Bone and soft tissue sarcoma
Conditions
Interventions
TROP2-targeted therapy group:Ruxolitinib monoclonal antibody for injection
DR5 agonist group:Ephedrine for injection
Bcl-2 inhibitor group:Risedronate
Nectin4-targeted therapy group:Injection of Veentoyu Monoclonal Antibody
HER-2 targeted therapy group:Trastuzumab deruxtecan
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
3 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1) Age >=3 years, any gender; 2) ECOG performance status 0-2; 3) Expected survival >=3 months; 4) Histologically confirmed unresectable locally advanced or metastatic osteosarcoma or soft tissue sarcoma; 5) Patients who have failed at least one line of treatment, including those whose disease progressed during or within 6 months after neoadjuvant or adjuvant therapy; 6) At least one measurable lesion according to RECIST 1.1 criteria; 7) Tumor tissue confirmed by immunohistochemistry or molecular testing to express relevant targets (TROP2, DR5, Bcl-2, Nectin4, and Her-2), with different treatments determined by different molecular expression levels; Cohort 1: TROP2 positive; Cohort 2: DR5 positive; Cohort 3: Bcl-2 positive; Cohort 4: Nectin4 positive; Cohort 5: Her-2 positive (or FISH amplification positive); 8) Normal major organ and bone marrow function, meeting the following requirements: a. Hemoglobin >=90 g/L (no blood transfusion within 14 days); b. Absolute neutrophil count >=1.5*10^9/L; c. Platelet count >=90*10^9/L; d. Total bilirubin =50%; QTc <450 ms for males and <470 ms for females; 9) For patients who have never received anticoagulant therapy, prothrombin time international normalized ratio (INR) <=1.5, activated partial thromboplastin time (APTT) <=1.5 times ULN. For patients on full-dose or parenteral anticoagulants, the dose must have been stable for at least 2 weeks prior to study entry, and coagulation test results must be within the local institution's acceptable range; 10) Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and agree to use appropriate contraception during the study and for 3 months after the last dose of study drug; for men, they must be surgically sterile or agree to use appropriate contraception during the study and for 3 months after the last dose of study drug; 11) Recovery from prior treatments: according to NCI-CTC AE version 5.0, prior treatment-related toxicities must have resolved to <= grade 2 (if surgery was performed, wounds must be fully healed); 12) Patients must voluntarily participate and sign informed consent (or legal representative if applicable), demonstrate expected compliance, and be able to adhere to study procedures, showing that they understand the study objectives and requirements and are willing to participate. Subjects under 18 years of age must sign a minor’s informed consent form.
Exclusion criteria
Exclusion criteria: Potential participants meeting any of the following criteria must be excluded from the study: 1) Within 3 weeks after the last systemic cytotoxic drug treatment, radiotherapy, or any investigational drug treatment; 2) Active central nervous system metastases; 3) Severe cardiovascular disease, including myocardial infarction within 6 months prior to enrollment, New York Heart Association class II or higher heart failure, uncontrolled angina, uncontrolled severe ventricular arrhythmias, clinically significant pericardial disease, or electrocardiogram indicating acute ischemia or active conduction system abnormalities; 4) Ongoing active infection, or psychiatric disorders or social conditions that may affect the participant’s compliance with the investigator; 5) Pregnant or breastfeeding patients, or patients of reproductive potential unwilling to use effective contraception; 6) Any condition that the investigator believes may harm the participant or prevent them from meeting or complying with study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Overall survival;Quality of Life Score; | — |
Countries
China
Contacts
Public ContactHaiyan Hu
Shanghai Sixth People's Hospital
Outcome results
None listed