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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Hepatobiliary Malignancy

Study type: Observational

Funder types: Other

Identifiers

NCT06597539

RuijinH 2024-232

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Diagnosis of advanced hepatobiliary malignancies

Description:

Patients diagnosis of advanced hepatobiliary malignancies require immunotherapy or combination immunotherapy after evaluation according to clinical guidelines