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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05662488
• Other study ID #: PekingUMCH-FAPI-LBC-RESPONSE
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Bile Duct Cancer
• Bile Duct Neoplasms
• Cholangiocarcinoma
• Hepatocellular Carcinoma

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