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\. Patients with unresectable stage III or IV malignant tumors confirmed by pathology and/or cytology; such as malignant melanoma, head and neck tumors, soft tissue sarcoma, liver tumors (primary hepatocellular carcinoma or liver metastases), biliary tract tumors, pancreatic cancer, esophageal cancer, gastric cancer, etc |
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\. Lack of standard effective treatment options, or failure of or relapse |
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after standard treatments |
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Male or female patients aged 18-75 years (inclusive); Eastern Cooperative |
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Oncology Group (ECOG) performance status score of 0-1; expected survival of |
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more than 3 months |
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\. At least 4 weeks have elapsed since completion of prior antitumor |
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therapies (including endocrine therapy, chemotherapy/radiotherapy, and |
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targeted therapy) (except radiotherapy for bone metastases); for patients |
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treated with nitrosoureas or mitomycin, at least 6 weeks since |
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discontinuation; and recovery from prior treatment-related adverse effects to |
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Grade 1 or lower |
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\. Patients who have undergone major surgery must be at least 4 weeks post- |
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operation |
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\. According to RECIST 1.1 criteria, at least one measurable target lesion is |
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required, with a lesion suitable for intratumoral injection. A measurable |
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tumor lesion is defined as having a longest diameter ≥10 mm with a scan slice |
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thickness ≤5.0 mm; for lymph node lesions, a short-axis diameter ≥15 mm |
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\. No severe dysfunction of major organs. 8\. Laboratory tests |
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WBC ≥3.0×10⁹/L, ANC ≥2.0×10⁹/L, Hb ≥90 g/L; PLT ≥100×10⁹/L; absolute lymphocyte count ≥0.8×10⁹/L |
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Blood urea nitrogen (BUN) and serum creatinine ≤1.5× the upper limit of normal (ULN) |
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Total bilirubin (TBIL) ≤1.5× ULN (for patients with hepatic involvement, TBIL ≤3× ULN) |
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ALT and AST ≤2.5× ULN; for patients with liver metastases, ≤5× ULN |
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Normal coagulation function (PT, APTT, and TT ≤1.5× ULN). 9\. Female subjects and their partners must use effective contraception during treatment and for 3 months after treatment |
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\. Subjects with genital herpes must have completed herpes resolution for at |
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least 3 months |
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\. Voluntary signing of the informed consent form, with expected good |
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compliance |
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\. Concomitant serious medical diseases, including uncontrolled diabetes, severe infections, or active gastrointestinal ulcers
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\. Presence of clinically significant cardiovascular or cerebrovascular
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disease, including
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Severe or uncontrolled heart disease requiring treatment, congestive heart failure classified as New York Heart Association (NYHA) class III or IV, unstable angina not controlled by medication, a history of myocardial infarction within the past 6 months, QTc interval on ECG ≥450 ms in males or ≥470 ms in females, or severe arrhythmias requiring drug treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia)
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Placement of a cardiac stent within the past 6 months
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Inadequately controlled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg
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Uncontrolled primary brain tumors or brain metastases. 4\. Bone metastases
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(except for bone metastases that are stable and controlled after treatment)
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or the presence of active, clinically symptomatic brain metastases
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\. Active autoimmune diseases requiring systemic treatment within the past 2
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years (including but not limited to rheumatoid arthritis, systemic lupus
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erythematosus, Sjögren's syndrome, etc., such as the use of disease-modifying
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drugs, corticosteroids, or immunosuppressive drugs). Replacement therapy
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(e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy
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for renal or pituitary insufficiency) is not considered a systemic treatment
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\. History of immunodeficiency (HIV antibody-positive), or other acquired or
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congenital immunodeficiency diseases, or a history of organ transplantation
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\. Uncontrolled psychiatric disorders or infectious diseases. Lesions that do
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not meet the volume requirements for intratumoral injection
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\. Patients with active hepatitis B or hepatitis C infection: those who are
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HBsAg-positive or HBcAb-positive with detectable HBV DNA copies (lower limit
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of quantification: 500 IU/mL); HBV DNA testing is mandatory at screening for
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such patients. Patients with a positive anti-HCV antibody test are eligible
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only if HCV RNA PCR testing is negative
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\. Positive HIV test result. 10\. Presence of active tuberculosis infection
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or other infectious diseases requiring systemic treatment
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\. Large amounts of pleural effusion or ascites accompanied by clinical
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symptoms or requiring symptomatic treatment
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\. Pregnant or breastfeeding women. 13\. Use of, or ongoing treatment with
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other investigational drugs or antiviral therapies within 4 weeks prior to
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treatment, except that patients with chronic hepatitis B receiving continuous
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treatment may use entecavir, tenofovir disoproxil fumarate, or adefovir
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dipivoxil
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\. Participation in another clinical study within the past 4 weeks. 15\
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Known allergy to herpes viruses or any components of the study drug. 16\. Any
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other condition that, in the investigator's judgment, makes the patient
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unsuitable for participation in this trial
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