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NCT Number: NCT06746194

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

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.

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Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Haiguang xin

CONTACT

[email protected]

18221888838

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The responses to systemic antitumor therapy of advanced unresectable hepatocellular carcinoma

    Time frame: 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.

  2. Standardized uptake value(SUV)

    Time frame: Within 1 week of enrollment and after up to 3 months

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

Secondary outcomes

  1. Progress free survival

    Time frame: 3 years

    Progress free survival

  2. Overall survival

    Time frame: 3 years

    Overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Jiajia Hu

CONTACT

[email protected]

13524945287

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 24, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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