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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2023-08-30

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma Bile Duct Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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[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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Huo

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Department of Nuclear Medicine, Peking Union Medical College Hopital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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PekingUMCH-FAPI-LBC-RESPONSE

Identifier Type: -

Identifier Source: org_study_id