Advanced melanoma
Conditions
Interventions
Experiment group:Oncolytic adenovirus combined with PD-1 inhibitors
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged from 18 to 75 years(contained boundary values),gender is not limited; 2. Malignant melanoma was diagnosed by histopathology; 3. The researchers judge that the current physical condition and expected treatment plan are suitable for the treatment plan of this study; 4. Patients with malignant melanin who have failed previous immunotherapy or cannot tolerate chemotherapy; 5. There must be an injectable lesion that meets the requirements of RECIST 1.1 and iRECIST measurable target lesion; 6. The longest diameter of injectable lesions must be >= 10mm and = 1.0 x 10^9/L; (2) Absolute value of neutrophils >= 1.0 x 10^9/L; (3) Platelet count >= 80 x 10^9/L; (4) Hemoglobin >= 70g/L; (5) INR = 50ml/min. 9. The interval between the first treatment in this study and the last previous antitumor treatment is >= 14 days, and the adverse reactions have recovered from the previous antitumor treatment to baseline or grade 1 (CTCAE 5.0 version) (except for alopecia and grade 2 anemia); 10. Sign the informed consent voluntarily; 11. Women with potential fertility (including early menopause, menopause < 2 years and non-surgical sterilization), men and their partners must consent to the use of effective contraceptive methods during the study period: surgical sterilization, oral contraceptives, intrauterine devices, sex-controlled or barrier contraceptive methods combined with spermicides; After receiving the last treatment, contraception must continue for 6 months.
Exclusion criteria
Exclusion criteria: 1. The injectable lesions have received ablation, intervention, HIFU Knife and other local treatments within the past 6 months; 2. Previous treatment with oncolytic virus drugs or similar drugs (such as T-VEC); 3. Local lesions cannot meet the requirements of intratumor injection volume or are not suitable for intratumor injection; 4. Received antiviral therapy, such as acyclovir, ganciclovir, vanacylovir, arabinosine, etc. within 4 weeks before the first administration of experimental therapy; 5. Known to be allergic to the study drug or its active ingredient or excipients, or to anti-PD-1 monoclonal antibody and its components; 6. Hepatitis B surface antigen (HBsAg) positive and clinically diagnosed as active hepatitis B; 7. Other active virus infection; 8. The patient has any unstable systemic disease, including but not limited to: severe infection, uncontrolled diabetes, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial infarction, congestive heart failure, severe arrhythmia requiring medical treatment, liver, kidney or metabolic disease; 9. Suffering from autoimmune diseases; 10. The patient has a medical condition (e.g. mental illness, etc.) or condition (e.g. alcohol or substance abuse, etc.) that increases the risk of the patient receiving the trial medication or affects the patient's compliance with the trial requirements, or is likely to confuse the results of the study; 11. The patient had received any other experimental drug therapy or participated in another interventionary clinical trial within 14 days prior to receiving treatment in the study; 12. Pregnant or lactating women or women preparing to be pregnant or lactating during the study period; Men or women who do not want to use effective contraception; 13. Evidence of central nervous system metastasis at baseline; 14. Other conditions in which the investigator judged the patient unsuitable for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Disease Control Rate;Overall Survival;Quality of Life; | — |
Countries
China
Contacts
Public ContactChen Yu
Fujian Cancer Hospital
Outcome results
None listed