Advanced osteosarcoma, Ewing's sarcoma, chordoma and chondrosarcoma
Conditions
Interventions
Part A group:VG161
Experimental group:VG161+apatinib
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 70 years old (inclusive), no gender restrictions; 2. Patients with advanced osteosarcoma, Ewing's sarcoma, chordoma and chondrosarcoma confirmed by histology or cytology, unresectable or postoperative recurrence, and who have failed at least one standard treatment; 3. There are tumor lesions that meet the volume requirements for VG161 injection (tumor volume > 5cm), including superficial lesions or deep lesions that can be injected under ultrasound guidance (the injection lesions are preferably the main tumor burden lesions, and those that can be injected For selection, please refer to the route of administration and method of use); 4. ECOG physical fitness score 0-1 points; 5. The expected survival time is more than 3 months; 6. Sufficient organ function: routine blood test (no blood transfusion or colony-stimulating factor treatment within 14 days): ANC>=1.5x10^9/L, PLT>=75x10^9/L, Hb>=85g/L ; Liver function: TBIL=45ml/min (calculated according to Cockcroft-Gault formula); coagulation function: activated partial thromboplastin time (APTT) <=1.5xULN, international normalized ratio (INR) <=1.5xULN; 7. Eligible subjects (male and female) of childbearing potential must agree to use reliable contraceptive methods (hormonal or barrier method or abstinence) during the trial and for at least 90 days after the last dose; female patients of childbearing age before enrollment 7 A blood pregnancy test within days must be negative; 8. Subjects must give informed consent to this study before the test, and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy (including VEGFR inhibitor drugs), immunotherapy and other anti-tumor drugs within 4 weeks before the first use of the study drug, among which oral fluorouracil and small molecule Targeted drugs are 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever is longer); 2. Received other unmarketed clinical trial treatments within 4 weeks before the first use of the study drug; 3. Received major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before the first use of the study drug; 4. Patients who have received systemic corticosteroids (prednisone>10mg/day or equivalent doses of similar drugs) or other immunosuppressive therapy within 14 days before the first use of the study drug; Except for the following: treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term corticosteroids for prophylaxis (eg, prophylaxis of contrast media allergy); 5. The adverse reactions of previous anti-tumor therapy have not recovered to CTCAE 5.0 grade evaluation <= grade 1 (except for toxicities such as alopecia that the researchers judged to have no safety risk); 6. Associated with central nervous system metastasis or meningeal metastasis, which is judged by the investigator to be unsuitable for inclusion; 7. The test results of herpes simplex virus type I antibody (HSV-1 IgG and HSV-1 IgM) are all negative; 8. In the recurrent infection period of herpes simplex virus, and there are corresponding clinical manifestations, such as herpes labialis, herpetic keratitis, herpetic dermatitis, genital herpes, etc.; 9. Other uncontrolled active infections; 10. Have a history of immunodeficiency, including positive HIV antibody test; 11. Active hepatitis B (hepatitis B virus titer above the lower limit of detection), or hepatitis C virus (HCV) infection.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;overall survival;Quality of life score; | — |
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Countries
China
Contacts
Public ContactYang Xinghai
Shanghai Changzheng Hospital
Outcome results
None listed