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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05662488
Other study ID # PekingUMCH-FAPI-LBC-RESPONSE
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date August 30, 2023

Study information

Verified date December 2022
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Active, not recruiting
Enrollment 25
Est. completion date August 30, 2023
Est. primary completion date August 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
China Department of Nuclear Medicine, Peking Union Medical College Hopital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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. through study completion, an average of 1 years
Secondary 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
Secondary Overall survival after treatment Overall survival after treatment through study completion, an average of 2 years
Secondary Progression-free survival after treatment Progression-free survival after treatment through study completion, an average of 2 years
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