The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Hepatobiliary Malignancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hepatobiliary Malignancy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Study on Investigating the Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Hepatobiliary Malignancy
Overview
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.
Primary outcome measures
- Evaluation the responses to immunotherapy of advanced hepatobiliary malignancy [Time frame: up to 9 weeks]
- Standardized uptake value(SUV) [Time frame: up to 9 weeks]
- Target-to-background ratio(TBR) [Time frame: up to 9 weeks]
Secondary outcome measures (2)
- Progress free survival [Time frame: 1 years]
- Overall survival [Time frame: 1 years]
Eligibility criteria
Inclusion criteria
- Pathological and clinical diagnosis of advanced hepatobiliary malignancy requiring immunotherapy or combination immunotherapy after evaluation according to clinical guidelines
- 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
- The patient is in good general condition with an expected survival of \> 6 months
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
- Uncontrolled diabetes patients or fasting blood glucose levels ≥11 mmol/L on the day of the trial
- Pregnant women and women who may be pregnant, women who are breastfeeding.
- Non-compliant person
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine — Shanghai
Identifiers
NCT: NCT06597539 · RuijinH 2024-232