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

NCT06746194 | Recruiting DMC

• 1 other identifier: RuijinH 2024-541
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

hepatocellular carcinoma; 68Ga-FAPI; PET/CT

Outcome Measures

Primary Outcomes (2)

• The responses to systemic antitumor therapy of advanced unresectable hepatocellular carcinoma

  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.

  Within 1 week of enrollment and up to 3 months

• Standardized uptake value(SUV)

  SUV of 68Ga-FAPI uptake on PET/CT images for tumor lesions

  Within 1 week of enrollment and after up to 3 months

Secondary Outcomes (2)

• Progress free survival

  3 years

• Overall survival

  3 years

Study Arms (1)

Patients diagnosis of advanced unresectable hepatocellular carcinoma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Jiajia Hu

CONTACT

13524945287; jiajiahu@shsmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 24, 2024
• Study Start: December 3, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)