A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Advanced Solid Tumors

Inclusion Criteria:

1. Patients with advanced solid tumors clearly diagnosed by histology and/or cytology.
2. Failure of standard treatment or patient unwillingness to receive other antitumortherapy.
3. Age 18 to 75 years.
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 or intraperitoneal 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 c) serum total bilirubin (TBIL) ≤ 2 times the upper limitof normal values; d) glutamic aminotransferase (ALT) and glutamic oxalaceticaminotransferase (AST) ≤ 2.5 times the upper limit of normal values; subjects withliver metastases do not exceed 5 times the upper limit of normal values; e) activatedpartial thromboplastin time (APTT), prothrombin time (PT) within 1.5 times the upperlimit of normal 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.
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 severe prior interstitial lung changes (as determined by theinvestigator).
6. Patients with active tuberculosis and a strong positive OT test.
7. Patients with active bleeding or severe coagulation dysfunction.
8. Have had antitumor therapy, including endocrine, chemotherapy, radiotherapy, targetedtherapy, immunotherapy and antitumor herbal therapy, 4 weeks prior to the first dose.
9. Have not recovered to CTCAE 4.0 grade rating 0 or 1 level of toxicity after previousantineoplastic therapy.
10. Current active hepatitis B, active hepatitis C, immunodeficiency virus or other activeinfection of clinical significance.
11. Patients who have undergone surgery of grade 3 or higher or whose surgical wounds havenot healed within 4 weeks prior to enrollment.
12. Pregnant, lactating and planning to have children within six months.
13. Subjects who, in the judgment of the investigator, are unsuitable for participation inthis trial for any reason.