malignant melanoma
Conditions
Interventions
Test group:Voronib + Alpalolito Vorizumab
Sponsors
Cancer Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years, gender is not limited; 2. Locally advanced or metastatic malignant melanoma confirmed by histology or cytology and unresectable (unresectable malignant melanoma needs to be discussed by MDT), including: dermal type, mucosal type, extremity type malignant melanoma; 3. No previous systemic treatment for locally advanced or metastatic malignant melanoma that is unresectable; 4. ECOG score of 0 or 1; 5. Expected survival >= 3 months; 6. BRAF V600 mutant wild type or undetermined patients; 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 the study drug): (1) bone marrow: absolute neutrophil count (ANC) >= 1.5 × 10^9/L, platelet (PLT) >= 100 × 10^9/L, hemoglobin (HB) >= 10 g/dL (no blood transfusion within 14 days before detection); (2) liver: serum total bilirubin (TBIL) = 50 mL/min (Cockcroft-Gault formula); (4) international standard ratio (INR), activated partial thromboplastin time (aPTT) 1 +, need to collect 24 hours urine protein measurement, the total amount should be <= 1 gram; (7) ECG normal or abnormal no clinical significance, if the subject suspected heart In cases of functional abnormalities, relevant past medical history, or other situations where the investigator believes that further cardiac function judgment is required, left ventricular ejection fraction (LVEF) should be greater than 50% on cardiac ultrasound; 9. Women of childbearing age must have a negative serum pregnancy test result within 7 days before the first dose of the test drug; men of reproductive capacity or women with the possibility of pregnancy must use highly effective contraceptive methods (such as oral contraceptives, intrauterine devices, controlled sexual desire or barrier contraception combined with spermicides) throughout the course of the test, and continue contraception for 12 months after the end of treatment; 10. Subjects voluntarily join the study, sign informed consent, comply well, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Have a history of malignant tumors other than malignant melanoma in the past 5 years, except for cured skin basal cell carcinoma, skin squamous cell carcinoma, early prostate cancer and cervical carcinoma in situ; 2. Those who have received anti-tumor treatment such as chemotherapy, radiotherapy, and ablation within the first 4 weeks; Those who have used traditional Chinese medicine or proprietary Chinese medicine with anti-tumor effect in the first 2 weeks; The end time of adjuvant therapy is less than 6 months; 3. Patients who are allergic to the active ingredients and excipients of voronib or ipalolito vorizumab; 4. Subjects with clinical symptoms of central nervous system metastases (such as cerebral edema, need for hormonal intervention, or brain metastasis progression); 5. There are cardiac clinical symptoms or diseases that are not well controlled; 6. Abnormal coagulation function (INR > 1.5 or PT > 16s), bleeding tendency or receiving thrombolytic or anticoagulant therapy; 7. Clinical symptoms of ascites, pleural effusion, pericardial effusion, requiring therapeutic puncture or drainage, such as pleural effusion, pericardial effusion, and those who observe stability for at least 2 weeks before the first administration of the study drug can be included in the study; 8. Subjects with active infection or unexplained fever > 38.5 ° C during the screening period and before the first administration; 9. Those who have used other drugs in clinical trial studies within 4 weeks before the first administration; 10. Live vaccines may be administered less than 4 weeks before or during the study; 11. According to the investigator's judgment, the subjects have other factors that may cause the study to be forced to terminate halfway, such as other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subjects, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Progression-free survival;6-month survival rate;Overall survival; | — |
Countries
China
Contacts
Public ContactZhu Dongyuan
Cancer Hospital Affiliated to Shandong First Medical University
Outcome results
None listed