The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Hepatobiliary Malignancy

Recruiting

• Conditions: Hepatobiliary Malignancy

• Registration Number: NCT06597539
• Lead Sponsor: Ruijin Hospital

Brief Summary

This study aims to investigate the value of 68Ga-grazytracer in predicting the efficacy of immunotherapy for advanced hepatobiliary malignancies.

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-grazytracer PET/CT after 3 cycles of immunotherapy to evaluate response. The imaging response measurements will be compared with the histopathological or clinical assessment results as gold standard.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Study Start: 2024-11-09
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-11
• Primary Completion: 2026-06-30
• Study Completion: 2027-07-31

Recruitment & Eligibility

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

Inclusion Criteria

1. Pathological and clinical diagnosis of advanced hepatobiliary malignancy requiring immunotherapy or combination immunotherapy after evaluation according to clinical guidelines
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
5. The patient is in good general condition with an expected survival of > 6 months

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. Uncontrolled diabetes patients or fasting blood glucose levels ≥11 mmol/L on the day of the trial
4. Pregnant women and women who may be pregnant, women who are breastfeeding.
5. Non-compliant person

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation the responses to immunotherapy of advanced hepatobiliary malignancy	up to 9 weeks	The value of 68Ga-grazytracer PET in monitoring responses to immunotherapy of advanced hepatobiliary malignancy
Standardized uptake value(SUV)	up to 9 weeks	SUV of 68Ga-grazytracer uptake on PET/CT images for tumor lesions
Target-to-background ratio(TBR)	up to 9 weeks	68Ga-grazytracer uptake ratio of tumor lesions to mediastinum and liver blood pool on PET/CT images.

Secondary Outcome Measures

Name	Time	Method
Progress free survival	1 years	Progress free survival
Overall survival	1 years	Overall survival

Trial Locations

Locations (1)

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