Melanoma
Conditions
Interventions
Treatment group:TIL and Treprizumab
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in clinical research; understand and be informed of this research, and sign an informed consent; willing to follow all trial procedures; 2. Male or female subjects 18-75 years old; 3. For locally advanced or metastatic melanoma confirmed by histology or cytology, at least one lesion that can be used for resection is more than 1 cm3; 4. According to the RECIST 1.1 standard, there is at least one measurable lesion, that is, non-lymph node lesions long diameter >= 10 mm, or lymph node lesions short diameter >= 15 mm according to dermatoscope, CT or MRI cross-sectional images; 5. The Eastern Cooperative Oncology Group (ECOG PS) score is 0 to 1; 6. The expected survival period is not less than 12 weeks; 7. Organ function and hematopoietic function must meet the following requirements: (1) Hemoglobin (HGB) >= 90g/L, no blood transfusion within two weeks; (2) White blood cell count (WBC) >= 2.5 x 10^9/L; (3) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; (4) Platelet count (PLT) >= 80 x 10^9/L; (5) Total bilirubin (TBIL) = 50 mL/min; (8) Prothrombin time (PT): INR<1.7 or prolonged, PT prolonged time is less than 4 seconds than normal; (9) Nervous system assessment is normal; 8. Be able to receive treatment and follow-up, including subjects who need to receive treatment at the enrollment center; 9. Female subjects of childbearing age must take effective contraceptive measures from signing the informed consent to the entire study period to minimize the possibility of pregnancy during the trial period, and they must not breastfeed. Male subjects also require effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. Female subjects during pregnancy or lactation; 2. Active hepatitis B (hepatitis B surface antigen is positive and the DNA test value is higher than the minimum detection limit), or subjects with active hepatitis C; 3. HIV/AIDS infection; 4. Other active infections with significant clinical significance; 5. Subjects with the following pre-existing diseases or concomitant diseases: the subject is diagnosed with a severe autoimmune disease, needs systemic immunosuppressant (steroid) treatment for a long time (more than 2 months), or has immune-mediated symptomatic diseases , Including ulcerative colitis, Crohns disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune vasculitis (such as Wegeners granulomatosis); 6. Subjects who have been previously diagnosed with motor neuron disease; 7. Subjects with previous toxic epidermal necrolysis (TEN); 8. Suffer from any mental illness, including dementia, changes in mental status, which may affect the subject of informed consent and relevant questionnaire understanding; 9. It is determined by the study to have a serious uncontrollable disease, which may affect the subjects receiving the treatment of this study; 10. Suffered from other active malignant tumors in the past 5 years, such as basal or squamous skin cancer, superficial bladder cancer; 11. The subject is being treated with systemic steroids or steroid inhalants; 12. Subjects allergic to immunotherapy or related drugs; 13. Those with meningeal metastasis or central nervous system metastasis, and those who have a clear basic central nervous system disease in the past 6 months and have left significant symptoms; 14. NYHA heart failure grade >= 2 or the standard treatment of hypertension cannot be controlled, subjects who need special treatment, patients with a previous history of myocarditis, or patients with myocardial infarction within one year; 15. Subjects who have previously received an organ transplant or plan to receive an organ transplant; 16. Patients with active bleeding; 17. Patients with pleural and abdominal effusion who need clinical treatment or intervention; 18. Subjects judged by the investigator to be unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-related serious adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactGu Jianying
Zhongshan Hospital, Fudan University
Outcome results
None listed