Malignant melanoma
Conditions
Interventions
experimental group:Oncorine+PD-1 mAb
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years, regardless of gender; 2. Patients diagnosed as malignant melanoma by histopathology (only skin and extremities); 3. Patients who failed in previous treatment or could not tolerate chemotherapy received 2-line system treatment at most (without previous treatment of PD-1 and PD-L1 monoclonal antibody); 4. There must be a patient with an injectable focus, and the focus must meet the requirements of RECIST 1.1 and RECIST measurable target focus; 5. For patients whose longest diameter of injectable focus must be >= 10 mm and = 3.0 * 10^9 / L, neutrophil absolute value >= 1. 5* 10^9 / L, platelet count >= 100 * 10^9 / L, hemoglobin >= 90g / L; INR = 50ml / min 8. The interval between the date of first treatment and the date of last previous anti-tumor treatment was >= 14 days, and the adverse reactions recovered from the previous anti-tumor treatment to the baseline or below level 1 (CTCAE version 5.0) (except hair loss and level 2 anemia); 9. Patients who voluntarily sign informed consent; 10. Female patients with fertility potential (including premenopause, menopause < 2 years and non-surgical sterilization), male patients and male patients' partners must agree to use effective contraceptive measures during the study period: surgical sterilization, oral contraceptives, intrauterine contraceptives, abstinence or barrier contraceptive method combined with spermicide; and continue contraception for 6 months after the last treatment.
Exclusion criteria
Exclusion criteria: 1. Patients with injectable lesions who have previously received ablation, intervention, Haifu knife and other local treatment; 2. Patients who have previously received oncolytic virus drugs or similar drugs (such as t-vec); 3. Patients whose local lesions can not meet the requirements of the volume of intratumoral injection or are not suitable for intratumoral injection; 4. Patients with malignant pleural effusion and ascites; 5. Patients who had received antiviral treatment within 4 weeks before the first administration of the trial treatment, such as acyclovir, ganciclovir, valaciclovir, adenosine arabinoside, etc.; 6. Patients who are known to be allergic to the study drug or its active ingredients, excipients or to the anti-PD-1 monoclonal antibody and its components; 7. Patients with HBsAg positive and clinically determined as active hepatitis B; 8. Hepatitis C virus (HCV) antibody, Treponema pallidum (TP) antibody and human immunodeficiency virus (HIV) antibody positive patients; 9. Patients with other (including unknown primary) cancer history within 5 years before the first administration of the trial treatment, except for the following: cured non melanoma skin cancer; cervical carcinoma in situ; radical I Stage I uterine cancer; radical breast ductal carcinoma in situ or lobular carcinoma in situ, which has not received any systemic treatment at present; localized prostate cancer which has received radical surgery and is considered to have been cured at present; solid tumor which has been cured for more than 5 years without recurrence; 10. Patients with any unstable systemic diseases, including but not limited to: serious infection, uncontrolled diabetes, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial infarction, congestive heart failure, serious arrhythmia requiring drug treatment, liver, kidney or metabolic diseases; 11. Patients with autoimmune diseases; 12. The disease (such as mental illness) or condition (such as alcohol or drug abuse) associated with the patient will increase the risk of the patient receiving the trial drug treatment or affect the patient's compliance with the trial requirements, or may confuse the research results; 13. Within 14 days before receiving the treatment of this study, the patient had received any other trial drug or participated in another intervention clinical trial; 14. Pregnant or lactating women or women preparing to be pregnant or lactating during the study; men or women who are unwilling to take effective contraceptive measures; 15. Patients with evidence of central nervous system metastasis at baseline; 16. Other conditions that the investigator judges the patient is not suitable to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DOR;DCR;PFS; | — |
Countries
China
Contacts
Public ContactQing Xu
Shanghai Tenth People's Hospital
Outcome results
None listed