The Value of 68Ga-FAPI PET/CT in the Efficacy Evaluation of Advanced Unresectable Hepatocellular Carcinoma Patients Undergoing Systemic Antitumor Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma (HCC). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study aims to investigate the value of 68Ga-FAPI PET/CT in the efficacy evaluation of advanced unresectable hepatocellular carcinoma patients undergoing systemic antitumor therapy.
Detailed description
The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-FAPI PET/CT before treatment and after 3-month treatment. The imaging response measurements will be compared with the histopathological results as gold standard.
Primary outcome measures
- The responses to systemic antitumor therapy of advanced unresectable hepatocellular carcinoma [Time frame: Within 1 week of enrollment and up to 3 months]
- Standardized uptake value(SUV) [Time frame: Within 1 week of enrollment and after up to 3 months]
Secondary outcome measures (2)
- Progress free survival [Time frame: 3 years]
- Overall survival [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Pathological and clinical diagnosis of advanced unresectable hepatocellular carcinoma patients.
- Signed and dated informed consent form.
- Commitment to comply with research procedures and co-operation in the implementation of the full research process.
- Aged 18-75 years old.
Exclusion criteria
- Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
- Intestinal perforation, complete intestinal obstruction
- Pregnant women and women who may be pregnant, women who are breastfeeding.
- Non-compliant person
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine — Shanghai
Identifiers
NCT: NCT06746194 · RuijinH 2024-541