A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Advanced Bone and Soft Tissue Tumors

Inclusion Criteria:

1. Age 16 to 75 years, diagnosed with soft tissue sarcoma or bone neoplasms clearly byhistology and/or cytology.
2. Failure of standard treatment or patient unwillingness to receive other antitumortherapy.
3. No absolute or relative centasis contraindiction.
4. Subjects with ECoG score of 0-2.
5. Expected survival of 3 months or more.
6. Have at least one measurable lesion (according to RECIST 1.1 criteria) that isamenable to intratumoral drug delivery.
7. Subjects must have appropriate organ function, and laboratory tests during thescreening period must meet the following requirements: a) absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets (PLT) ≥ 80 × 109/L, and hemoglobin (Hb) ≥ 85 g/L; b)serum creatinine (Cr) and blood urea nitrogen (BUN) within 1.5 times the upper limitof normal values; c) serum total bilirubin (TBIL) ≤ 2 times the upper limit of normalvalues; d) glutamic aminotransferase (ALT) and glutamic oxalacetic aminotransferase (AST) ≤ 2.5 times the upper limit of normal values; subjects with liver metastases donot exceed 5 times the upper limit of normal values; e) activated partialthromboplastin time (APTT), prothrombin time (PT) within 1.5 times the upper limit ofnormal values.
8. Any treatment for malignancy, including radiotherapy, chemotherapy and biologicalagents, must be discontinued 28 days prior to R130 treatment.
9. Eligible patients of childbearing potential must agree to use a reliable method ofcontraception (hormonal or barrier method or abstinence) with their partner for theduration of the trial and for at least 180 days after the last dose; female patientsof childbearing potential must have a negative urine pregnancy test within 7 daysprior to enrollment.
10. Subjects voluntarily sign an informed consent form and are in good compliance.

Exclusion Criteria:

1. Have had any serious adverse reactions associated with immunotherapy and have notrecovered to CTCAE 5.0 grade rating 0 or 1 level of toxicity after previousantineoplastic therapy.
2. Subjects with any severe and/or uncontrolled disease, including: a) poorly controlledhypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100mmHg); b) suffering from class I or higher myocardial ischemia or myocardialinfarction, arrhythmia (QTc ≥ 470 ms and ≥ grade 2 congestive heart failure (New YorkHeart Association (NYHA) classification); c) active or uncontrolled severe infection (≥ CTCAE grade 2 infection); d) Patients with previous organ transplantation, bonemarrow transplantation (hematopoietic stem cell transplantation) and severe immunedeficiency; e) Urine routine suggesting urine protein ≥++ and confirmed 24-hour urineprotein quantification > 1.0 g.
3. Patients with past history of type I diabetes mellitus or HIV.
4. Severe abnormalities in thyroid and cortisol testing; active, known or suspectedautoimmune disease requiring systemic therapy.
5. Patients with active tuberculosis and a strong positive OT test.
6. Patients with active bleeding or severe coagulation dysfunction.
7. Have had antitumor therapy, including endocrine, chemotherapy, radiotherapy, targetedtherapy, immunotherapy and antitumor herbal therapy, 4 weeks prior to the first dose.
8. Current active hepatitis B, active hepatitis C, immunodeficiency virus or other activeinfection of clinical significance.
9. Patients who have undergone surgery of grade 3 or higher or whose surgical wounds havenot healed within 4 weeks prior to enrollment.
10. Pregnant, lactating and planning to have children within six months.
11. Subjects who, in the judgment of the investigator, are unsuitable for participation inthis trial for any reason.