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Trial Title:
FAPI PET for Response Evaluation and Prognosis Prediction in Liver and Biliary Cancer Patients Treated With PD-1 Combination Therapy
NCT ID:
NCT05662488
Condition:
Hepatocellular Carcinoma
Bile Duct Cancer
Conditions: Official terms:
Bile Duct Neoplasms
Cholangiocarcinoma
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
[68Ga]FAPI PET/CT and [18F]FDG PET/CT
Description:
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
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.
Criteria for eligibility:
Study pop:
Advanced HCC or BTC patients who accept PD1-based combination therapy
Sampling method:
Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Nuclear Medicine, Peking Union Medical College Hopital
Address:
City:
Beijing
Zip:
100730
Country:
China
Start date:
September 1, 2020
Completion date:
August 30, 2023
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05662488
