Hepatocellular carcinoma
Conditions
Interventions
Hepatocellular carcinoma PET/CT imaging group:BPR8009 injection, BPR8000 injection
Sponsors
The First Affiliated Hospital, Jinan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the research and sign the informed consent form. 2. Age: 18 years or above, Gender: Open to all; 3. For patients who have already been clearly diagnosed with hepatocellular carcinoma. 4. Because PET/CT examinations are necessary for diagnosis, structure assessment, location evaluation, functional assessment and disease management, there must be at least one relatively large measurable (confirmed by enhanced CT and/or MRI) metastatic lesion. 5. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 to 2. 6. Expected survival period >= 3 months; 7. The subjects must have appropriate organ functions: • Bone marrow reserve: White blood cell count (WBC) >= 3.0×10^9/L or neutrophil count (ANC) >= 1.5×10^9/L; platelet count (PLT) >= 90×10^9/L; hemoglobin (HGB) >= 80 g/L; • Liver function: Total bilirubin (TBIL) = 50 ml/min (calculated according to the Cockcroft-Gault formula); • Coagulation function: Prothrombin time (PT), activated partial thromboplastin time (APTT) < 1.5 times ULN; 8. For women of childbearing age, the blood pregnancy test must be negative within 7 days prior to the first use of the investigational drug, and they must not be breastfeeding. Qualified patients (both male and female) with reproductive capacity must agree to use a reliable contraceptive method (hormonal, barrier, or abstinence) with their partners for at least 6 months from the date of signing the informed consent form until the last administration of the study drug. Infertile women may not undergo pregnancy testing or use contraception (menopause for at least 1 year or surgically sterilized). 9. Willing and able to comply with all research requirements and cooperate with research visits.
Exclusion criteria
Exclusion criteria: 1. Within 28 days prior to the planned administration of the investigational drug injection, the use of targeted GPC-3 drugs has occurred, including but not limited to CAR-T/NK, therapeutic vaccines, antibodies, ADCs, conjugated nuclides, CRISPR/Cas9, etc. 2. Individuals who have received a cumulative radiation dose of = 50 mSv within the past 1 year (inquiries were made regarding previous radiation therapy and radiological examinations within the past year, and these details were recorded in the screening medical records); 3. Those who have undergone radioactive particle implantation within the past 6 months and whose condition, as assessed by the researchers, still poses an impact on current imaging examinations. 4. Have severe or poorly controlled systemic diseases, such as congestive heart failure; unstable angina pectoris; myocardial infarction that occurred within 6 months before the administration of the study drug; refractory hypertension; acute kidney injury; uncontrolled diabetes; uncontrolled autoimmune diseases; stroke; severe liver damage; arterial-venous thrombosis requiring anticoagulant therapy; epilepsy that still has seizures within the last 6 months; asthma that still has seizures within the last 3 months; persistent fever above 38.5? or active infections that require intravenous medication treatment, etc. 5. Combined brain metastasis, meningeal metastasis, spinal cord compression or soft meningeal disorders (excluding those who have not used corticosteroids, anticonvulsants, or diuretics to control symptoms in the last 2 weeks, or those without neurological symptoms); 6. Those who are unable to complete the imaging examinations as required by the plan, including those who are unwilling to undergo imaging tests due to claustrophobia, radiation phobia, or personal preference, those who cannot maintain a relatively still position or the required posture during the imaging process due to coughing, arthritis, etc., those who cannot undergo the examination due to exceeding the applicable range of the examination equipment, having a pacemaker implanted or having metal objects that are difficult to remove, etc. 7. It is planned that during the study period, the subject will still need to receive any anti-tumor treatment, and these treatments cannot be clearly excluded from potentially affecting the evaluation of the test drug. 8. It is known that one is allergic to any research drug, its excipients, or drugs belonging to similar chemical categories, or has experienced an allergic reaction or intolerance. 9. Having participated in any other clinical trials or received experimental drugs within the previous 28 days before enrollment; 10. Other situations that the researcher deems unsuitable for participation in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lesion SUV value; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety; | — |
Countries
China
Contacts
Public ContactWang Lu
The First Affiliated Hospital, Jinan University
Outcome results
None listed