Malignant solid tumor
Conditions
Interventions
Experimental group:New oncolytic virus preparation:
1 × 10^7-9 pfu/kg, intravenous injection, chest, abdominal, intrathecal, intratumoral injection, or simultaneous injection, once a week until progre
Sponsors
Foresea Life Insurance Nanning Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old=10 mm (if it is a lymph node, a short axis >=15 mm) is required (brain metastasis is not the only measurable lesion); 2. Positive test for circulating tumor cells transferred to the blood. 5. At least 30 days or more than 5 half-lives after the patient received the last anti-tumor therapy before enrollment; Surgical treatment for 30 days; The end time of the last interventional treatment is greater than 30 days. 6. Model of End-Stage Liver Disease (MELD) score =30 g/L, serum ALT=80 g/L; ANC>=1.5×10^9/L; PLT>=70×10^9 /L. 12. Patients must have recovered from prior treatment toxicities to grade <=1, with the exception of alopecia and grade 2 prior platinum-containing therapy-related neuropathy (CTCAE 5.0). 13. No second tumor within the past 5 years; 14. Able to understand the situation of this study, the patient and/or legal representative voluntarily agrees to participate in this trial and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who have a history of allergy to oncolytic viruses and their metabolites or their pharmaceutical excipients (whether active or not). 2. Received anti-tumor drugs such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 30 days before the first use of the study drug. Those who have participated in any drug or medical device clinical trial within 30 days before the trial. 3. Major organ surgery (excluding needle biopsy) or significant trauma within 30 days before the first use of study drug. 4. Adverse reactions of previous anti-tumor therapy have not recovered to CTCAE 5.0 grade evaluation = grade 3. 6. Other uncontrolled active infections. 7. History of immunodeficiency, including positive HIV antibody test. 8. Active hepatitis B (HBV) or hepatitis C virus (HCV) infection. 9. History of severe cardiovascular disease: ventricular arrhythmias requiring clinical intervention; QTc interval> 480 ms; Acute coronary syndrome, congestive heart failure, stroke, or other grade III or above cardiovascular events within 6 months; New York Heart Association (NYHA) cardiac function grade >= II or left ventricular ejection fraction (LVEF) < 50%; Uncontrolled hypertension. 10. Mental disorders or poor compliance. According to the judgment of the investigator, objective conditions (including the patient's psychological state, family relationships, social factors or regional factors, etc.) prevent the patient from completing the planned study or the trial participants have other factors that may lead to the forced termination of this study. 11. Pregnant or lactating women. 12. The investigator believes that the trial participants have other serious systemic diseases or other reasons that are not suitable for participating in this clinical study. 13. Autoimmune diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Progression-Free-Survival (PFS);Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Quality of life (QOL);Safety; | — |
Countries
China
Contacts
Public ContactGuosheng Feng
Foresea Life Insurance Nanning Hospital
Outcome results
None listed