Osteosarcoma
Conditions
Interventions
Case series:PD-1 combined with oncolytic virus and chemotherapy
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects who volunteered to join the study signed the informed consent form, which showed good compliance and cooperated with the follow-up; 2. Subjects aged over 12 years, regardless of gender; 3. Patients with primary metastatic osteosarcoma (ennecking stage III) diagnosed by histopathology and imaging; 4. Patients must have at least one injectable lesion, and the lesion must meet RECIST 1.1 and irecast measurable target lesions; 5. Subjects with ECoG score of 0-1; 6. Patients with an expected survival time of more than 3 months; 7. Patients who voluntarily sign informed consent form; 8. Laboratory examination must meet the following standards: neutrophil absolute value >=1.5x10^9/L; platelet count >=100x10^9/L; hemoglobin >=90 g/L; serum albumin >=28 g/L; total bilirubin =60 ml/min (application standard) The left ventricular ejection fraction (LVEF) >=50%; 9. Women of childbearing age were required to take effective contraceptive methods during the study period and within 3 months after the end of the study treatment period; the serum or urine HCG test of non-surgical sterilized women of childbearing age must be negative within 7 days before study enrollment. Male patients and their partners must agree to use effective contraception during the study.
Exclusion criteria
Exclusion criteria: 1. Patients with non primary osteosarcoma and patients with brain metastases; 2. Patients with active autoimmune diseases or history of autoimmune diseases (such as, but not limited to, interstitial pneumonia, uveitis, colitis, hepatitis, arthritis, nephritis, hypophysitis, hyperthyroidism, hypothyroidism, etc.); but not including autoimmune mediated thyroid function treated with stable dose of thyroid replacement hormone Patients with vitiligo or recovered childhood asthma / allergy who do not need medical intervention in adulthood; 3. The subjects were using immunosuppressant, systemic or absorbable local corticosteroids to achieve the purpose of immunosuppression (prednisone dose > 10mg / day or equivalent) and continued to use them within 2 weeks before enrollment; 4. Patients who have received any form of organ transplantation, including allogeneic stem cell transplantation; 5. Patients who have been known to have been allergic to macromolecular protein preparations or known to be allergic to any component of sindilimab; 6. Patients who have suffered from other malignant tumors (except those who have been cured or have survived without cancer for more than 5 years, such as basal cell carcinoma of skin, carcinoma in situ of cervix, papillary thyroid carcinoma, etc.); 7. Patients with heart clinical symptoms or diseases that can not be well controlled, such as NYHA grade 2 or above heart failure, unstable angina pectoris, myocardial infarction within one year, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, left ventricular ejection fraction at rest is less than 50%; 8. The subjects had active infection (need to use anti bacteria, virus and fungal drugs), or fever of unknown origin occurred during the screening period and within one week before the first administration of the drug > 38.5 degree C (according to the judgment of the researcher, the fever caused by tumor can be included in the group); 9. HIV positive patients; untreated active hepatitis B (HBsAg positive and peripheral blood HBV-DNA titer >=1000IU / ml or copy number positive value detected by the research center; hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the detection limit of the analysis method)); 10. Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or patients with active pulmonary tuberculosis infection within one year before enrollment, or patients with active pulmonary tuberculosis infection history more than one year ago but without regular treatment; 11. Subjects are participating in other clinical studies or less than 4 weeks from the end of the previous clinical study; 12. Subjects had previously received other PD-1 and / or PD-L1, or CTLA-4 antibody therapy, or other drug therapy for immune receptor modulators; 13. Patients vaccinated with live vaccine within 4 weeks before screening; 14. Subjects were known to have a history of psychotropic substance abuse, alcoholism or drug use; 15. Pregnant or lactating women; 16. Any mental condition that hinders understanding or providing informed consent; 17. Patients with allergic history of similar oncolytic virus biological agents; 18. Patients with malignant hematological diseases; 19. Patients with uncontrolled active infection; 20. Patients who are taking antiviral drugs or high-dose corticosteroids; 21. Patients with immune deficiency and immunosuppression;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| event-free survival (EFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival (OS);safety;necrosis rate;disease control rate (DCR);recurrent rate; | — |
Countries
China
Contacts
Public ContactShuier Zheng
Shanghai Sixth People's Hospital
Outcome results
None listed