro-activation and total lesion glycolysis before treatment were determined.
- Response of SUVmax to anti-PD1-based combination therapy shown in [68Ga]FAPI and [18F] FDG PET Scans [through study completion, an average of 1 years]
Changes in FAPI and FDG SUVmax during treatment were determined.
- Response of active tumor volume to anti-PD1-based combination therapy shown in [68Ga]FAPI and [18F] FDG PET Scans [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 [through study completion, an average of 1 years]
Changes in total lesion fibro-activation and total lesion glycolysis during treatment were determined.
Secondary Outcome Measures
- Tumor response evaluated by CT and MRI [through study completion, an average of 1 years]
Tumor response was reported per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Overall survival after treatment [through study completion, an average of 2 years]
Overall survival after treatment
- Progression-free survival after treatment [through study completion, an average of 2 years]
Progression-free survival after treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
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locally advanced or metastatic and/or unresectable HCC or BTC
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Child Pugh A or B liver function status
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an ECOG performance status score of 0-2
Exclusion Criteria:
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intolerance to anti-PD-1-based combination therapy
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active or prior autoimmune disease
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concurrent use of immunosuppressive medicaments
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Nuclear Medicine, Peking Union Medical College Hopital | Beijing | China | 100730 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
- Principal Investigator: Li Huo, Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PekingUMCH-FAPI-LBC-RESPONSE