Bile Duct Cancer, Hepatocellular Carcinoma
Conditions
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.
Interventions
DIAGNOSTIC_TEST[68Ga]FAPI PET/CT and [18F]FDG PET/CT
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
Sponsors
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* intolerance to anti-PD-1-based combination therapy * active or prior autoimmune disease * concurrent use of immunosuppressive medicaments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
China
Outcome results
None listed