The Value of 68Ga-FAPI PET/CT in the Efficacy Evaluation of Advanced Unresectable Hepatocellular Carcinoma Patients Undergoing Systemic Antitumor Therapy

Recruiting

• Conditions: Hepatocellular Carcinoma (HCC)

• Registration Number: NCT06746194
• Lead Sponsor: Ruijin Hospital

Brief Summary

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.

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-03
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Pathological and clinical diagnosis of advanced unresectable hepatocellular carcinoma patients.
2. Signed and dated informed consent form.
3. Commitment to comply with research procedures and co-operation in the implementation of the full research process.
4. Aged 18-75 years old.

Exclusion Criteria

1. 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.
2. Intestinal perforation, complete intestinal obstruction
3. Pregnant women and women who may be pregnant, women who are breastfeeding.
4. Non-compliant person

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The responses to systemic antitumor therapy of advanced unresectable hepatocellular carcinoma	Within 1 week of enrollment and up to 3 months	The tumor lesions were evaluated within one week of enrollment and at 3 months of treatment, and a comparison was made before and after. Those with improved tumor lesions were considered to have responded to the treatment, while those without improved tumor lesions were considered to have no response to the treatment.
Standardized uptake value(SUV)	Within 1 week of enrollment and after up to 3 months	SUV of 68Ga-FAPI uptake on PET/CT images for tumor lesions

Secondary Outcome Measures

Name	Time	Method
Progress free survival	3 years	Progress free survival
Overall survival	3 years	Overall survival

Trial Locations

Locations (1)

Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine; 🇨🇳 Shanghai, Shanghai, China