- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05662488
FAPI PET for Response Evaluation and Prognosis Prediction in Liver and Biliary Cancer Patients Treated With PD-1 Combination Therapy
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing, China, 100730
- Department of Nuclear Medicine, Peking Union Medical College Hopital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline SUVmax on [68Ga]FAPI and [18F] FDG PET Scans
Time Frame: 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.
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through study completion, an average of 2 years
|
Baseline active tumor volume on [68Ga]FAPI and [18F] FDG PET Scans
Time Frame: through study completion, an average of 2 years
|
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
Time Frame: through study completion, an average of 2 years
|
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
Time Frame: through study completion, an average of 1 years
|
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
Time Frame: through study completion, an average of 1 years
|
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
Time Frame: through study completion, an average of 1 years
|
Changes in total lesion fibro-activation and total lesion glycolysis during treatment were determined.
|
through study completion, an average of 1 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor response evaluated by CT and MRI
Time Frame: through study completion, an average of 1 years
|
Tumor response was reported per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
|
through study completion, an average of 1 years
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Overall survival after treatment
Time Frame: through study completion, an average of 2 years
|
Overall survival after treatment
|
through study completion, an average of 2 years
|
Progression-free survival after treatment
Time Frame: through study completion, an average of 2 years
|
Progression-free survival after treatment
|
through study completion, an average of 2 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Li Huo, Peking Union Medical College Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PekingUMCH-FAPI-LBC-RESPONSE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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