advanced malignant melanoma
Conditions
Interventions
experimental group:nab-paclitaxel, bevacizumab, toripalimab, radiotherapy
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 malignant melanoma (unresectable stage IIIC or stage IV melanoma) with at least one measurable lesion (this measurable lesion has a long-diameter >= 10 mm or enlargement Lymph node has a short-diameter >= 15 mm, according to RECIST v1.1); 4. Untreated advanced or metastatic melanoma, except in the following cases: previous targeted therapy or immunotherapy (such as anti-CTLA-4, anti-PD-1 therapy or interferon) as adjuvant or neoadjuvant therapy; enrollment was only permitted if no relapse occurred during immunotherapy or within 6 months after treatment discontinuation; no other prior adjuvant or neoadjuvant therapy was permitted; 5. Never received radiotherapy; 6. ECOG score: 0-1; 7. Expected survival >= 12 weeks; 8. Tumor biopsy can be provided; 9. 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 >= 1.5x10^9/L; (2) platelets >= 80x10^9/L; (3) hemoglobin >= 90 g/L; (4) serum albumin >= 30 g/L; (5) thyroid stimulating hormone (TSH) <= 1xULN (if abnormalities should be investigated at the same time FT3, FT4 levels, such as FT3 and FT4 levels, can be included); (6) bilirubin <= 1.5xULN (within 7 days before the first dose); (7) ALT and AST <= 1.5xULN (within 7 days before the first dose); (8) serum creatinine <= 1.5xULN; 10. 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 havent 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, effective method of contraception should be taken during the trial and within the next 3 months after the last dose.
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. History of other tumors; 4. Active infection requiring systemic treatment; 5. Severe allergic reactions to other monoclonal antibodies; 6. 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 > 450 ms (male); QTc > 470 ms (female); 7. Coagulation dysfunction (INR > 2.0, PT > 16 s), bleeding tendency or receiving thrombolysis or anticoagulant therapy, allowing prophylactic use of low-dose aspirin, low molecular weight heparin; 8. There are significant clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment, such as cough/hemoptysis 2.5 ml and above lower gastrointestinal bleeding, esophageal varices with bleeding risk, hemorrhagic Stomach ulcer or vasculitis; 9. 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; 10. Known hereditary or acquired bleeding and thrombophilia (e.g., hemophilia patients, coagulopathy, thrombocytopenia, etc.); 11. 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); 12. Urine routine indicates that urine protein >= ++ and confirmed 24-hour urine protein amount > 1.0g; 13. 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 < Five drug half-lives, or adverse events caused by prior treatment (except for hair loss) did not return to patients with <= CTCAE level 1; 14. Ocular melanoma, primary unexplained melanoma, brain metastases melanoma; 15. The local invasion is severe, and there is a risk of organ leakage or major bleeding or perforation; 16. Pregnant, lactating women, or female patients who have fertility but have not used contraception; 17. People with other malignancies at the same time; 18. Patients who participate in other clinical trials at the same time; 19. HIV positive; HCV positive; HBsAg or HBcAb positive patients also detected HBV DNA copy number positive (quantitative detection limit is 500 IU/ml); 20. Live vaccination received within 4 weeks prior to the start of treatment; 21. According to the investigator, other severe, acut
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;overall survival;time to objective response;duration of response;6-month survival rate;9-month survival rate;12-month survival rate;Quality of life; | — |
Countries
China
Contacts
Public ContactZhengyun Zou
Nanjing Drum Tower Hospital
Outcome results
None listed