Advanced sarcoma, pancreatic cancer, primary hepatic cancer, head and neck tumors, and gynecological tumors
Conditions
Interventions
Experimental group:Recombinant human IL-21 oncolytic vaccinia virus injection (hV01)
Sponsors
Xiamen Humanity Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Signing an informed consent form; 2.Men or women aged 18 to 75 years; 3.Histologically and/or cytologically confirmed advanced sarcoma, pancreatic cancer, primary hepatic cancer, head and neck tumor, and gynecological tumors refractory or failed to respond to standard therapies; 4.At least one measurable lesion according to RECIST v1.1 criteria, which can be injected intratumorally either directly or with the assistance of medical imaging equipment such as B-ultrasound, CT, or EUS fine-needle aspiration device. The baseline longest diameter of the lesion targeted for injection should be more than 1.5 cm. Note: Lesions that received radiotherapy should not be selected as target lesions unless unequivocal progression is demonstrated; 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; 6.Life expectancy of at least 3 months; 7. Major organ functions are basically normal: (1) Hematology: Absolute Neutrophil Count (ANC) >= 1.5×10^9/L, Platelets (PLT) >= 75×10^9/L, Hemoglobin (Hb) >= 90 g/L (no supportive treatment received in the 14 days prior to laboratory testing); (2) Liver function: Serum Total Bilirubin (TBIL) = 45 mL/min: Male creatinine clearance = [(140-age) × weight (kg)] / [0.818 × creatinine (µmol/L)]; Female creatinine clearance = [(140-age) × weight (kg) × 0.85] / [0.818 × creatinine (µmol/L)]; (4) Coagulation function: Activated Partial Thromboplastin Time (APTT) = 50, if they have been menopause for 12 months or more before the planned randomization date with no other medical causes, they are considered to be postmenopausal. For women aged < 50, if menopause has occurred for 12 months or more after discontinuing exogenous hormone therapy, and their Follicle Stimulating Hormone (FSH) levels are within menopause range, they are considered to be postmenopausal.
Exclusion criteria
Exclusion criteria: 1.Receiving any of the following anti-tumor treatments within a specified time period: (1) Systemic anti-tumor treatment, including chemotherapy, large-molecule targeted therapy, immunotherapy, and endocrine therapy within 4 weeks before first dose (within 6 weeks of dosing for nitrosourea or mitomycin C); (2) Small-molecule targeted therapy within 2 weeks before first dose or within 5 half-lives of the small-molecule targeted drug (whichever is longer); (3) Traditional Chinese medicine or Chinese herbal medicine used as anti-tumor agent within 2 weeks before first dose; (4) Radiotherapy (excluding palliative radiotherapy) within 2 weeks before first dose; 2.Acute toxic effects from prior treatments not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v5.0) grade 1 or below, except for toxicities deemed safe by the investigator, such as alopecia; 3.Receiving any investigational drug for clinical trials within 4 weeks prior to the first dose; 4.Undergoing any therapeutic surgeries (excluding diagnostic surgery or biopsy) within 4 weeks before the first dose, or there is a scheduled surgery while the patient is participating in the study; 5.Patients with clinical symptoms of central nervous system (CNS) metastasis or meningeal metastasis, or other evidence indicating that CNS or meningeal metastases are not controlled; 6.Known or suspected active autoimmune diseases (including but not limited to systemic lupus erythematosus, Sjogren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, and Hashimoto's thyroiditis); 7.History of severe cardiovascular and cerebrovascular diseases, including: (1) Acute coronary syndrome (including myocardial infarction, severe or unstable angina), myocarditis, congestive heart failure, cerebrovascular accidents, or other cardiovascular events of CTCAE (v5.0) grade 3 or higher within 12 months of dosing; (2) Severe arrhythmia requiring clinical intervention (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes); (3) New York Heart Association (NYHA) classification of class II or above, or left ventricular ejection fraction (LVEF) = 2000 IU/mL or >=10^4 copies/mL); 13.Receiving therapeutic dosages of corticosteroids such as prednisone or its equivalent >10 mg daily within two weeks prior to the first dose, or having any coexisting diseases that might require systemic corticosteroids or any other immune suppressors during the study (assessed by the investigators) with the following exceptions: local administration of glucocorticoid (e.g. topical routes such
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) and tolerability;Dose-limiting toxicities (DLTs); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Progression-Free Survival (PFS);Disease Control Rate (DCR);Duration of Response (DOR);Overall Response Rate (ORR); | — |
Countries
China
Contacts
Public ContactHuang Cheng
Xiamen Humanity Hospital
Outcome results
None listed