malignant melanoma
Conditions
Interventions
Case series:ankerei (recombinant human adenovirus type 5 injection) combined with PD-1 monoclonal antibody and anti vascular drugs
Sponsors
Shanghai Dermatology Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years old; 2. Malignant melanoma was diagnosed by histopathology; 3. Patients with liver metastases who have previously failed to receive the first line or more systemic treatment (chemotherapy, targeted therapy and immunomonotherapy are not limited); 4. There must be an injectable lesion and the lesion must meet RECIST 1.1 measurable target lesion; 5. ECoG physical condition score 0-2; 6. Laboratory inspection must meet the following standards: WBC count >=3.0x10^9/L, neutrophil absolute value >=1.5x10^9/L, platelet count >=100x10^9/L, hemoglobin >=90 g/L INR =50ml/min or serum creatinine <=1.5 ULN; 7. The interval between the first treatment date of this study and the last anti-tumor treatment date was more than 21 days, and the adverse reactions of previous anti-tumor treatment had recovered to baseline or below grade 1 (except alopecia and grade 2 anemia) from the previous anti-tumor treatment; 8. Sign informed consent voluntarily; 9. Women with fertility potential (including early menopause, 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 devices, abstinence or barrier contraception combined with spermicide; and continue contraception for 6 months after the last treatment.
Exclusion criteria
Exclusion criteria: 1. The injectable lesions have been treated with ablation, interventional therapy, HIFU and other local treatments; 2. Have received oncolytic virus drugs or similar drugs (such as t-vec), PD-1 or PD-L1 combined with anti vascular therapy; 3. Local lesions can not meet the requirements of intratumoral injection volume or are not suitable for intratumoral injection; 4. With malignant pleural effusion and ascites; 5. Antiviral treatment, such as acyclovir, ganciclovir, valaciclovir, arabinoside, etc., was received within 4 weeks before the first administration of experimental treatment; 6. Those who are known to be allergic to the study drug or its active ingredients and excipients, or to anti PD-1 mAbs, anti vascular drugs and their components; 7. Hepatitis B surface antigen (HBsAg) positive and HBV DNA copy number > 1 × 103 copies / ml; 8. Hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antibody positive; 9. Patients with a history of other (including unknown primary) malignant tumors within 5 years before the first administration of the trial treatment, except for the following: Non melanoma skin malignancies cured Carcinoma in situ of cervix Stage I uterine cancer cured At present, there is no systemic treatment for breast ductal carcinoma in situ or lobular carcinoma in situ Localized prostate cancer that has been treated with radical surgery There was no sign of recurrence in the solid tumors treated for more than 5 years 10. The patient has any unstable systemic disease, including but not limited to: severe infection, uncontrolled diabetes mellitus, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia, myocardial infarction, congestive heart failure, severe arrhythmia requiring drug treatment, liver, kidney or metabolic disease; 11. Suffering from autoimmune diseases; 12. The disease (such as mental illness, etc.) or condition (such as alcoholism or drug abuse) associated with the patient will increase the risk of receiving the trial drug treatment or affect the patient's compliance with the trial requirements, or may confuse the research results; 13. Within 30 days before screening, the patient had received any other trial drug treatment or participated in another intervention clinical trial; 14. Pregnant or lactating women or women who are going to be pregnant or lactating during the study period; men or women who are unwilling to take effective contraceptive measures; and; 15. There was evidence of central nervous system metastasis at baseline, except that neurological symptoms recovered to ctcae5.0 after treatment Grade 1 or below for at least 8 weeks (except for treatment-related residual signs or symptoms), and systemic hormone therapy (dosage > 10mg / D, prednisone or other effective hormones) has been stopped for more than 2 weeks, and there is no disease progression on cranial MRI within 28 days before administration; 16. Other situations in which the investigator judged that the patient was not suitable to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Countries
China
Contacts
Public ContactXianling Guo
Shanghai Dermatology Hospital
Outcome results
None listed