FAPI PET for Response Evaluation and Prognosis Prediction in Liver and Biliary Cancer Patients Treated With PD-1 Combination Therapy

December 14, 2022 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Diagnostic test: [68Ga]FAPI PET/CT and [18F]FDG PET/CT

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

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- - Beijing, China, 100730
    - Department of Nuclear Medicine, Peking Union Medical College Hopital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Advanced HCC or BTC patients who accept PD1-based combination therapy

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.	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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

Principal Investigator: Li Huo, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

August 30, 2022

Study Completion (Anticipated)

August 30, 2023

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Estimate)

December 22, 2022

Study Record Updates

Last Update Posted (Estimate)