Hepatobiliary Malignancy
Conditions
Keywords
68Ga-grazytracer PET/CT, Immunotherapy, Advanced hepatobiliary malignancy
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.
Interventions
None listed
Sponsors
Ruijin Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Progress free survival | 1 years | Progress free survival |
| Overall survival | 1 years | Overall survival |
Countries
China
Contacts
Primary ContactJiajia Hu
Outcome results
None listed