advanced mucosal malignant melanoma
Conditions
Interventions
experimental group :SHR-1210 combined with apatinib
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. The patient volunteered to join the study and signed an informed consent form; 2. Aged = 18 years, both men and women; 3. Clinically diagnosed or pathologically confirmed advanced mucosal malignant melanoma with at least one measurable lesion that has not been treated locally (this measurable lesion has a long-diameter =10 mm or enlargement according to RECIST v1.1) Lymph node short diameter = 15 mm); 4. Can swallow pills normally; 5. ECOG score: 0~1; 6. Expected survival = 12 weeks; 7. The function of vital organs meets the following requirements (no blood components, cell growth factors and other corrective medications are allowed within 14 days of the first dose): 1) the absolute count of neutrophils is =1.5×10^9/L; 2) platelets = 80 × 10^9 / L; 3) hemoglobin = 90 g / L; 4) serum albumin = 30g / L; 5) thyroid stimulating hormone (TSH) = 1 × ULN (if abnormalities should be investigated at the same time FT3, FT4 levels, such as FT3 and FT4 levels, can be included); 6) bilirubin = 1.5 × ULN (within 7 days before the first dose); 7) ALT and AST = 1.5 × ULN (within 7 days before the first dose); 8) serum creatinine = 1.5 × ULN. 8. Non-surgical sterilization or women of childbearing age need to use a medically approved contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period; Female patients of childbearing age who have undergone surgical sterilization must have a negative serum or urine HCG test within 72 hours prior to study enrollment; and must be non-lactating; for male patients with a partner of childbearing age, SHR-1210 should be given during the trial and at the end of the trial. Effective method of contraception within the next 3 months.
Exclusion criteria
Exclusion criteria: 1. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis) Hyperthyroidism; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adulthood; asthma patients who require bronchodilators for medical intervention cannot be included). 2. The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppressive purposes (dose > 10 mg/day of prednisone or other therapeutic hormones) and continues to be used for 2 weeks prior to enrollment; 3. Severe allergic reactions to other monoclonal antibodies; 4. Suffering from high blood pressure, and can not be well controlled by antihypertensive drugs (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg); 5. There are clinical symptoms or diseases of the heart that are not well controlled, such as: 1) NYHA class 2 or higher heart failure; 2) unstable angina; 3) have a myocardial infarction within 1 year; 4) clinically significant supraventricular or ventricular arrhythmia requires treatment or intervention ?QTc>450ms (male); QTc>470ms (female); 6. Coagulation dysfunction (INR>2.0, PT>16s), bleeding tendency or receiving thrombolysis or anticoagulant therapy, allowing prophylactic use of low-dose aspirin, low molecular weight heparin; 7. There are significant clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment, such as cough/hemoptysis 2.5ml and above lower gastrointestinal bleeding, esophageal varices with bleeding risk, hemorrhagic Stomach ulcer or vasculitis; 8. Events of arterial/venous thrombosis occurring within the first 6 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; 9. Known hereditary or acquired bleeding and thrombophilia (eg hemophilia patients, coagulopathy, thrombocytopenia, etc.); 10. Urine routine indicates that urine protein = ++ and confirmed 24-hour urine protein amount > 1.0g; 11. Patients who have previously received radiotherapy, chemotherapy, hormonal therapy, surgery, and less than 4 weeks before the completion of treatment (last dose); molecular targeted therapy (including oral targeting drugs for other clinical trials) from the first study 15×109/L; or suppurative and chronic infection, the wound does not heal; 13. Patients who had developed bone metastases had a palliative radiotherapy area > 5% of the bone marrow area within 4 weeks prior to participation in the study; 14. The patient has previously received anti-PD-1, anti-PD-L1, anti-PD-L2 treatment; the patient has been treated with apatinib; 15. Those known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components; 16. Skin melanoma, ocular melanoma, primary unexplained melanoma; 17. The local invasion of the mucosal dilute primary lesion is severe, and there is a risk of organ leakage or major bleeding or pe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;TTR;DoR;DCR;6-month survival rate;9-month survival rate;12-month survival rate;OS; | — |
Countries
China
Contacts
Public ContactZhengyun Zou
Nanjing Drum Tower Hospital
Outcome results
None listed