Clinical trial NCT05662488: FAPI PET for Response Evaluation and Prognosis Prediction in Liver and Biliary Cancer Patients Treated With PD-1 Combination Therapy
Official title: 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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Bile Duct Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Advanced HCC or BTC patients who accept PD1-based combination therapy

Brief 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.

Eligibility 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

Primary outcomes:
measure: Baseline SUVmax on [68Ga]FAPI and [18F] FDG PET Scans
timeFrame: through study completion, an average of 2 years
measure: Baseline active tumor volume on [68Ga]FAPI and [18F] FDG PET Scans
timeFrame: through study completion, an average of 2 years
measure: Baseline total lesion activation on [68Ga]FAPI and [18F] FDG PET Scans
timeFrame: through study completion, an average of 2 years
measure: Response of SUVmax to anti-PD1-based combination therapy shown in [68Ga]FAPI and [18F] FDG PET Scans
timeFrame: through study completion, an average of 1 years
measure: Response of active tumor volume to anti-PD1-based combination therapy shown in [68Ga]FAPI and [18F] FDG PET Scans
timeFrame: through study completion, an average of 1 years
measure: Response of total lesion activation to anti-PD1-based combination therapy shown in [68Ga]FAPI and [18F] FDG PET Scans
timeFrame: through study completion, an average of 1 years
Secondary outcomes:
measure: Tumor response evaluated by CT and MRI
timeFrame: through study completion, an average of 1 years
measure: Overall survival after treatment
timeFrame: through study completion, an average of 2 years
measure: Progression-free survival after treatment
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Nuclear Medicine, Peking Union Medical College Hopital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Li Huo
role: PRINCIPAL_INVESTIGATOR
References: