An Exploratory Single-arm Study: PD-1 With Recombinant Human Adenovirus Type 5 Injection for Malignant Melanomas

Exclusion Criteria

• •1. the injectable lesion has received other local treatment, such as ablation, intervention, or Hepatome, within the previous 6 months;
• •2. previous treatment with lysoviruses or similar drugs (e.g. T-VEC)
• •3. local lesions that do not meet the volume requirements for intratumoral injection or for which intratumoral injection is inappropriate
• •4. have received antiviral therapy, such as acyclovir, ganciclovir, vancomycin, adenosine, etc., within 4 weeks prior to the first dose of the trial treatment
• •5. known hypersensitivity to the study drug or its active ingredient, excipients or to anti-PD-1 monoclonal antibodies and their components
• •6. positive for hepatitis B surface antigen (HBsAg) and clinically judged to have active hepatitis B;
• •7. other active viral infections;
• •8. patients with any unstable systemic disease, including but not limited to: severe infection, uncontrolled diabetes mellitus, unstable angina pectoris, cerebrovascular accident or transient cerebral ischaemia, myocardial infarction, congestive heart failure, severe arrhythmia requiring pharmacological treatment, liver, renal or metabolic disease;
• •9. the presence of an autoimmune disease
• •10. the patient has a concomitant disease (e.g. mental illness, etc.) or condition (e.g. alcohol or drug abuse, etc.) that would increase the patient's risk of receiving the trial drug or would affect the patient's ability to comply with the requirements of the trial, or would have the potential to confound the results of the study
• •11. the patient has been treated with any other experimental drug or participated in another interventional clinical trial within 14 days prior to treatment in this study
• •12. women who are pregnant or breastfeeding or who are planning to become pregnant or breastfeeding during the study period; men or women who do not wish to use effective contraception
• •13. evidence of central nervous system metastases at baseline
• •14. other circumstances which, in the judgment of the investigator, make the patient unsuitable for participation in the clinical trial.