FAPI PET for Response Evaluation and Prognosis Prediction in Liver and Biliary Cancer Patients Treated With PD-1 Combination Therapy
- Conditions
- Hepatocellular CarcinomaBile Duct Cancer
- Registration Number
- NCT05662488
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 25
- 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
- intolerance to anti-PD-1-based combination therapy
- active or prior autoimmune disease
- concurrent use of immunosuppressive medicaments
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
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.
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 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
Name Time Method Progression-free survival after treatment through study completion, an average of 2 years Progression-free survival after treatment
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
Trial Locations
- Locations (1)
Department of Nuclear Medicine, Peking Union Medical College Hopital
🇨🇳Beijing, China