Hepatocellular CarcinomaNCT05662488
FAPI PET for Response Evaluation and Prognosis Prediction in Liver and Biliary Cancer Patients Treated With PD-1 Combination Therapy
An observational study of Hepatocellular Carcinoma and Bile Duct Cancer, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hepatocellular Carcinoma, Bile Duct Cancer
- What is being tested?
- [68Ga]FAPI PET/CT and [18F]FDG PET/CT
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced HCC or BTC patients who accept PD1-based combination therapy
Who may be able to join
- 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
Who cannot join
- intolerance to anti-PD-1-based combination therapy
- active or prior autoimmune disease
- concurrent use of immunosuppressive medicaments
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nuclear Medicine, Peking Union Medical College Hopital
Beijing, 100730
About this study
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
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma, Bile Duct Cancer
- Being tested
- [68Ga]FAPI PET/CT and [18F]FDG PET/CT
- Medical subject headings
- Carcinoma, Hepatocellular, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]FAPI PET/CT and [18F]FDG PET/CTDiagnostic test
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 2 years
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.
Measured: through study completion, an average of 2 years
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.
Measured: 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
Changes in FAPI and FDG SUVmax during treatment were determined.
Measured: 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
Changes in fibro-activation tumor volume and metabolic tumor volume during treatment were determined.
Measured: 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
Changes in total lesion fibro-activation and total lesion glycolysis during treatment were determined.
Measured: through study completion, an average of 1 years
Secondary outcomes (3)
Tumor response evaluated by CT and MRI
Tumor response was reported per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Measured: through study completion, an average of 1 years
Overall survival after treatment
Overall survival after treatment
Measured: through study completion, an average of 2 years
Progression-free survival after treatment
Progression-free survival after treatment
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Sep 2020
- Primary completion30 Aug 2022
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Huo, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662488
- Sponsor's protocol ID
- PekingUMCH-FAPI-LBC-RESPONSE
- Status last verified
- Dec 2022
- First submitted
- 5 Dec 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05662488
- Acronym / sponsor ID
- PekingUMCH-FAPI-LBC-RESPONSE
- Conditions
- Hepatocellular Carcinoma, Bile Duct Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced HCC or BTC patients who accept PD1-based combination therapy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- intolerance to anti-PD-1-based combination therapy
- active or prior autoimmune disease
- concurrent use of immunosuppressive medicaments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]FAPI PET/CT and [18F]FDG PET/CTTo 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 | Diagnostic test | – |
Primary outcome
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Tumor response evaluated by CT and MRI
Time frame: through study completion, an average of 1 years
Overall survival after treatment
Time frame: through study completion, an average of 2 years
Progression-free survival after treatment
Time frame: through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Huo principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Bile Duct Cancer, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline SUVmax on [68Ga]FAPI and [18F] FDG PET Scans (time frame: through study completion, an average of 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.