Solid tumor with bone metastasis
Conditions
Interventions
experimental group:177Lu-FAP-2286 combined with 177Lu-TBM-001
Sponsors
The affiliated hospital of southwest medical university
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) The patient is able to understand and voluntarily sign an approved informed consent form (ICF); 2) Age >= 18 years old, male or female not limited; 3) Solid tumor with bone metastasis patients: Suspected or diagnosed patients with bone metastasis, and positive 68Ga FAP and 68Ga TBM PET/CT imaging before treatment (positive usually indicates higher uptake of imaging agent by the lesion than normal bone); 4) Solid tumors must have at least one measurable bone metastasis target lesion according to RECIST 1.1 criteria; 5) Expected survival period>6 months; 6) ECOG score = 2.5 * 10^9/L ; (2) Platelets >= 100 * 10^9/L; (3) Hemoglobin >= 90g/dL; (4)Total bilirubin = 50mL/min; 8) All other existing toxicity levels must be <= NCI-CTCAE v5.0 Grade 0 or Grade 1; 9).Women must use effective contraceptive measures during the study period and within 6 months after the end of the study (effective contraceptive measures refer to sterilization, intrauterine hormone devices, condoms, birth control pills/doses, abstinence, or partner vas deferens removal, etc.); Male participants must agree to use contraception during the study period and within 6 months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1) Patients who have received nuclear therapy within 6 months; 2) Patients who receive chemotherapy, radiotherapy, immunotherapy, or clinical trial drug treatment within 28 days; 3) There are any of the following conditions: brain metastasis (excluding asymptomatic and untreated metastatic brain tumors), cancerous cerebrospinal meningitis, myocardial infarction (within 6 months before enrollment), unstable angina, or a high risk of uncontrollable arrhythmia, coronary artery bypass grafting, cerebrovascular accident (within 6 months before enrollment), congestive heart failure (heart function grade III-IV), pulmonary embolism, deep vein thrombosis, infections requiring intravenous antibiotic treatment within 2 weeks, and immunosuppressive therapy after organ transplantation; 4) HBV DNA copy number >= 10 ^ 4 or >= 2000IU/ml;(1).HCV-RNA >= 1000 copy numbers/ml;(2).AIDS virus antibody or syphilis antibody positive; 5) Individuals with a history of acute or subacute intestinal obstruction, or inflammatory bowel disease; 6) Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders; 7) Allergic constitution, or those who are allergic to known research drug ingredients or excipients; 8) Those who cannot lie flat for half an hour to undergo PET/CT or SPECT/CT examinations; 9) Suffering from claustrophobia or unable to tolerate imaging operators for other reasons; 10) Family planning within 6 months; 11) Subjects with poor compliance and expected inability to cooperate in completing the trial procedure; 12).Researchers believe that other participants who are not suitable to participate in clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiation Dosimetry: Collect biodistribution and radiation dose data for the whole body and major tissues/organs at various time points after drug administration;The incidence and severity of adverse events (AEs), serious adverse events (SAEs), and clinically significant abnormal laboratory test results, among other factors; | — |
Secondary
| Measure | Time frame |
|---|---|
| NRS score;KPS Score;ECOG Score; | — |
Countries
China
Contacts
Public ContactChen Yue
The affiliated hospital of southwest medical university
Outcome results
None listed