Late stage solid tumors
Conditions
Interventions
Interventional group:Three groups of patients start with a concentration of 10^6 pfu/mL and follow a dose escalation plan. Each subject receives only one injection at the corresponding concentration,
diameter 1.5-2.5 cm, maximum of 2 mL
diameter greater than 2.5 cm, maximum of 4 mL). The second dose is administered three weeks after the first dose, followed by subsequent doses at two-week intervals.
After enrollment, subjects in each
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1)Male or female patients: =18 years; =70 years. 2)Histologically confirmed, second-line treatment ineffective, advanced recurrent/metastatic solid tumors (including but not limited to head and neck squamous cell carcinoma, nasopharyngeal carcinoma, melanoma, etc.). 3)ECOG performance status score: 0-1. 4)Expected survival =3 months. 5)Time since the last chemotherapy/radiotherapy/surgery is more than 28 days. 6)Time since the last use of nitrosourea or mitomycin C is more than 6 weeks. 7)Adequate organ function, as defined by the following criteria within 14 days before randomization: Hematology: Hemoglobin =90g/L (without blood transfusion in the last 14 days); Neutrophil count >1.5×109/L; Platelet count =80×109/L. Biochemistry: Total bilirubin =1.5×ULN (upper limit of normal); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =2.5×ULN; if there is liver metastasis, ALT or AST =5×ULN; Estimated glomerular filtration rate =60ml/min (Cockcroft-Gault formula). Cardiac Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) =50%. 8)Signed written informed consent Subjects must sign a written informed consent form approved by the competent authority and the research institution and date it. The informed consent form must be signed before any protocol-related procedures (not part of the subject's routine medical care) are conducted. Subjects must be willing and able to comply with the scheduled visits, treatment regimen, laboratory tests, and other requirements of the study.
Exclusion criteria
Exclusion criteria: 1)Participated in another drug clinical trial within the past 4 weeks. 2)Tumor located near major blood vessels or the trachea. 3)Has poorly controlled clinical heart symptoms or diseases, such as NYHA class 2 or higher heart failure, unstable angina, myocardial infarction within the past year, clinically significant ventricular or supraventricular arrhythmias requiring treatment or intervention. 4)For female subjects: pregnant or lactating women. 5)Patients with active pulmonary tuberculosis, bacterial or fungal infections (= grade 2 of NCI-CTCAE 5.0); active HIV infection, active HBV infection, HCV infection. 6)Has a history of substance abuse that cannot be discontinued or has psychiatric disorders. 7)Has any active autoimmune disease or a history of autoimmune disease, including but not limited to uveitis, enteritis, pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or childhood asthma that has completely resolved in adulthood without the need for intervention may be included; subjects with asthma requiring bronchodilators for medical intervention cannot be included. 8)Subject is receiving immunosuppressive treatment. 9)Has a history of substance abuse or known medical, psychological, or social conditions, such as a history of alcoholism or drug abuse. 10)Known allergy, hypersensitivity reaction, or intolerance to oncolytic virus research (including any excipients). A history of severe allergies to any drugs, foods, or vaccines, such as anaphylactic shock, angioedema, respiratory distress, purpura, thrombocytopenic purpura, or localized allergic necrotizing reaction (Arthus reaction), etc. 11)Female subjects with pregnancy plans during the screening period or male subjects with partners who have pregnancy plans. 12)Has accompanying diseases judged by the investigator to be seriously harmful to patient safety or affecting the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal Tolerated Dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy evaluation (CR, PR, SD, PD, DOR, PFS, OS); | — |
Countries
China
Contacts
Public ContactXingchen Peng
West china hospital, Sichuan University
Outcome results
None listed