melanoma
Conditions
Interventions
Experimental group:Bevacizumab combined with toripalimab and dacarbazine
Sponsors
Shandong First Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75, no gender limit; 2. According to histological or cytological confirmation, it is late stage (stage IV) according to the AJCC 8th edition guidelines. Malignant melanoma; including: cutaneous, mucosal, acral and choroidal malignant melanoma tumor; 3. Have not received treatment for malignant melanoma in the past; 4. ECOG score is 0 or 1; 5. Expected survival =3 months; 6. Patients with wild-type BRAF mutation; 7. At least one measurable lesion according to RECIST 1.1 criteria; 8. Organ function levels must meet the following requirements (7 days before the first dose of study drug): ? Bone marrow: absolute neutrophil count (ANC) = 1.5×10^9/L, platelets (PLT) = 100×10^9/L, hemoglobin (HB) =10 g/dL (no blood transfusion within 14 days before the test); ? Liver: Serum total bilirubin (TBIL) =1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5 × ULN (if there is liver metastasis, AST, ALT=5×ULN); ? Serum creatinine = 1.5 × ULN and endogenous creatinine clearance = 50mL/min (Cockcroft-Gault formula); ? International normalized ratio (INR), activated partial thromboplastin time (aPTT) = 1.5 × ULN (applicable only to patients not receiving anticoagulation; patients receiving anticoagulation should keep anticoagulants within the therapeutic range required); ? Thyroid stimulating hormone (TSH) =1×ULN (if abnormal, FT3 and FT4 levels should be examined at the same time. If the FT3 and FT4 levels are normal, you can be included in the group); ? Urinary protein =1+, if urine protein >1+, 24-hour urine protein measurement needs to be collected and the total amount Requires =1 gram; ? If the electrocardiogram is normal or abnormal, it has no clinical significance. If the subject is suspected of abnormal cardiac function, Normal, have relevant past medical history, or other researchers believe that further cardiac function testing is needed. To judge the situation, cardiac ultrasound should show that the left ventricular ejection fraction (LVEF) is greater than 50%; 9. Women of childbearing age must have a negative serum pregnancy test result within 7 days before the first administration of the experimental drug; Men of reproductive potential or women with the possibility of pregnancy must use highly effective Contraceptive methods (such as oral contraceptive pills, intrauterine devices, libido control, or barrier methods combined with spermicide dose) and continue contraception for 12 months after the end of treatment; 10. Subjects voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Have a history of other malignant tumors other than malignant melanoma in the past 5 years, but have cured skin lesions Exceptions include basal cell carcinoma, cutaneous squamous cell carcinoma, early prostate cancer, and cervical carcinoma in situ; 2. Subjects have previously used immune checkpoint inhibitors or anti-angiogenic drugs or dacarbazine treatment; 3. Patients who are allergic to the active ingredients and excipients of bevacizumab, toripalimab and dacarbazine; 4. The subject has clinical symptoms of central nervous system metastasis (such as cerebral edema, need for hormonal intervention, or brain metastasis progression); 5. Have cardiac clinical symptoms or diseases that cannot be well controlled; 6. Abnormal coagulation function (INR>1.5 or PT>16s), bleeding tendency or currently receiving thrombolysis or anticoagulation treat; 7. Those who have clinical symptoms of ascites, pleural effusion, or pericardial effusion and require therapeutic puncture or drainage, For example, after drainage of pleural effusion or pericardial effusion and before the first administration of the first study drug, the patient should be observed to stabilize for at least 2 weeks. Those who are determined can be included in the research; 8. The subject has active infection or develops unexplained fever during the screening period and before the first dose> 38.5?; 9. Those who have used other clinical trial investigational drugs within 4 weeks before the first medication; 10. Have received live vaccines less than 4 weeks before study medication or may be vaccinated during the study period; 11. In the judgment of the researcher, the subject has other factors that may cause the study to be terminated midway. For example, other serious diseases (including mental illness) require combined treatment, and severe laboratory tests abnormality, accompanied by family or social factors, which may affect the safety of the subjects, or the data and samples collection of items
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression Free Survival;Disease Control Rate;Adverse Reactions; | — |
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Countries
China
Contacts
Public ContactZhu Dongyuan
Shandong First Medical University Affiliated Cancer Hospital
Outcome results
None listed